Tagungen und Workshops zum Thema Biotechnologie

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Belgien (1) - China (2) - Deutschland (23) - Frankreich (1) - Großbritannien (4) - Indien (1) - Italien (5) - Kanada (2) - Marokko (1) - Namibia (1) - Niederlande (4) - Portugal (1) - Singapur (2) - Sri Lanka (1) - Thailand (2) - Tunesien (2) - Ungarn (1) - Vereinigte Arabische Emirate (1) - Vereinigte Staaten (30)

ALLE LÄNDER

1
3D Cell Culture
21. Feb 2018 - 22. Feb 2018 • London, Großbritannien
Zusammenfassung:
Building on the sell-out success of the launch event, SMi Group is delighted to announce the return of 3D Cell Culture, taking place on 21st and 22nd of February 2018, in London UK. 3D Cell Culture is rapidly growing with incredible potential for industrial application and a widespread reach that can be seen across many different fields, such as 3D bioprinting and microfluidics. The 2nd annual conference will explore these overlapping areas and will combine pioneering breakthroughs with scientific research to strengthen your commercial success. Join us for exclusive insight into key topics such as disease models, organoids, organ-on-a-chip technologies, Ipsc advances and CRISPR technology. Notable speakers on the agenda for 2018 will include experts from Aurelia Bioscience, ReInnervate Ltd, Cell and Gene Therapy Catapult, University College London, Novartis Institutes for Biomedical Research, Kugelmeiers, GSK, AstraZeneca, Roche and more!
Kontakt:
Teri Arri;     Tel.: [+44(0)207827 6162];     Email: tarri@smi-online.co.uk
Themen:
3D cell culture, bioimaging, bioprinting, organoid, spheroid, scaffold, microchips, ipsc, high throughput screening, cell line, stem cells, genome sequencing, CRISPR, drug discovery, regenerative medicine, regulatory update, MIP DILI, microfluidic, cell, biology, regenerative, cancer, medicine, well based screening, screening, cell based screening, assay, cell editing, in vitro, in vivo, single cell sequencing, disease, drug screening, multi organ chip, technology, cell therapy, cell manufacturing, tissue, organ
Eintrags-ID:
951859
2
Keystone Symposia: Antibodies as Drugs - Translating Molecules into Treatments
25. Feb 2018 - 01. Mär 2018 • Whistler, BC, Kanada
Zusammenfassung:
Antibodies carry an enormous potential in prophylaxis and treatment of human disease. Antibody therapies may be divided into two distinct but highly related disciplines. First, antibodies can be elicited de novo using vaccines. Our understanding of what constitutes an effective antibody response at the molecular level and the science of eliciting such antibodies in vivo is progressing rapidly. Second, isolated antibodies represent powerful drugs when developed as biopharmaceuticals, as demonstrated by the ever-expanding list of approved molecules as well as by the large number of antibody products in development in a wide range of therapeutic areas. The antibody landscape is changing as the field has moved from empirical to knowledge-based, designer approaches for which understanding of mechanisms of action at the molecular level is critical. Translating such basic knowledge into novel products and applications requires scientists from many disciplines including structural and cellular immunology, biology, engineering, chemistry and medicine to interact closely. Consequently, the field of antibody-based vaccines and therapeutics has become an interface area where experts meet and work together. The 2018 Keystone Symposia antibodies conference aims to provide a platform for knowledge-sharing from the molecular to the systems level to navigate the newest developments and insights to prevent, treat and cure major human diseases.
Kontakt:
Attendee Services;     Tel.: [970.262.1230];     Email: info@keystonesymposia.org
Themen:
vaccines, antibodies, drug development, immunology, translational medicine, cancer, biologics, macromolecular chemistry
Eintrags-ID:
975761
3
CfPIE - The Center for Professional Innovation & Education, Inc. — Development & Validation of Bioanalytical Assays for Biologics
26. Feb 2018 - 27. Feb 2018 • Berlin, Deutschland
Zusammenfassung:
Quantitation assays are critical for the development of biologics and biopharmaceuticals as well as accurate detection of protein biomarkers. Immunoassays for quantitation of protein drugs in biological matrices (ex. plasma, serum, tissue) generally take much longer to develop and are subject to a wider range of interferences than traditional xenobiotic small molecule quantitation assays by LC-MS/MS. Part 1 of this interactive two day course focuses on these critical assays and will take you step-by-step through the development of quantitation assays for proteins including monoclonal antibodies.
Kontakt:
Registration Department;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Immunogenicity Assays, Quantitation Assays, immunology, protein biomarkers, Immunoassays, biological matrices, Analytical Development
Eintrags-ID:
1006845
Verwandte Fachgebiete:
4
Biomarker Platforms and Biomarkers in Immuno-Oncology
01. Mär 2018 • Boston, Massachusetts, Vereinigte Staaten
Zusammenfassung:
This exciting one-day meeting will highlight new and emerging discoveries in biomarkers, in depth observation of immune activity and pathways, and an additional focus on researchers utilizing the FirePlex® biomarker profiling platform. Join us for this collaborative and engaging event that will provide insights into new techniques and markers, as well as how FirePlex® is being applied in immuno-oncology research.
Kontakt:
Abcam Events;     Tel.: [617-577-4269];     Email: events@abcam.com
Themen:
biomarkers, immuno-oncology, Abcam, science, FirePlex, immune
Eintrags-ID:
1009627
Verwandte Fachgebiete:
5
FOGM18 — The Future of Genomic Medicine
01. Mär 2018 - 02. Mär 2018 • La Jolla, Vereinigte Staaten
Zusammenfassung:
The 11th annual Future of Genomic Medicine conference will be the next iteration of taking genomic knowledge to transform the daily practice of medicine. To do this, we have patients present their story of how genomics affected their medical status, and have a faculty of experts in genomics, science and medical journalism, and the life science industry provide critical perspective. This year we will be paying attention to the exciting area of genomic editing to treat diseases, cancer (a disease of the genome), and the use of genetics for preventative medicine. Furthermore, we will delve into the hot topics of circulating free DNA-based diagnostics, epigenetics, and genomic analytics. The overarching goal of the conference is to spearhead efforts to use genomic knowledge to change medicine and make it far more precise and individualized.
Kontakt:
Corrine Yarbrough;     Tel.: [8587842133];     Email: cyarbro@scripps.edu
Themen:
The Future of Idividualized Medicine, Genome Editing, Data Science in Genetics and Genomics, Genetics of Human Origins and Adaptation, Circulating DNA and RNA, Predictive and Preventative Genetics, Epigenetics
Eintrags-ID:
984032
6
Course - The Center for Professional Innovation & Education — Auditing and Qualifying Suppliers and Vendors
01. Mär 2018 - 02. Mär 2018 • Boston, MA, Vereinigte Staaten
Zusammenfassung:
The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product. Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. Initially, the course will discuss the regulatory expectations and other industrial references/ standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services. During these sections, attendees will establish the documentation requirements, applicable audits and the impact of the quality agreement/contract details. For many years, the industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality system approach that the FDA and other regulatory agencies have come to expect from industry is critical.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Auditing, Qualifying, vendors, trials, outsourcing
Eintrags-ID:
1013535
7
Course - The Center for Professional Innovation & Education — Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
01. Mär 2018 - 02. Mär 2018 • Malvern, PA, Vereinigte Staaten
Zusammenfassung:
A robust audit program is a key stone of an effective Quality System. The need for internal (self-inspection) quality auditing has been recognized, and is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. In addition it is starting to become the industry expected "norm" in the area of pre-market clinical development.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Quality Assurance, Auditing, Audit Plans, Audit Checklists
Eintrags-ID:
1013533
8
Course - The Center for Professional Innovation & Education — Product Quality Reviews
01. Mär 2018 - 02. Mär 2018 • Los Angeles, CA, Vereinigte Staaten
Zusammenfassung:
Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Annual Product Review, ICH Q10, 21CFR820, ISO 9000, ISO 13485, GPG 7356.002, Quality System Review
Eintrags-ID:
1013658
9
4th Microbiome R&D and Business Collaboration Congress: Asia & co-located with the 3rd Probiotics Congress
05. Mär 2018 - 06. Mär 2018 • Singapore, Singapur
Zusammenfassung:
The 4th Microbiome R&D and Business Collaboration Congress: Asia will be held on March 5 – 6, 2018. It is co-located with the 3rd Probiotics Congress. Building on the success of the 2015, 2016 and 2017 meetings the event will bring well over 200 attendees from across the world to Singapore.
Kontakt:
saffuan kudus;     Tel.: [+60 3 21175247];     Email: saffuan@global-engage.com
Themen:
Microbiome, Probiotics, R&D, MICROBIOTA RESEARCH,
Eintrags-ID:
953120
Verwandte Fachgebiete:
10
Course - The Center for Professional Innovation & Education — FDA Inspections - What Regulators Expect and How to Prepare
05. Mär 2018 - 06. Mär 2018 • Los Angeles, CA, Vereinigte Staaten
Zusammenfassung:
This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
inspections, FDA
Eintrags-ID:
1013576
11
Course - The Center for Professional Innovation & Education — Process Validation for Drugs and Biologics
07. Mär 2018 - 08. Mär 2018 • Boston, MA, Vereinigte Staaten
Zusammenfassung:
The application of Process Validation is becoming an increasingly important activity for pharmaceutical and biotech organizations given the critical role validated processes have in ensuring product conformance. To assist industry, several guidances have been developed by regulatory agencies in the last few years that define the requirements and best practices for the effective implementation of Process Validation.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Process Validation, GHTF, Title 21,
Eintrags-ID:
1013564
12
Course - The Center for Professional Innovation & Education — Introduction to Molecular Biology Techniques
07. Mär 2018 - 09. Mär 2018 • Malvern, PA, Vereinigte Staaten
Zusammenfassung:
Molecular biology pertains to the study of living systems at the DNA, RNA, and protein levels, and how these molecules can be modified and harnessed for practical applications. Knowledge of the natural function of these molecules in the cell provides a context appropriate for further advancement in the rapidly expanding areas of functional genomics, cell biology, biotechnology, microbiology, diagnostics, therapeutics, and personalized medicine. This course, intended for the non-specialist, will focus on selected aspects of biotechnology in both basic- and applied research. In particular, the structural and functional relationships of molecular biology techniques to the biotech and pharmaceutical industries will be explained. Modern day molecular biology innovations and success stories will be presented and examples of molecular applications will be highlighted. At the end of the course, the participant will be conversant with respect to standard terminology in the field and will have an appreciation for the opportunities that exist within this discipline.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
DNA, RNA, proteins, Hybridization, Proteomics, PCR, SNPs, biomarkers, screening, RNAi, Stem Cells
Eintrags-ID:
1013552
13
Course - The Center for Professional Innovation & Education — Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy
07. Mär 2018 - 09. Mär 2018 • Los Angeles, CA, Vereinigte Staaten
Zusammenfassung:
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
root cause, 21 CFR, Deviation, Ishikawa, fault tree, CAPA,
Eintrags-ID:
1013617
14
The 3rd International Conference on Bioscience and Biotechnology
08. Mär 2018 - 09. Mär 2018 • Colombo, Sri Lanka
Zusammenfassung:
The 3 rd International Conference on Bioscience and Biotechnology to be held from 08 th -09 th  March 2018 in Colombo, Sri Lanka. Bio Tech 2018 will address a range of critically important areas in relation to Bioscience and Biotechnology under the theme “ Pursuing innovation in Bioscience and Biotechnology” Modern Biotechnology has advanced rapidly and has emerged as a potential science for providing benefits in all the fields of human welfare. It has a great impact in almost all the domains of human life, may it be health, environment, foods or agriculture. Recent advancements have led to a multidisciplinary applicability of biotechnology. Bio Tech 2018 will create a great platform to researches, scientists, academicians and industry experts to share experiences, discuss research findings and acquire the desired knowledge for practical exercise.
Eintrags-ID:
956532
15
Course — Particles in Biotherapeutics: Characterization & Impact (Part of Biotherapeutics Analytical Summit 2018)
12. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
This short course will give an introduction to current issues surrounding particle formation & characterization in biotherapeutics. Regulatory expectations provide the context of why particle loads are characterized and controlled. The basics of why and how proteins can aggregate will be presented along with a discussion of other particle types. An overview of the recent technology to accurately characterize various classes of aggregates and particles will be discussed. Studies from the current literature will be used to highlight various key points throughout the course.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989581
16
Course — The Multi-Attribute Method (MAM) for Improving Product and Process Development (Part of Biotherapeutics Analytical Summit 2018)
12. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
During biotherapeutic development, it is necessary to monitor properties of the therapeutic molecule and formulation that have been identified as critical quality attributes (CQAs) for product safety and efficacy. In particular, the industry is seeking to monitor post-translational modifications (PTMs), glycosylation profiles, and excipients with both UV and mass data by implementing multi-analyte or so-called Multi Attribute Methods (MAMs). The course offers hands-on training on how to apply the Multi-Attribute Method (MAM) to mass spectrometry data. We will be performing attribute analytics (quantifying product quality attributes) and new peak detection (purity test) on mass spec data. During the course, we will discuss the uses of the MAM in process development and in a QC lab.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989624
17
Method Development, Qualification & Validation (Part of Biotherapeutics Analytical Summit 2018)
12. Mär 2018 - 13. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
From method development to qualification to validation and transfer, it is a continuous yet inter-dependent process from early research to development to QC and release. Depending on which stage of product development you are in, your method may or may not need to be robust, qualified or validated. The objective is to prove that methods selected are fit for their intended purpose.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989587
18
Characterizing Aggregates & Impurities (Part of Biotherapeutics Analytical Summit 2018)
12. Mär 2018 - 13. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
Product and process-related impurities impact biopharmaceutical development at every stage from discovery to development to manufacturing. Detecting, identifying and characterizing these variants and impurities are of high regulatory concern, due to the potential correlation between aggregation and increased immunogenicity of the biotherapeutics.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989619
19
BES18 — BIO-Europe Spring® 2018 — 12th International Partnering Conference
12. Mär 2018 - 14. Mär 2018 • Amsterdam, Niederlande
Zusammenfassung:
The conference annually attracts the international “who’s who” from biotech, pharma and finance for three days of high caliber networking. BIO-Europe Spring’s world-class workshops, panels and active exhibition along with thousands of prescheduled one-to-one meetings make this event an unrivaled forum for companies across the biotech value chain to meet and do business. Attend BIO-Europe Spring and experience how you can have more partnering meetings in the three days of the conference than in the rest of the year.
Kontakt:
Catharine Moreno Finan;     Tel.: [+49 89 2388 756-25];     Email: cmoreno@ebdgroup.com
Themen:
partnering, business development, biotech, pharmaceutical, medical device, medtech, diagnostic, licensing, finance
Eintrags-ID:
1002962
20
BCC — Biotherapeutics Analytical Summit 2018
12. Mär 2018 - 16. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
The Biotherapeutics Analytical Summit, with its hallmark brand of topics on Method Development, Qualification & Validation, Advances in Characterization Methods & Approaches and Comparability & Biosimilarity, and its signature mix of regulators, industry and academia speakers, has come to be known as THE Analytical Summit where attendees can hear and learn about real-life case studies, innovative concepts and practical approaches that can help scientists advance their molecules from discovery to development and commercialization.
Kontakt:
Jason Gerardi;     Tel.: [781-972-5452];     Email: chi@healthtech.com
Themen:
Biotherapeutics, Method Development, Qualification, Validation, Characterization Methods, Characterization Approaches, Comparability & Biosimilarity
Eintrags-ID:
958906
21
Advances in Characterization Methods & Approaches (Part of Biotherapeutics Analytical Summit 2018)
13. Mär 2018 - 14. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
From early developability screening to assessing glycosylation and higher order structure, analytical techniques play an important role in identifying and characterizing the physico-chemical properties of the molecules, allowing scientists to better understand, control and optimize their molecules’ properties.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989552
22
Comparability & Biosimilarity (Part of Biotherapeutics Analytical Summit 2018)
13. Mär 2018 - 14. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
The 4th Annual Comparability and Biosimilarity conference continues to build upon the past years’ discussion on regulatory requirements and guidelines on comparability and biosimilarity assessments; analytical strategies and techniques to evaluate batch-to-batch comparability during process, site or manufacturing changes; equivalence testing of biosimilars with innovator products plus the use of mathematical modeling and statistical data to establish analytical biosimilarity; as well as strategies toward ICH harmonization in comparability and biosimilarity.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989628
23
Course — Core Principles and Best Practices for Biotech Analytical Test Methods across the Product Lifecycle (Part of Biotherapeutics Analytical Summit 2018)
13. Mär 2018 - 14. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
Current GMP requirements for test method validation are quite clear: Methods used for GMP product testing must be validated to demonstrate they can produce accurate and reliable results. But FDA and EU guidances are less clear about method ‘validation’ during product development. On the one hand, they indicate method validation is an evolving process, but on the other they state that method validation data should be available upon request at Phase II and Phase III. These guidances also indicate that test methods only need to be qualified for Phase I (except safety methods, which do require validation prior to Phase I). Methods used only for product or process characterization, comparability or similarity also need to be qualified to demonstrate they are scientifically sound. Some of these methods will start out in non-GMP labs then transfer to GMP labs; others will only ever be used in non-GMP labs. But during development, even data generated in non-GMP studies are critical for making process and product decisions, and are reported in product dossiers as supportive information. Although there is guidance on lab data integrity in GMP labs, there are no current guidance documents on data integrity in non-GMP labs.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989572
24
Course — Critical Quality Attributes and Testing Strategy for Biotherapeutics Development (Part of Biotherapeutics Analytical Summit 2018)
14. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
Biotherapuetics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. Identification of product critical quality attributes (CQAs) is an important component in the development of a robust control strategy using the Quality-by-Design approach. In this short course, we will discuss the key concepts of CQA risk ranking based on potential impact on safety and efficacy, defining control strategies, the common analytical characterization technologies used, and the considerations for development of an integrated testing strategy.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989689
25
Course — New Analytical Approaches & Strategies for Biosimilarity (Part of Biotherapeutics Analytical Summit 2018)
14. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
Providing convincing analytical similarity studies is a key success factors for the filing of biosimilars. For proper planning of novel or biosimilar development programs, it is important to understand the development costs, timelines and the authoring of CMC regulatory sections. The analytical characterization of comparability and similarity studies will form the cornerstone for each successful marketing authorization application of these products. This short course will focus on analytical development and its challenges, technical hurdles, BLA authoring, timelines and costs. Participants will be introduced to state-of-the art analytical similarity strategies, which anticipate occurrences of non-identity between biosimilar and originator, leading to a smooth and efficient IND/BLA application and approval.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989699
26
CfPIE - The Center for Professional Innovation & Education — Introduction to Medical Combination Products
14. Mär 2018 - 16. Mär 2018 • Berlin, Deutschland
Zusammenfassung:
This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction.
Kontakt:
Olivia Kane;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Combination Products, NDA, BLA, IND, Request for Designation, RFD Jurisdictional Decisions
Eintrags-ID:
1010036
27
CSS 2018 — Cool Supply System and Solution 2018
15. Mär 2018 - 16. Mär 2018 • Amsterdan, Niederlande
Zusammenfassung:
Voted as “the largest GDP Pharma Logistics Conference worldwide”, CSS is designed to give maximum interaction between the delegates and exhibitors.The multidisciplinary nature of the conference provides an opportunity to meet with decision makers from different fields including logistics, supply chain, distribution, packaging & labeling, quality and more… With GDP Inspectors, QPs and senior colleagues, CSS attracts an 84% Bio/Pharma Audience and 16% Service Solution Provider attendees.
Kontakt:
Jessica Dobson;     Tel.: [+44 (0) 207 096 1152];     Email: enquiry@cold-gdp.com
Themen:
Harmonising of GDP, subject to EEA as a reginal example, Technological advances in Total Supply Chain visibility based on global location and positioning, How can we make temperature mapping easier – for time & temperature controlled facilities & premises subject to GDP
Eintrags-ID:
1011844
28
Seminar — Regulatory Requirements across the Product Development Lifecycle (Part of Biotherapeutics Analytical Summit 2018)
15. Mär 2018 - 16. Mär 2018 • Baltimore, Vereinigte Staaten
Zusammenfassung:
The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: CHI@healthtech.com
Eintrags-ID:
989659
29
Undoing Aging
15. Mär 2018 - 18. Mär 2018 • Berlin, Deutschland
Zusammenfassung:
The 2018 Undoing Aging Conference is focused on the cellular and molecular repair of age-related damage as the basis of therapies to bring aging under full medical control. The conference provides a platform for the existing science community that already works on damage repair and at the same time offers interested scientists and students a first-hand understanding of the current state of this exciting new field of biomedical research. Speakers will include leading researchers from around the world focused on topics including stem cells, senescent cells, immunotherapies, biomarkers and drug discovery.
Themen:
biogerontology, aging, regenerative medicine, rejuvenation, senescent cells, stem cells, biomarkers, drug discovery
Eintrags-ID:
964736
Verwandte Fachgebiete:
30
Bio-inspired Materials — 4. Euro Bio-inspired Materials Konferenz
19. Mär 2018 - 22. Mär 2018 • Potsdam, Deutschland
Zusammenfassung:
Funktionelle Materialien und Systeme, deren Bildung, Struktur und Funktion auf Prinzipien aus der belebten Natur beruhen stehen im Fokus der nun zum vierten Mal in Potsdam stattfindenden internationalen Euro Bio-inspired Konferenz. Ein wesentliches Ziel der Veranstaltung ist es, ein internationales und interdisziplinäres Forum für Wissenschaftler aus verschiedenen Bereichen wie Biologie, Chemie, Materialwissenschaft und Ingenieurwesen, Physik und Medizin zu schaffen, um aktuelle Forschungsergebnisse zu diskutieren und zukünftige Forschungsrichtungen im Bereich bioinspirierter Materialien zu identifizieren. Betrachtet werden sollen zum einen natürlich vorkommende, biologische Materialien im Hinblick auf deren Bildung, komplexe hierarchische Struktur und Eigenschaften sowie Antriebsmechanismen und Bewegung von solchen Systemen. Zum anderen stellt die Übertragung von biologischen Prinzipien auf die Generierung von funktionellen Materialien und Systemen aus organischen und/oder anorganischen Komponenten einen weiteren Hauptgegenstand dieser Konferenz dar. In diesem Zusammenhang spielen neben der Materialsynthese und -bildung auch experimentelle und theoretische Studien zu den funktionellen und mechanischen Eigenschaften solcher Materialien eine Rolle. Die Konferenz umfasst auch medizinische Aspekte und Anwendungen von bioinspirierten Materialien, etwa im Hinblick auf deren Wechselwirkung mit Geweben und Organen.
Kontakt:
Tel.: [02241 2355449];     Email: bio-inspired@dgm.de
Themen:
functional materials, functional systems, biology, chemistry, materials science, engineering, physics, medicine, bioinspired materials, biological materials
Eintrags-ID:
1013507
31
BPDE — BioProcessing Summit Europe 2018
20. Mär 2018 - 22. Mär 2018 • Lissabon, Portugal
Zusammenfassung:
Bioprocessing Summit Europe brings together leading bioprocessing scientists to share day-to-day challenges and practical solutions for today's bioprocessing needs. Created by the producers of PEGS, PepTalk and The Bioprocessing Summit Boston, this four-conference, scientifically driven event presents detailed case studies, technology updates, and best practice in cell culture, scale-up, recovery, purification, continuous manufacturing, process intensification, and bioproduction. Along with the impressive array of conferences, the Summit also features Short Courses, interactive Breakout Sessions and an extensive Exhibit Hall to provide in-depth coverage of critical bioprocess topics.
Kontakt:
Sherry Johnson (Companies A-K), Carolyn Benton (L-Z);     Tel.: [781.972.5400];     Email: chi@healthtech.com
Themen:
bioprocessing
Eintrags-ID:
958896
32
Controlled Release Delivery 2018 — 15th Controlled Release Delivery Conference
21. Mär 2018 - 22. Mär 2018 • London, Großbritannien
Zusammenfassung:
Building on the success of previous events, SMi's Controlled Release Delivery conference returns for its 15th year in London on 21-22 March 2018. Featuring presentations to analyse and evaluate latest advancements in drug delivery, this year's event highlights include the formulation of Controlled Release Delivery Technologies and improving the design of new controlled release delivery systems; Innovative additions to Oral Controlled Release Delivery Technologies, to improve the pharmacokinetic-pharmacodynamic properties of the drug; latest regulation guidance and their implications for the pharmaceutical industry; Clinical developments and lessons learnt during clinical trials, through case studies with top pharmaceutical companies and more.
Kontakt:
Honey de Gracia;     Tel.: [+44(0)2078276102];     Email: hdegracia@smi-online.co.uk
Themen:
controlled release, controlled release delivery, controlled release delivery system, delayed release, extended release, substained release, oral controlled release, drug delivery, modified release, pharmacokinetics, pharmacodynamics, drug regulation, clinical trials, oral controlled release, clinical drug trial
Eintrags-ID:
964034
33
International Pharmaceutical Conference and Expo
21. Mär 2018 - 23. Mär 2018 • Philadelphia, Vereinigte Staaten
Zusammenfassung:
International Pharmaceutical Conference and Expo (iPharma 2018) cordially welcomes you to the City of Philadelphia, USA during March 21-23, 2018. Conference will witness academicians and business professionals discussing the soundest issues related to pharmaceuticals and will offer unparalleled business opportunities and access to new markets in Pharma, Medical and Health Care Industry.
Kontakt:
Serena Mastin;     Tel.: [(619) 378-4793];     Email: serena@ipharmaconference.com
Themen:
Conference sessions include but not limited to: Pharmaceutics, Drug Discovery, Drug Delivery Systems, Drug Designing, Neuropharmacology, Drug therapy, Pharmacogenomics, Pharmacovigilance, Biopharmaceuticals, Nutraceuticals, Drug Development, Pharmaceutical Manufacturing, Quality Risk Management, Generic Drugs, Orphan Drugs, Clinical trials, Regulatory affairs, Drug formulations, Green Chemistry, Molecular Diagnostic, Separation Techniques and more.
Eintrags-ID:
938378
34
5th Plant Genomics and Gene Editing Congress: Asia
26. Mär 2018 - 27. Mär 2018 • Bangkok, Thailand
Zusammenfassung:
The 5th Plant Genomics and Gene Editing Asia Congress will be held on the 26th and 27th of March 2018. In 2018 the meeting is moving to in Bangkok and will focus on the differing needs and circumstances of plant genomics and researchers across the Asia Pacific. In addition to focusing on the science and research to improve crops, the challenges & opportunities presented by urbanization, international trade, climate change and healthcare are also examined. It will also feature essential researchers on genome editing, crop trait development, epigenetics, phenotyping, plant microbiome and disease resistance breakthroughs for models crops such as rice, wheat, palm oil, canola and much more.
Kontakt:
saffuan kudus;     Tel.: [+60 3 21175247];     Email: saffuan@global-engage.com
Themen:
Plant Genomics, Gene Editing, crop trait development, epigenetics, phenotyping, plant microbiome and disease resistance
Eintrags-ID:
953163
Verwandte Fachgebiete:
35
CfPIE - The Center for Professional Innovation & Education — Biostatistics for Non-Statisticians
26. Mär 2018 - 28. Mär 2018 • Berlin, Deutschland
Zusammenfassung:
The first two days of this course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical environment. The first day will emphasize the principles of descriptive and inferential statistical applications while the second day will focus on actual study examples, problem solving and interpretation of clinical (efficacy and adverse events) results. Throughout the course, participants are encouraged to ask questions and discuss examples relevant to their own work.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
statistical concepts, statistical applications, sample size, regression, Survival analysis, meta-analysis, statistical principles
Eintrags-ID:
1009997
Verwandte Fachgebiete:
36
CfPIE - The Center for Professional Innovation & Education, Inc. — The Drug Development Process – From Discovery to Commercialization
26. Mär 2018 - 28. Mär 2018 • Berlin, Deutschland
Zusammenfassung:
The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Drug discovery, Development, Non-Clinical Studies, Clinical Studies, Post Approval
Eintrags-ID:
1010006
37
Keystone Symposia: Organs- and Tissues-on-Chips
08. Apr 2018 - 12. Apr 2018 • Big Sky, Montana, Vereinigte Staaten
Zusammenfassung:
More than 30% of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in 2-D cell culture and animal models. Another 60% fail due to lack of efficacy. Consequently, though several thousand diseases affect humans, only about 500 have approved treatments. However, with the growing understanding of human biology, along with increased availability of innovative technologies, there is now an unprecedented opportunity to translate scientific discoveries more efficiently into new, more effective and safer health interventions. Organs- or Tissues-on-Chips are innovative, alternative approaches that would enable early indications and potentially more reliable readouts of toxicity and efficacy. These microfabricated devices recapitulate the multicellular architectures, tissue-tissue interfaces, physicochemical microenvironments, vascular perfusion and innervation, producing in essence microphysiological systems that mimic human tissue and organ functionality not possible with conventional 2D or 3D culture systems. Through innovative biosensing and readout approaches, these devices employ high-resolution, real-time imaging and non-invasive analysis of biochemical, genetic and metabolic activities of living cells in a functional tissue and organ context. This technology has great potential to advance the study of tissue development, organ physiology and disease etiology. In the context of drug discovery and development, it should be especially valuable for the study of molecular mechanisms of action, prioritization of lead candidates, toxicity testing and biomarker identification. These microfabricated devices have also proven to be useful for modeling human diseases. This conference will touch on ongoing efforts and various applications of tissue-on-chips technology to studies in precision medicine, environmental exposures, reproduction and development, cancer and for use at the International Space Station.
Kontakt:
Attendee Services;     Tel.: [970.262.1230];     Email: info@keystonesymposia.org
Themen:
nanotechnology, biotechnology, biosensing, tissue development, organ physiology, disease etiology, drug discovery and development
Eintrags-ID:
948440
38
Les journées Internationales d’Information sur les: Phytoressources Aquatiques & terrestres
09. Apr 2018 - 10. Apr 2018 • Monastir, Tunesien
39
CfPIE - The Center for Professional Innovation & Education, Inc. — Computer System Validation
12. Apr 2018 - 13. Apr 2018 • Berlin, Deutschland
Zusammenfassung:
This computer system validation course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
21 CFR part 11, computer validation, GAMP 5, Auditing GXP, Part 810, Part 211, Q7A GMPs, Software Validation
Eintrags-ID:
1009994
40
AiB 2018 — Advances in BioPhotonics 2018
18. Apr 2018 • London, Großbritannien
Zusammenfassung:
Significant advances in photonics are leading to an ever increasing role in the biomedical, chemical and life sciences, in medicine, clinical sciences, neurophysiology etc. In particular there is increasing awareness of the potential for solving health challenges in Africa and other low income countries.
Kontakt:
Laurence Devereux;     Tel.: [+44 1372 750555];     Email: info@xmarkmedia.com
Themen:
3D microscopy, Advanced microscopy including fluorescence & multiphoton, Clinical Raman, Fluorescence lifetime tomography, FRET & super resolution imaging, Global Health, Lab on a chip, Live-cell, non-invasive imaging, Optical biosensing, Optical coherence tomography, Optical trapping and manipulation, Optogenetics, Point of care diagnostics, Surface plasmon resonance imaging, Two-photon imaging
Eintrags-ID:
1010219
Verwandte Fachgebiete:
41
CRISPR — 3 DAY TRAINING COURSE IN NEXT GENERATION SEQUENCING DATA ANALYSIS AND CRISPR/Cas9
18. Apr 2018 - 20. Apr 2018 • Dubai, Vereinigte Arabische Emirate
Zusammenfassung:
The program will be conducted for 3 days for which participants have to bring their own laptop for which the Linux environment will be provided by us so that they can use that for running training processes on their laptops. We will provide handouts (soft & hard copy both) along with the software and paper of technology. It will be extensive training program which will make the participants do all the processes on their Computer Systems (hands-on training) with complete learning of this latest technology.The course will be of great help to students/ researchers/ faculty/ scientists in learning this latest science and technology.
Kontakt:
Rishabh Shukla;     Tel.: [+919538710056];     Email: workshops@biodiscoverygroup.com
Themen:
gene_editing, genome_editing, crispr, cas9, dna_sequencing, ngs, rnaseq, biotechnology, biotech, bioinfo, bioinformatics, genomics, genome, dna
Eintrags-ID:
983039
Verwandte Fachgebiete:
42
CfPIE - The Center for Professional Innovation & Education — Good Manufacturing Practices Training | GMP Course
18. Apr 2018 - 20. Apr 2018 • Berlin, Deutschland
Zusammenfassung:
This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
GMP, Change Control, Master Plan, Laboratory Controls
Eintrags-ID:
1010015
43
CfPIE - The Center for Professional Innovation & Education — QbD: Product and Process Optimization using Design of Experiments
23. Apr 2018 - 25. Apr 2018 • Berlin, Deutschland
Zusammenfassung:
CQuality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables to perform the necessary experiments in an efficient and structured way. This constitutes the most effective manner to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) that, together, influence most the quality characteristics of highest concern, the so-called Critical Quality Attributes (CQA’s). Of course, the methodology can also be applied to optimize existing products or processes.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Quality by Design, Factor screening and modelling, DoE, Critical Process Parameters (CPP’s), Critical Material Attributes (CMA’s)
Eintrags-ID:
1009980
44
CBPF18 — ChinaBio® Partnering Forum 2018
25. Apr 2018 - 26. Apr 2018 • Suzhou, China
Zusammenfassung:
Access a world of opportunities through life science partnering in China. ChinaBio® Partnering Forum is the premier life science partnering event in China. The conference will be held April 25–26 in Suzhou, attracting biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering.
Kontakt:
Philipp Dormeier;     Tel.: [+49 89 2388 756-42];     Email: pdormeier@ebdgroup.com
Themen:
partnering, business development, biotech, pharmaceutical, medical device, diagnostic, licensing, finance, China, life science, cross border
Eintrags-ID:
1004360
45
Biotech-2018 — International Biotechnology and Research Conference
25. Apr 2018 - 27. Apr 2018 • Rom, Italien
Zusammenfassung:
International Biotechnology and Research Conference (Biotech-2018) is going to be held during April 25-27, 2018 at Rome, Italy. Biotech-2018 bring upon a new platform to share and discuss all the innovations in the Biotechnology and its allied areas. BIOTECH 2018 will create a great platform to researches, scientists, academicians and industry experts to share experiences discuss research findings and it provides an opportunity to explore the innovative ideas to acquire the desired knowledge for practical exercise.
Kontakt:
Rajeshwar;     Tel.: [+1-302-231-6959];     Email: biotech@madridge.com
Eintrags-ID:
973548
46
Biotech-2018 — International Biotechnology Conference
25. Apr 2018 - 27. Apr 2018 • Rom, Vereinigte Staaten
Zusammenfassung:
International Biotechnology Conference will be held during April 25-27, 2018 at Rome, Italy. Biotech-2018 brings upon a new platform to share and discuss all the innovations in the field of Biotechnology and its allied areas. Biotech-2018 will focus on most recent progressions and technologies in this field. This conference is a gathering of all eminent persons, scientists and professors of biotechnology from all over world.
Kontakt:
Santosh MJ;     Tel.: [3022316959];     Email: biotech@madridge.com
Themen:
Food Biotechnology, Cell and Molecular Biology, Applied Biochemistry
Eintrags-ID:
916077
47
International Biotechnology Conference
25. Apr 2018 - 27. Apr 2018 • USA, Vereinigte Staaten
Zusammenfassung:
International Biotechnology Conference will be held during April 25-27, 2018 at Rome, Italy. Biotech-2018 brings upon a new platform to share and discuss all the innovations in the field of Biotechnology and its allied areas.  Biotech-2018 will focus on most recent progressions and technologies in this field. This conference is a gathering of all eminent persons, scientists and professors of biotechnology from all over world.
Eintrags-ID:
937799
48
CRISPR & NGS — 3 DAY TRAINING COURSE IN NEXT GENERATION SEQUENCING DATA ANALYSIS AND CRISPR/Cas9
01. Mai 2018 - 03. Mai 2018 • Bangkok, Thailand
Zusammenfassung:
The program will be conducted for 3 days for which participants have to bring their own laptop for which the Linux environment will be provided by us so that they can use that for running training processes on their laptops. We will provide handouts (soft & hard copy both) along with the software and paper of technology. It will be extensive training program which will make the participants do all the processes on their Computer Systems (hands-on training) with complete learning of this latest technology.The course will be of great help to students/ researchers/ faculty/ scientists in learning this latest science and technology.
Kontakt:
Rishabh Shukla;     Tel.: [+919538710056];     Email: workshops@biodiscoverygroup.com
Themen:
gene_editing, genome_editing, crispr, cas9, dna_sequencing, ngs, rnaseq, biotechnology, biotech, bioinfo, bioinformatics, genomics, genome, dna, rna, transcriptomics
Eintrags-ID:
984101
49
CTL — Clinical Trial Innovation Summit 2018
07. Mai 2018 - 09. Mai 2018 • Boston, Vereinigte Staaten
Zusammenfassung:
New Technologies, Analytics, Quality Measures and Improved Partnerships for Clinical Trials of the Future: Cambridge Healthtech Institute's Clinical Trial Innovation Summit brings together 250 leaders from across pharma, biotech and academia for the perfect blend of high quality presentations and intimate networking. Through case studies, interactive discussions and an active exhibit hall, the summit delivers the real-world experiences and best practices needed to optimize clinical trial management. Presentations span across the most complex areas of trial management, including patient recruitment, site selection, data integration, leveraging existing data sources, mobile technologies, project management, outsourcing, vendor management, budgeting and contracting, quality (QbD) in trial conduct and risk-based monitoring.
Kontakt:
Cambridge Healthtech Institute;     Tel.: [781.972.5400];     Email: chi@healthtech.com
Themen:
technologies, analytics, quality measures, improved partnerships, clinical trials, life sciences, biotech, biotechnology, pharma
Eintrags-ID:
1015909
Verwandte Fachgebiete:
50
2nd edition of the International Symposium of Young Researchers in Biology
11. Mai 2018 - 14. Mai 2018 • Hammamet, Tunesien
Zusammenfassung:
After the big success of the first edition, the 2018 Symposium will confirm the main goal of the YTRB organization, the young Tunisian scientist network. The event will constitute a real opportunity for young scientist to create a new network and establish collaboration between young and future researchers in Tunisia and all over the world. This newest and unique scientific event in Tunisia is a meeting point for academic scientists, biologists, pharmacists and industrials that share a new and exciting vision of science. The symposium is an opportunity for cooperation and technology-exchange with excellent young group leaders in fundamental and applied research. Tunisian and international young eminent specialists will give talks in the following sessions,Biotechnology, Genomics and Bioinformatics, and Molecular/Cell Biology and Immunology.
Kontakt:
Mohamed JEMAA;     Email: jemaamohamed@gmail.com
Themen:
​- Biotechnology: Microbiology, Toxicology, Plant molecular physiology, Plant biotechnology, Enzymology, Micro/Macornutrients, Food technology and Processing, Nanotechnology - Genomics and Bioinformatics: Linkage analysis, Genomics engineering, Human genetics, Gene mapping, Next generation sequencing, Molecular modeling, Epigenetics, pharmacogenomics ​- Molecular/Cell Biology and Immunology: Molecular/Cellular biology, Biochemistry, Development, Stem cells, Oncology, Immunology, Immunotherapy, Cell signaling, Cell physiology, Clinical research
Eintrags-ID:
923054
Verwandte Fachgebiete:
51
6th Plant Genomics and Gene Editing Congress: Europe
14. Mai 2018 - 15. Mai 2018 • Rotterdam, Niederlande
Zusammenfassung:
Attracting experts working in all areas of plant science, the event will examine the latest in gene editing methods as well as exploring developments in NGS and omic technologies being used for progressing plant based research in aspects such as crop trait development, epigenetics, phenotyping, plant microbiome, and disease resistance as well understanding tools to overcome bottlenecks and enable successful data analysis and management.
Kontakt:
Jane Williams;     Tel.: [01865 849841];     Email: jane@globalengage.co.uk
Themen:
plant genomics, gene editing, omics, NGS, microbiome, bioinformatics
Eintrags-ID:
953010
Verwandte Fachgebiete:
52
Project & Portfolio Management for Pharma and Biotech Summit
22. Mai 2018 - 23. Mai 2018 • Philadelphia, Vereinigte Staaten
Zusammenfassung:
Linking strategy to execution and proactively managing variance
Kontakt:
Héctor Bedoya;     Tel.: [+421 257 272 164];     Email: event.inquiries@fleming.events
Themen:
project, portfolio, management, pharma, biotech, summit, dynamics of high-performing, cross-functional, global, team, change program, GSK, innovation process, fleming, philadelphia, united states
Eintrags-ID:
1003368
53
CfPIE - The Center for Professional Innovation & Education — CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
23. Mai 2018 - 25. Mai 2018 • Berlin, Deutschland
Zusammenfassung:
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with the strategic ICH Q8/Q9/Q10 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
compliance, biologics, FDA, EMA, regulatory review pathways, IND, NDA, BLA, MAA
Eintrags-ID:
1009985
54
#Medbiotech18 — Medical Biotechnology
24. Mai 2018 - 25. Mai 2018 • Gent, Belgien
Zusammenfassung:
With this conference on Medical Biotechnology VIB will bring together experts in the field to discuss the new developments and future challenges in this field.
Kontakt:
VIB Conferences;     Tel.: [+32 9 244 66 11];     Email: conferences@vib.be
Themen:
biopharmaceutical, biopharma, biotherapeutics, targeted delivery, targeted therapeutics, diagnostics, biomarkers, vaccines, development of vaccines, vaccine development, experimental vaccines, novel vaccines, RNA-based cancer vaccines, diagnostic tools, biobetters, therapeutic antibodies, biomolecular, personalized medicine, drug discovery, therapeutic application, next-generation biologics, viral growth and purification, antiviral immunity, Medical biotechnolgy, Biopharmaceutical technology, Vaccine development, Diagnostics, Medical Biomarkers
Eintrags-ID:
989557
55
BDRC 2018 — Biomarkers - From Research To Commercialization
25. Mai 2018 - 26. Mai 2018 • Bengaluru, Indien
Zusammenfassung:
After the successful 2017 event 'Biosensors, Biomarkers & Diagnostics - From Research to Commercialization' SELECTBIO presents to you "Biomarkers & Diagnostics - From Research to Commercialization" in Bengaluru, India. This conference will bring together scientists to discuss advancements in biomarkers and other molecular approaches involved in the prognosis and diagnosis of diseases and leading to development of a novel diagnostic test.
Kontakt:
Jatin Kashyap;     Tel.: [8289015050];     Email: sb.jatinkashyap@gmail.com
Themen:
Advanced Approaches & Techniques in Disease Diagnosis, Case Studies - From Biomarkers Research to Commercial Product, Commercial Aspects & Regulatory Compliance in Molecular Diagnostics, Extracellular Biomarkers/Cell Free Biomarkers, Novel Biosensors for Medical Diagnostics, Prognostic, Predictive and POC: Biomarkers from Research to Clinic,
Eintrags-ID:
977691
56
CfPIE - The Center for Professional Innovation & Education — Preparing the CMC Section for MAAs, IMPDs
30. Mai 2018 - 31. Mai 2018 • Berlin, Deutschland
Zusammenfassung:
This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
MAA, CTD, drug substance, purity, stability, DMF, Certificates of Suitability, CEP, CMC, chemistry manufacturing and controls
Eintrags-ID:
1010012
57
CMS3 Summer School — Advanced Topics on Cell Model System
04. Jun 2018 - 08. Jun 2018 • Rom, Italien
Zusammenfassung:
The purpose of the CMS3 Summer School is integrating interdisciplinary training that allows students to develop skills and knowledge in a range of subjects, specifically in the field of models of cell, biomaterials, tissue engineering and molecular dynamic simulation. Eleven scientists of the Research Establishment based at Rome-Tor Vergata will organize this School. This Research Establishment, with its unique set of advanced instrumentation and technologies, provides a strong technical infrastructure for the School. It combines world-class advanced sensors; precise analytical methods; enhanced imaging capabilities, and sophisticated computational tools for characterizing and modelling cells. Top level equipment and instrumentation will be available at Research Establishment of CNR based at Rome-Tor Vergata for practical training on: i) membrane model systems and protocell, ii) biosensors and micorelectronics, ii) dynamic molecular simulation. During the course target group of pprox.15-18 PhD and post-doc students from all over World will brought together. Thirteen outstanding scientists will be invited to come over for the lectures and discuss their work from different countries: Germany, Israel, Italy, United Kingdom and Switzerland.
Kontakt:
Email: cms3.cnr@gmail.com
Themen:
Cell model systems, Biophysics, Pharmacology, Imaging, Bio-sensors, Computational thinking, Educational
Eintrags-ID:
1000828
58
3rd Functional DNA Nanotechnology Workshop
06. Jun 2018 - 08. Jun 2018 • Rom, Italien
Kontakt:
Email: info@fdn2018.com
Themen:
Functional DNA nanotechnology (nanostructures, DNA origami, etc); Bioengineering; Synthetic biology; DNA-based sensing; Aptamer; DNA-peptide chimera
Eintrags-ID:
948664
Verwandte Fachgebiete:
59
9th Annual Biologics Formulation Development and Drug Delivery Forum
06. Jun 2018 - 08. Jun 2018 • Amsterdam, Niederlande
Zusammenfassung:
This marcus evans forum will feature these existing key problems confronting formulation scientists and assist them with a better experiment protocol to ensure quality processes aligned with health authorities requirements, robust and rational methodology to minimise failure risks. The delegates will benefit from experienced case study and understand how to improve formulation stability, preventing aggregation, develop high-concentration forms; they will also learn how to use predictive and analytical methods in order to understand the behaviour and evolution of proteins under different stresses and help scientists characterising proteins and different components of the formulation. They will also apprehend the manufacturing and scale up challenges, looking at compatibility problems, lyophilisation issues, and consider the different possibilities offered for drug delivery, keeping in mind the crucial need for improving comfort and safety to patient.
Kontakt:
Constandinos Vinall;     Tel.: [0035722849380];     Email: Constandinosv@marcusevanscy.com
Themen:
Improve the design of biological formulation with automated and high-throughput solutions, Integrate QbD processes in biological drug development, Enhance stability process controlling aggregation, Improve characterization with efficient analytical tools, Discuss the regulatory environment around biological drug development
Eintrags-ID:
1013454
60
2nd Annual Microbiome Discovery and Development Congress
07. Jun 2018 - 08. Jun 2018 • Berlin, Deutschland
Zusammenfassung:
Oxford Global is proud to present the 2nd Annual Microbiome Discovery and Development Congress, taking place on the 7-8th June 2018 in Berlin, Germany. The conference showcases world-class senior industry experts presenting case studies on the most exciting issues in the microbiome field, covering novel strategies in microbiome research, the latest therapeutic trends, and the challenges and opportunities involved in commercialising microbiome therapeutics.
Kontakt:
Guillaume Alonso;     Tel.: [+44 (0)1865 250985];     Email: g.alonso@oxfordglobal.co.uk
Themen:
new technologies for microbiome drug discovery, development and commercialisation of microbiome therapeutics, novel strategies & technologies for Microbiome Drug Discovery, therapeutic potential of the microbiome
Eintrags-ID:
999980
61
Pharmaceutical Microbiology West Coast
07. Jun 2018 - 08. Jun 2018 • San Diego, Kalifornien, Vereinigte Staaten
Zusammenfassung:
SMi proudly presents the 2nd Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on the 7th and 8th of June 2018. The pharmaceutical microbiology field is an ever-present constant in almost all areas of pharmaceuticals. Therefore, professionals within the field need to be informed and updated on the revised regulations and newly emerging methods and practices.
Kontakt:
Simi Sapal - Marketing;     Tel.: [+44(0) 207 827 6162];     Email: ssapal@smi-online.co.uk
Themen:
Pharmaceutical, microbiology, contamination, microbial, biofilms, sterility, quality assurance, mycoplasma, data integrity, microbiome, Bacteria, microbiota, metagenome, microorganisms, aseptic, organisms, biotech, quality control, quality assurance, antibiotics, pathogenic, diseases, bacteria, protozoal parasites, viruses, fungi, biotechnology, genetic engineering, vaccines, dna, sterility, sterile, sterilization, environmental monitoring, rapid, RMM, contamination, endotoxins, pyrogen, contaminants, aseptic, cleanroom, bacterial, decontamination, peroxide, hydrogen, decontamination, enzyme, endoxtins, sanitization, remediation, fungal, mycoplasma, sterile, aseptic, mycology, medical device
Eintrags-ID:
1005886
62
Biohydrometallurgy '18
11. Jun 2018 - 13. Jun 2018 • Windhoek, Namibia
Zusammenfassung:
This, the 9th International Symposium on Biohydrometallurgy (Biohydromet '18), is organised by MEI with Prof Sue Harrison, Dr Patrick d'Hugues and Dr Chris Bryan. Biohydromet '18 will focus on the latest developments in the field of biohydrometallurgy: the development, optimisation and application of integrated biomining process operations for mineral ores, including low grade and complex ores; the microbiology of biomining and the application of biohydrometallurgy to novel resources (such as mine and electronic wastes) and the (bio)remediation of mining-impacted environments.
Kontakt:
Dr Barry Wills;     Email: bwills@min-eng.com
Themen:
minerals, processing, mining, hydrometallurgy, biohydrometallurgy, extractive, metallurgy, biomining, bioleaching, bioremediation, microbiology, biooxidation
Eintrags-ID:
854939
Verwandte Fachgebiete:
63
Biotech France 2018 Conference and Exhibition
27. Jun 2018 - 29. Jun 2018 • Paris, Frankreich
Zusammenfassung:
The Biotech France 2018 program will present the most advanced issues in biotechnology and its related fields which will be discussed by a selected group of international scientists, Industrials and Investors. It will include the research, industrial and commercial aspects of biotechnology, in areas such as: Healthcare and Pharmaceuticals, Food and Agriculture, Biofuels, Environment and Biodiversity, Biocatalysis, Bioremediation, Process engineering, etc.
Kontakt:
Mr. Ben Madhi;     Tel.: [+33645574009];     Email: info@setcor.org
Themen:
Advancements in Biotechnology, Bioengineering and Biotechnology, Biomass and Bioenergy, Bioremediation and Biodegradation, Biotechnology and Bioprocess Engineering, Environmental Biotechnology, Genetic Engineering and rDNA Technology, Biotechnology conference, Biotechnology conference Paris, Biotechnology conference France, Molecular Biology & Bio-Chemistry, Microbial Biotechnology, Industrial Biotechnology, Nanobiotechnology, Bioengineering, Pharmaceutical/ Medical Biotechnology, Cell & Molecular Biology and BioInformatics, Food, Marine and Agro-Biotechnology, Physiology/Biochemistry, Biochemical Engineering/Bioprocess Engineering, Industrial Processes/New Products
Eintrags-ID:
977852
64
Gordon Research Conference — Drug Metabolism
08. Jul 2018 - 13. Jul 2018 • Holderness School, Holderness, NH, Vereinigte Staaten
Zusammenfassung:
The 48th Drug Metabolism Gordon Research Conference will focus on cutting edge research in drug ADME (absorption, distribution, metabolism, elimination), encompassing a wide range of research from the cellular level to the patient. Complexity in biological systems and enzymatic processes is continually uncovered in science. The conference aims to illuminate this biological complexity, often studied with simple biological and mathematical models, in order to enhance the application of new knowledge to understanding drug safety and efficacy in the clinic.
Eintrags-ID:
953766
65
SSBSS 2018 — 5th International Synthetic & Systems Biology Summer School
25. Jul 2018 - 29. Jul 2018 • Certosa di Pontignano (Siena) Tuscany, Italien
Zusammenfassung:
The Synthetic and Systems Biology Summer School (SSBSS) is a full-immersion five-day residential summer school at the Certosa di Pontignano (Siena – Tuscany, Italy) on cutting-edge advances in systems and synthetic biology with lectures delivered by world-renowned experts. The school provides a stimulating environment for students (from Master students to PhD students), Post-Docs, early career researches, academics and industry leaders. Participants will also have the chance to present their results, and to interact with their peers, in a friendly and constructive environment.
Kontakt:
SSBSS 2018 Organizing Committee;     Email: ssbss@icas.xyz
Themen:
Computational Synthetic Biology, Genetic Engineering, Metabolic Engineering, Reading and Writing Genomes, Synthetic Genomes, Synthetic Circuits and Cells, Artificial Tissues and Organs, Genomically Recoded Organisms, Genome Design, Biological Design Automation and Biological CAD, Computational Systems Biology, Genome Engineering, Quantitative Molecular Biology, High-throughput Techniques, Biological Engineering, Industrial Synthetic and Systems Biology
Eintrags-ID:
977085
66
Gordon Research Seminar — Drug Carriers in Medicine and Biology
11. Aug 2018 - 12. Aug 2018 • Mount Snow, West Dover, VT, Vereinigte Staaten
Zusammenfassung:
The 2018 Gordon Research Seminar on Drug Carriers in Medicine and Biology is the third biennial forum for young researchers to present data and exchange ideas in the areas of materials, immunology, and drug delivery. The Drug Carriers GRS provides a platform for graduate students, post-docs, and biotech/pharmaceutical professionals to build a scientific network in an informal setting designed to facilitate scientific discussions and idea generation.
Eintrags-ID:
953789
67
18th International Biotechnology Symposium and Exhibition
12. Aug 2018 - 17. Aug 2018 • Montréal, Kanada
Eintrags-ID:
990456
Verwandte Fachgebiete:
68
Gordon Research Conference — Drug Carriers in Medicine and Biology
12. Aug 2018 - 17. Aug 2018 • Mount Snow, West Dover, VT, Vereinigte Staaten
69
GPCRs 2018 — 7th RSC / SCI symposium on GPCRs in Medicinal Chemistry
10. Sep 2018 - 12. Sep 2018 • Verona, Italien
Zusammenfassung:
The key role of G protein-coupled receptors (GPCRs) in human disease underpins their importance to modern medicine. We are pleased to announce that Aptuit, Italy will support the seventh meeting in this series on GPCR drug discovery, which will combine cutting edge medicinal chemistry with innovative structural biology and novel drug design approaches.
Kontakt:
Mrs Maggi Churchouse;     Tel.: [+44 (0)1359 221004];     Email: maggi@maggichurchouseevents.co.uk
Themen:
GPCRs, G protein-coupled receptors, drug discovery, biological chemistry, medicinal chemistry, structural biology, drug design
Eintrags-ID:
1006133
70
Enzymology 2018 — 4th International Conference on Enzymology and Lipid Science
11. Sep 2018 - 12. Sep 2018 • Singapore, Singapur
Zusammenfassung:
International Conference on Enzymology and Lipid Science is going to be held during September 11-12, 2018 in Singapore’s capital city Singapore. The conference focuses on foremost topics such as Enzymology & Biochemistry, Clinical Enzymology, Enzyme Kinetics, Enzymology in Drug Discovery, Industrial Applications of Enzymology, Lipids in Molecular Medicine, Protein-Lipid & Lipid- Lipid Interactions and Lipids: Nutrition and Health.
Kontakt:
Clara Jones;     Tel.: [1-702-508-5200 Ext:6028];     Email: enzymology@annualcongress.net
Themen:
Enzymology Congress 2018, Enzymology conferences 2018, Enzymology workshops, Molecular Enzymology, Clinical, Group Registrations, Enzymology Singapore, Lipoprotein Metabolism, Enzymology, Proteomics, Computational Enzymology, Enzymology 2018.
Eintrags-ID:
927823
71
Course — European Regulatory Procedures - EMA & National Requirements
13. Sep 2018 - 14. Sep 2018 • Berlin, Deutschland
Zusammenfassung:
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Eintrags-ID:
1012428
72
Course — Technical Writing for Pharma, Biotech and Med Devices
26. Sep 2018 - 28. Sep 2018 • Berlin, Deutschland
Zusammenfassung:
This medical writing course’s notes and interactive exercises address how to write effective correspondence and reports in support of the company's activities. You will learn how to organize and deliver information for the intended audience, as well as how to write clear and readable documents, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
medical writing, Language,
Eintrags-ID:
1012437
73
Macrocycles 2018: 3rd RSC BMCS Medicinal Chemistry Symposium on Macrocycles
08. Okt 2018 - 09. Okt 2018 • Stevenage, Großbritannien
Zusammenfassung:
The objective of this symposium is to promote scientific interaction between scientists with a shared interest in the field of Macrocycles. This area is responsible for a growing number of therapeutic approaches and development candidates, all of which go ‘beyond the rule-of–five’. As a researcher in this field, come along to hear about the latest advances and also to share in some of the secrets of discovering therapeutic agents which go beyond Lipinski’s rules.
Kontakt:
Mrs Maggi Churchouse;     Tel.: [+44 (0)1359 221004];     Email: maggi@maggichurchouseevents.co.uk
Themen:
Macrocycles, medicinal chemistry, biological chemistry, drug discovery, Lipinski’s rules, therapeutic approaches
Eintrags-ID:
1006164
74
Course — ADME, PK/TK & Drug Metabolism in Drug Discovery and Development
09. Okt 2018 - 11. Okt 2018 • Berlin, Deutschland
Zusammenfassung:
This pharmaceutical manufacturing training course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed. Study designs and potential results along with possible interpretations from each of the study types will be presented. The generation study reports and summaries, both of which are to be included in submissions to regulatory authorities for completed research experiments, will also be discussed.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
ADME, Toxicokinetics, Drug Metabolism, Metabolite Isolation, Pharmacokinetic, PK/TK
Eintrags-ID:
1012381
75
Course — Auditing and Qualifying Suppliers and Vendors
15. Okt 2018 - 16. Okt 2018 • Berlin, Deutschland
Zusammenfassung:
The auditing and qualifying training course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact (risk) to the final product. Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. Initially, the course will discuss the regulatory expectations and other industrial references/ standards that will impact your system and will include the general requirements of a vendor/supplier (outsourcing) control program followed by specific requirements for different types of supplied materials/equipment/services.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
outsourcing, audits, supplier, vendor, QC, change control, equipment, Calibrations, Laboratories, Maintenance
Eintrags-ID:
1012479
76
ICBEB 2018 — The 7th International Conference on Biomedical Engineering and Biotechnology
17. Okt 2018 - 20. Okt 2018 • Nanjing, China
Zusammenfassung:
The 7th International Conference on Biomedical Engineering and Biotechnology (ICBEB 2018) will be held from 17th to 20th, 2018 in Nanjing, China. Hosted by the Southeast University & Nanjing Medical University, ICBEB 2018 aims to provide a forum for prestigious specialists and scholars to share their experiences and demonstrate frontier research results in the related fields, including Biomechanics & Biomedical Modeling, Biomedical Imaging and Biomedical Signal Processing, Biomaterials and Biopharmacy, Molecular Biology and Genetics, Pharmacology and Toxicology etc. Welcome to join us to exchange your new research findings with scholars all over the world!
Kontakt:
Linda;     Tel.: [+86-13018020541];     Email: icbeb@icbeb.org
Themen:
Biomedical engineering, biotechnology
Eintrags-ID:
1003027
77
CellMAT — 5th International Conference on Cellular Materials
24. Okt 2018 - 26. Okt 2018 • Bad Staffelstein, Deutschland
Zusammenfassung:
The activities in the development, manufacture and application of cellular materials are steadily growing. R&D of cellular materials constitutes a discrete but well-connected research field of materials science and engineering. Cellular materials are expected to be a driver of innovations and novel products and/or novel-type of processing and conversion. Over the last years, applications have been identified, e. g. in the fields of energy efficiency, light weight construction, novel and efficient chemical conversion concepts or biomedical repair functions. The CellMAT conference series was initiated in 2010 in order to bring together experts from the polymer, ceramic, glass and metal communities dealing with cellular materials.
Kontakt:
Alexia Ploetz;     Tel.: [0151 2122 7448];     Email: cellmat@dgm.de
Themen:
manufacturing, functionalization, surface modification, structure characterization, joining and machining, physical, chemical, mechanical, thermal, optical, in-situ, mechanical characterization, plastic deformation, recycling, standardization
Eintrags-ID:
1013539
78
ICBB2018 — 2018 International Conference on Biotechnology and Bioengineering
24. Okt 2018 - 26. Okt 2018 • Budapest, Ungarn
Zusammenfassung:
On behalf of the Organizing Committee, it is our great pleasure to welcome you to participate in the 2018 International Conference on Biotechnology and Bioengineering (8th ICBB) to be held in Budapest, Hungary during October 26-28, 2018. It has been designed to provide an innovative and comprehensive overview of biotechnology and bioengineering, a focus will be given to major research advances including: 1.New Approaches and Concepts in Biotechnology; 2.Cell & Immunology; 3.Genomics & Molecular Biology; 4.Enzyme & Protein Engineering; 5.Biomedicine, Pharmaceutical Biotechnology & Toxicology; 6.Bioinformatics & Systems Biology; 7.Biomedical engineering, Biomedical techniques & technologies, and other related aspects.
Kontakt:
Dr. Sun;     Email: icbb@apaset.org
Themen:
ICBB, Conference, biotechnology, bioengineering, 2018conference, Turkey, SCI
Eintrags-ID:
1006025
79
Course — Formulation Design and Troubleshooting of Dry Dosage Forms
29. Okt 2018 - 30. Okt 2018 • Berlin, Deutschland
Zusammenfassung:
This two-day pharmaceutical training course will explain the principles of dosage form design and how poor decisions at the design stage result in unstable processes and problem products. Product design should begin with identification of critical process and material parameters, but all too often this stage of the development is rushed and product yield and quality are compromised. Rectifying these problems retrospectively can be difficult and expensive. "Right the first time" is the key to success.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
Tablet, Capsule, Formulation, excipient, drug, substance, Granulation, drying
Eintrags-ID:
1012465
80
CIBV — 1st International Congress of Green Biotechnology
01. Nov 2018 - 02. Nov 2018 • Taroudant, Marokko
Zusammenfassung:
The 1st International Congress of Green Biotechnology will be organized in the Polydisciplinary Faculty of Taroudant in collaboration with the Ibn Zohr Association for Scientific Research and Sustainable Development. It will bring biotechnology experts from around the world and provide major innovations on plant biotechnology and their applications in agronomy. During this congress, the Plenary Conferences will allow the free discussion of new problems with experts in the field. Scientific sessions with presentations selected from the submitted abstracts will focus on specific thematic areas in biotechnology. The Posters sessions will give you the opportunity to discuss your results in more detail.
Kontakt:
ALILOU HAKIM;     Tel.: [+212 662044059];     Email: alilouhakim@gmail.com
Themen:
Biotechnology. agriculture, agro-industry, Pharmaceutical Biotechnology, green chemistry and biomolecules, Nanobiotechnology, Biotechnology and the Environment
Eintrags-ID:
980150
81
Course — European Union Regulatory Issues - New Product Development
05. Nov 2018 - 06. Nov 2018 • Berlin, Deutschland
Zusammenfassung:
This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
regulatory affairs, HTA, EMA, orphan, Paediatric, oncology
Eintrags-ID:
1012463
82
Course — Filing Variations in the European Union
07. Nov 2018 - 08. Nov 2018 • Berlin, Deutschland
Zusammenfassung:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Eintrags-ID:
1012451
83
Course — Preparing the CMC Section for MAAs-IMPDs
19. Nov 2018 - 20. Nov 2018 • Berlin, Deutschland
Zusammenfassung:
This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
CMC, Manufacturing, Controls, ◦Impurities, Solid State, •Container Closure System, DMF, CEP, Excipients, CTD
Eintrags-ID:
1012569
84
Course — QbD - Product & Process Optimization using Design of Experiments
26. Nov 2018 - 28. Nov 2018 • Berlin, Deutschland
Zusammenfassung:
Quality by Design (QbD) means that, starting from the very first development step, products and processes are designed in a way to ensure a high level of quality and reliability. One of the main QbD tools is statistical Design of Experiments (DoE), which enables to perform the necessary experiments in an efficient and structured way. This constitutes the most effective manner to identify the Critical Process Parameters (CPP’s) and Material Attributes (CMA’s) that, together, influence most the quality characteristics of highest concern, the so-called Critical Quality Attributes (CQA’s). Of course, the methodology can also be applied to optimize existing products or processes.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
QBD, Quality by Design, DoE, Modelling, Optimization, screening, Statistical Design
Eintrags-ID:
1012524
85
Course — Writing Effective SOP and Other Process Documents
06. Dez 2018 - 07. Dez 2018 • Berlin, Deutschland
Zusammenfassung:
This course presents a comprehensive overview of process writing that the binding regulations require. There's a tenet among regulatory bodies: "If you didn't write it down, it didn't happen," and while the regulations tell companies what they need to do and document, they don't tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the "big picture" of controlled documentation and gives industry standards for delivering information. Effectively prepared process documents keep companies on track and compliant. Participants will learn how to write documents that ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
SOP, Systems, Controls, document, writing, regulatory affairs,
Eintrags-ID:
1012482


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Stand vom 16. Februar 2018