Meetings/Workshops on Biotechnology in Germany

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Austria (1) - Belgium (2) - Canada (1) - China (2) - Germany (13) - Hungary (1) - Italy (8) - Morocco (1) - Spain (2) - Turkey (1) - Uganda (1) - United Kingdom (3) - United States (12) - ALL COUNTRIES (48)

1
Course — European Regulatory Procedures - EMA & National Requirements
13 Sep 2018 - 14 Sep 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Event listing ID:
1012351
2
5th Laupheim Biotech Days 2018
20 Sep 2018 - 21 Sep 2018 • Laupheim, Germany
Abstract:
With the topic "Bioprocess Intensification" the 5th Biotech Days will spotlight all aspects of the intensification of cell culture-based bioprocesses in the biopharmaceutical industry. The conference will include both up- and downstream processing and will sport a scientific bandwidth ranging from molecular switches to loop-controlled hybrid processes and intelligent purification strategies. This turns the 5th Biotech Days into an ideal stage for a rich diversity of strategies to modify process-specific key attributes, enabling a significant enhancement of productivity, product quality, reliability and consistency as well as product safety.
Event listing ID:
1088264
3
Course — Technical Writing for Pharma, Biotech and Med Devices
26 Sep 2018 - 28 Sep 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
medical writing, Language,
Event listing ID:
1012404
4
Course — ADME, PK/TK & Drug Metabolism in Drug Discovery and Development
09 Oct 2018 - 11 Oct 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
ADME, Toxicokinetics, Drug Metabolism, Metabolite Isolation, Pharmacokinetic, PK/TK
Event listing ID:
1012469
5
Course — Auditing and Qualifying Suppliers and Vendors
15 Oct 2018 - 16 Oct 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
outsourcing, audits, supplier, vendor, QC, change control, equipment, Calibrations, Laboratories, Maintenance
Event listing ID:
1012446
6
CellMAT — 5th International Conference on Cellular Materials
24 Oct 2018 - 26 Oct 2018 • Bad Staffelstein, Germany
Abstract:
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.
Contact:
Phone: [0151 2122 7448];     Email: cellmat@dgm.de
Topics:
manufacturing, functionalization, surface modification, structure characterization, joining and machining, physical, chemical, mechanical, thermal, optical, in-situ, mechanical characterization, plastic deformation, recycling, standardization
Event listing ID:
1013451
7
Course — Formulation Design and Troubleshooting of Dry Dosage Forms
29 Oct 2018 - 30 Oct 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
Tablet, Capsule, Formulation, excipient, drug, substance, Granulation, drying
Event listing ID:
1012443
8
Course — European Union Regulatory Issues - New Product Development
05 Nov 2018 - 06 Nov 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
regulatory affairs, HTA, EMA, orphan, Paediatric, oncology
Event listing ID:
1012441
9
Course — Filing Variations in the European Union
07 Nov 2018 - 08 Nov 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Event listing ID:
1012451
10
Course — Preparing the CMC Section for MAAs-IMPDs
19 Nov 2018 - 20 Nov 2018 • Berlin, Germany
Abstract:
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).
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
CMC, Manufacturing, Controls, ◦Impurities, Solid State, •Container Closure System, DMF, CEP, Excipients, CTD
Event listing ID:
1012481
11
Course — QbD - Product & Process Optimization using Design of Experiments
26 Nov 2018 - 28 Nov 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
QBD, Quality by Design, DoE, Modelling, Optimization, screening, Statistical Design
Event listing ID:
1012568
12
Course — Writing Effective SOP and Other Process Documents
06 Dec 2018 - 07 Dec 2018 • Berlin, Germany
Abstract:
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.
Contact:
Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
SOP, Systems, Controls, document, writing, regulatory affairs,
Event listing ID:
1012471
13
5th Euro BioMAT - European Symposium and Exhibition on Biomaterials and Related Areas
08 May 2019 - 09 May 2019 • Weimar, Germany
Abstract:
Based on the huge success of the previous four Euro BioMAT Symposia 2011 in Jena and in 2013, 2015 and 2017 in Weimar this international conference will be held every two years in the Jena-Weimar region. The symposium Euro BioMAT 2019, 08.-09. May 2019, addresses the growing interest of science and industry in the different aspects of the creation, characterization, testing and application of biomaterials and closely related areas. The motivation is not only the recent scientific progress and new challenges of this exciting, strongly interdisciplinary field of science and engineering. Materials scientists, physicists, chemists, biologists in industrial R&D as well as medical professionals are increasingly facing situations, where materials are confronted with high performance requirements and a challenging biological environment at the same time.
Contact:
Phone: [+49 (151) 2122 7448];     Email: biomat@dgm.de
Event listing ID:
1088233

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Last updated: 20 June 2018