Tagungen und Workshops zum Thema Legislation in der Medizin und Pharmakologie

Wählen Sie ein Land aus:
Großbritannien (1) - Indien (2) - Kanada (1) - Schweiz (1) - Singapur (4) - Vereinigte Staaten (10)

ALLE LÄNDER

1
18th Pharmacovigilance 2019
27. Feb 2019 - 28. Feb 2019 • London, Großbritannien
Zusammenfassung:
18th Annual Pharmacovigilance 2019 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organizations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organization’s compliance with pharmacovigilance requirements. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.
Kontakt:
Tel.: [+44 2036120886];     Email: kavitha@virtueinsight.co.in
Themen:
Pharmacovigilance Pharmacogenomics Drug Safety Product Safety Drug Development Clinical Safety Risk Management Patient Safety
Eintrags-ID:
1156438
2
Course — FDA's Medical Device Software Regulation Strategy
28. Feb 2019 - 01. Mär 2019 • San Francisco, CA, Vereinigte Staaten
Zusammenfassung:
This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance, proprietary software, FDA medical device recalls, warning letters, risk management
Eintrags-ID:
1181877
3
Course — How to apply ISO 62304 standard in a medical software development project?
04. Mär 2019 - 05. Mär 2019 • Zurich, Switzerland, Schweiz
Zusammenfassung:
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
ISO 62304 standard for medical software development, medical software development project, post market process, medical software risk management process, quality management system, ISO 13485, EU MDR, medical software maintenance process
Eintrags-ID:
1181854
4
2nd Annual Pharma Regulatory Summit 2019
14. Mär 2019 • Mumbai, Indien
Zusammenfassung:
This Pharma Regulatory Summit is the leading platform for regulatory experts, to be updated with latest country updates and strategies to navigate the complex and ever changing regulations in the region. This conference will focus on the new strategies, amendments, innovations, developments in the fields of regulatory affairs, intellectual property and medical devices, which reflects new strategies in the field of regulatory affairs. Regulatory Affairs additionally have certain significance inside the Healthcare industries, such as pharmaceuticals, medical devices, biologics and practical nourishments.
Kontakt:
Tel.: [+91 44 24762472];     Email: kavitha@virtueinsight.co.in
Themen:
Regulatory Affairs Regulatory Writing, Medical Writing, Publishing, Information, Submissions
Eintrags-ID:
1158519
5
Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!
15. Mär 2019 • Chicago, IL, Vereinigte Staaten
Zusammenfassung:
All these topics and more will be covered in this jam-packed one-day program. The day will start with an overview of the state of the art in case management today, how we got here, and where we are going in the future. From there we will discuss the often-confusing subject of all the roles that occur in best practice departments.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"case management boot camp, case management training, case management workshop, affordable care act, accountable care organizations (ACOs), CMS rules, utilization management, NOTICE Act, HINNs."
Eintrags-ID:
1182859
6
How to apply ISO 62304 standard in a medical software development project?
18. Mär 2019 - 19. Mär 2019 • Singapore, Singapur
Zusammenfassung:
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"ISO 62304 standard for medical software development, medical software development project, post market process, medical software risk management process, quality management system, ISO 13485, EU MDR, medical software maintenance process"
Eintrags-ID:
1182825
Verwandte Fachgebiete:
7
Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)? By:
20. Mär 2019 • Singapore, Singapur
Zusammenfassung:
This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"Medical Device Single Audit Program (MDSAP), MDSAP in existing QMS, European Notified Body Audits, MDSAP Management Processes, Adverse Event Reporting, Field Safety Corrective Actions"
Eintrags-ID:
1182846
8
How to Implement a Quality Management System According ISO 13485?
21. Mär 2019 - 22. Mär 2019 • Singapore, Singapur
Zusammenfassung:
Attend this seminar to learn medical device quality management standard ISO 13485. It will cover the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit is working.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"ISO 13485 seminar, quality management system, ISO 13485 Audit, medical device quality management system"
Eintrags-ID:
1182865
9
Writing Technical Documents for FDA — Technical and Regulatory Writing for FDA-Regulated Industry
21. Mär 2019 - 22. Mär 2019 • Washington DC, Vereinigte Staaten
Zusammenfassung:
Regulatory professionals have to write highly technical documents for a variety of audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.

The trainers will provide practical tips using examples on how to organize and deliver information into clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favorable reception by the regulatory agencies. The workshop will also discuss rules for writing documents intended for electronic submission to regulatory agencies. This one-of-a-kind workshop will provide technical, practical, logical and logistical tips for regulatory writers of all levels of skills.

Kontakt:
Tel.: [410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1177300
10
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
21. Mär 2019 - 22. Mär 2019 • Tampa, FL, Vereinigte Staaten
Zusammenfassung:
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"Latin America regulations, Latin America life sciences regulations, Latam life sciences regulatory requirements, Latin America pharmaceutical regulations, Latin America medical device regulations, Latin America biologics regulations, Argentina life sciences regulations, Argentina medical device regulations, Argentina biologics regulations, Brazil life sciences regulations, Brazil medical device regulations, Brazil biologics regulations, Mexico life sciences regulations, Mexico medical device regulations, Mexico biologics regulations, Latin America clinical requirements, Latin America pre-clinical requirements "
Eintrags-ID:
1182867
11
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
21. Mär 2019 - 22. Mär 2019 • Chicago, IL, Vereinigte Staaten
Zusammenfassung:
This session is designed to provide an intensive, one and a half-day training in HIPAA Privacy Rule compliance designed for both the seasoned HIPAA professional as well as the individual newly appointed to the position of HIPAA Privacy Officer, covering.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"HIPAA privacy rule, HIPAA regulations, HIPAA compliance"
Eintrags-ID:
1182833
12
Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings
28. Mär 2019 - 29. Mär 2019 • Philadelphia, PA, Vereinigte Staaten
Zusammenfassung:
In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"conducting FDA meetings, investigational new drug (IND), investigational device exemptions (IDE) applications, investigational device exemptions (IDE) applications, guidance documents for drug and device submissions, IND and IDE application process, IND maintenance, orphan drug designation, IDE maintenance, humanitarian device exemption (HUD), investigational new drug application preparation"
Eintrags-ID:
1182841
13
Pharmaceutical Quality Management System
02. Apr 2019 - 03. Apr 2019 • Singapore, Singapur
Zusammenfassung:
This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.
Kontakt:
Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
"pharma quality management workshop, good manufacturing practices (cGMP), ICH guidance for pharma quality management, ICH-Q7, ICH-Q8, ICH-Q9, ICH-Q10, ICH-Q11, Quality by Design (QbD), 21 CFR Part 11, MHRA guidance on data integrity, 21 CFR 314 for post market surveillance, ICH-Q9 Risk Management, SOPs, contamination control, vendor/supplier qualification, packaging operations, GMP lab, stability program, change Control"
Eintrags-ID:
1182939
14
FDA eCTD Training Seminar — eCTD Submissions of IND and NDA/BLA to the US FDA
04. Apr 2019 • Washington DC, Vereinigte Staaten
Zusammenfassung:
The eCTD training workshop will provide the attendees with step-by-step instructions in creating and submitting eCTD submissions for IND, NDA, BLA, and ANDA applications without the need for expensive tools or unreasonable efforts. This no-frills workshop aims to train in the minimum skills needed and provide hands-on practical tips to create eCTD submissions. The trainers will use their own case studies of how eCTD submissions were created and successfully submitted to the FDA using indigenous tools and expertise. Also discussed will be logistical issues associated with managing and maintaining eCTD compliance with regards to all regulatory submissions. This workshop will be beneficial to both the novices and experienced in the field.
Kontakt:
Tel.: [410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1177332
15
Canadian Academy Of Psychiatry And The Law Annual Conference 2019
28. Apr 2019 - 01. Mai 2019 • West Montréal , QC, Kanada
Eintrags-ID:
1143677
Verwandte Fachgebiete:
16
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
09. Mai 2019 - 10. Mai 2019 • Boston, Vereinigte Staaten
Zusammenfassung:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Kontakt:
Tel.: [+410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1196594
17
Clinical Project Management Training — One Day Online Training in Clinical Project Management
20. Mai 2019 • Washington DC, Vereinigte Staaten
Zusammenfassung:
Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.
Kontakt:
Tel.: [+410 501 5777];     Email: pkumar@fdamap.com
Eintrags-ID:
1196581
18
CRO2019 — CRO/Sponsor Summit
23. Mai 2019 - 24. Mai 2019 • Hyderabad, Indien
Zusammenfassung:
Ensuring the quality of the clinical data generated for regulatory submissions is a major challenge today for both the Clinical Research Organizations (CROs) as well as the Sponsors Pharmaceutical Organizations. Where on one hand, computerization, automation, and LIMS have helped in data management, on the other hand, it has also made data alterations much easier. Therefore, for regulatory success both the CRO conducting the study and the Sponsors have to play a pivotal role in ensuring quality in clinical studies.
Kontakt:
Tel.: [7986926833];     Email: sb.jatinkashyap@gmail.com
Themen:
Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors, Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development, CRO/Sponsors
Eintrags-ID:
1182408
19
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop
23. Sep 2019 - 25. Sep 2019 • Washington, D.C., Vereinigte Staaten
Veranstalter:
American Statistical Association
Eintrags-ID:
1145492


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Stand vom 12. Februar 2019