Track 9: Regulatory
This track is composed of sessions addressing global laws, regulations, guidelines, and guidance’s that govern prescription biopharmaceutical and device product development, approval, and maintenance. Representatives from FDA, Health Canada. NMPA (National Medical Products Administration), PMDA (Pharmaceuticals and Medical Devices Agency), EMA, MHRA (Medicines and Healthcare products Regulatory Agency) (Medicines and Healthcare products Regulatory Agency), European Health Authorities and ICMRA authorities, and other regulatory experts will provide global updates, insights, and discussion on current issues through interactive forums. Themes commonly revolve around global regulatory changes and impact on global development strategies, global harmonization/convergence and impact on drug development and advances and innovations to improve the practice of regulatory affairs, and regulatory hot topics are always prominently featured.
DIA recommends this track and associated sessions to professionals involved in regulatory affairs and strategy, regulatory operations, regulatory information management, regulatory agencies, government affairs, legal affairs and compliance, policy and intelligence, clinical research and operations, PV, HTA (Health Technology Assessment), project management, and service providers developing tools and resources for use by sponsors and CROs.
Included Topic Areas
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Regulatory affairs, regulatory policy, regulatory intelligence, regulatory strategy, global and US advertising and promotional regulations and laws; regulatory operation best practices, regulatory science, eSubmissions, regulatory document management; regulation pertaining to study endpoints, product labeling, biosimilars, combination products, advanced therapies (e.g., regenerative medicine, tissue products, gene therapy), companion diagnostics, devices. Topics related to bioethical issues are also welcome and may be considered for a special track in the meeting.
- Innovative Approaches to Clinical Development Programs and Trial Design, Including Experience with Acceptance for Regulatory Decision Making and Case Studies (e.g., complex innovative designs, use of digital health technologies in a clinical development program, model informed drug development, decentralized clinical trials, novel biomarkers and endpoints, patient centric approaches, real-world evidence)
- Global Development and International Harmonization, Convergence, Reliance, and Cooperation
- Regulatory Topics of Public Health Importance
- What’s New in Labeling
- Regulatory Initiatives to Increase Competition
- Latest Regulatory Developments in Cutting-Edge Science and Review
- Harnessing Big Data/Bioinformatics to Answer Regulatory Questions
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