ACDRS 2021 Session 5: The Global Registration and Approval Process
This is Session 5 of 6. Must register for the entire course and not per Session.
Session Co-chairpersons:
Daniela Drago, PhD RAC, Chief Regulatory Officer, Aurion Biotech
Christine E. Garnett, PharmD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, United States Food and Drug Administration (US FDA)
Murray "Mac" Lumpkin, MD MSc, Deputy Director - Integrated Development (Regulatory Affairs) and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Teaching Faculty
Wilson Bryan, MD |
Director, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research (CBER), US FDA |
Elizabeth (Betsy) A. Desrosiers | Executive Director, Clinical Sciences and Study Management Head for ID and Vaccines, Merck |
Daniela Drago, PhD RAC | Chief Regulatory Officer, Aurion Biotech |
Michael Dyszel |
Senior Director, Global Program Head, TA POE & CSR, Bayer US LLC |
Sara Eggers, PhD |
Office of Program and Strategic Analysis/Office of Strategic Programs, Center for Drug Evaluation and Research (CDER), US FDA |
Dionna Green, MD FCP | Acting Director, Office of Pediatric Therapeutics, Office of Clinical Policy and Programs, Office of the Commissioner, US FDA |
Florence Houn, MD MPH FACP |
Consultant |
David King, PhD |
Senior Director of Regulatory Affairs, Healx |
Zili Li, MD MPH | Vice President, Head of Asia Pacific R&D, Janssen Research & Development |
Murray “Mac” Lumpkin, MD MSc | Deputy Director – Integrated Development (Regulatory Affairs) and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation |
Anabela Marcal | European Medicines Agency Liaison at US FDA |
Diane Maloney, JD |
Associate Director for Policy, Office of the Director, Center for Biologics Evaluation and Research, US FDA |
Fortunato (Fred) Senatore, MD PhD FACC | Medical Officer, Division of Cardiology and Nephrology, CDER, US FDA |
Peter Stein, MD |
Director, Office of New Drugs, CDER, US FDA |
Toshiyoshi Tominaga, PhD | Senior Advisor, Japan Self-Medication Industry |
Lynne Yao, MD |
Director, Division of Pediatrics and Maternal Health, CDER, US FDA |
Judith Zander, MD |
Director, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, CDER, US FDA |
Additional faculty - case study proctors
Gideon Blumenthal, MD |
Vice President Oncology Global Regulatory Affairs, Merck |
Charlie T. Gombar, PhD | ACDRS Director |
Jamie Legg |
Asset Strategy Leader, Immunology, AbbVie |
Magda Michna, PhD |
Chief Global Clinical, Medical and Regulatory Affairs Officer, AcuFocus, Inc. |
Topics
- US Food and Drug Administration (FDA) applicable laws, regulations, and guidance documents
- FDA’s Center for Drug Evaluation and Research (CDER) new drug clinical trial and marketing authorization review processes
- US benefit-risk methodology and considerations
- US labeling requirements
- US regulatory outcomes and appeals
- US regulatory approaches to post-marketing
- US regulatory requirements for pediatrics, rare diseases, and gene therapies
- Challenges with and approaches to multi-country clinical trials
- Starting a clinical trial and obtaining scientific advice in the European Union, the United Kingdom (UK), Japan, China, low-income countries, and the US
- Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Authority (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, National Medical Products Administration (NMPA) of China, WHO’s Prequalification Program and its collaborative process with low-income country National Regulatory Authorities, and the US FDA