ACDRS 2022 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes
This is Session 5 of 6. Must register for the entire 2022 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, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER), 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
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
Lecturers/Panelists
Wilson Bryan, MD | Director, Office of Tissues and Advanced Therapies, CBER, US FDA |
Daniela Drago, PhD RAC | Chief Regulatory Officer, Aurion Biotech |
Mike Dyszel | Senior Director, Global Program Head, Pulmonology/Ophthalmology/Established Products & CSR, Bayer US LLC |
Sara Eggers, PhD |
Director, Decision Support and Analysis Staff, Office of Program and Strategic Analysis/Office of Strategic Programs, CDER, US FDA |
Janice Evans |
Senior Advisor, Regulatory, Eli Lilly |
Florence Houn, MD MPH FACP | Consultant |
Andy Lee | Senior Vice President, Global Clinical Trial Operations, Merck |
Zili Li, MD MPH | Vice President, Head of Asia Pacific R&D, Janssen Research & Development (China) |
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 (EMA) Liaison Official at US FDA |
Adora Ndu, PharmD JD | Chief Regulatory Affairs Officer, BridgeBio |
Fortunato (Fred) Senatore, MD PhD FACC |
Medical Officer, Division of Cardiovascular and Renal Products, CDER, US FDA |
Peter Stein, MD |
Director, Office of New Drugs, CDER, US FDA |
Toshiyoshi Tominaga, PhD |
Project Professor, Clinical and Translational Research Center, School of Medicine, Keio University (Japan) |
Lynne Yao, MD |
Director, Division of Pediatrics and Maternal Health, CDER, US FDA |
Judith Zander, MD |
Director, Office of Pharmacovigilance and Epidemiology (OPE), Office of Surveillance and Epidemiology (OSE), CDER, US FDA |
Additional faculty - case study proctors
Lauren Brunke, PharmD RPh | Director, Global Labeling, Regulatory Affairs, Eli Lilly and Company |
Janelle Burnham, MD | Clinical Director, Pediatric Center of Excellence, Pfizer |
Nicholas Langevin, MS RAC | Director, Regulatory Affairs, Sunovion Pharmaceuticals |
Todd Page, PhD DABT | Senior Director, Global Regulatory Affairs - North America, Eli Lilly and Company |
Lt. Commander Melissa A Reyes, MD MPH FAAD DTMH | Medical Officer, Division of Pharmacovigilance I, OPE, OSE, CDER, US FDA |