Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2025 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes
Date:
Wednesday, September 10, 2025 - 8:00 am to Friday, September 12, 2025 - 4:00 pm
Location:
University of California Washington Center (UCDC), 1st floor meeting room
1608 Rhode Island Ave NW, Washington DC
This is Session 5 of 6. Must register for the entire 2024 Course and not per session.
Session Co-chairpersons:
Daniela Drago, PhD RAC FRAPS FTOPRA, Expert Consultant, NDA Partners
Christine E. Garnett, PharmD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA)
Lecturers
| Yumiko Asano, MSc | Head of Chugai Partnering, Chugai Pharmaceutical Co., Ltd. |
| Danielle Corwin, PhD | Chief of Staff, Global Regulatory Strategy and Business Excellence, GRA – Specialty Care, Sanofi |
| Daniela Drago, PhD RAC FRAPS FTOPRA | Partner, NDA Partners |
| Michael Dyszel | R&D Project Excellence Lead, CSL Behring |
| Sara Eggers, PhD | |
| Lola Fashoyin-Aje, MD MPH | |
| Maria Jison, MD FCCP | Global Clinical Head, Fasenra, AstraZeneca |
| Claudia Manzo, PharmD | Head, Office of Risk Management, Pharmacovigilance, and Patient Safety, AbbVie |
| Adora Ndu, PharmD JD | Chief Regulatory Affairs Officer, BridgeBio |
| Kimberly Wolfram, MS | Head of Global Regulatory Affairs CMC, Biologics/ATMP, Biogen |
| Wendy (Xiaojun) Yan, MBA | Senior Vice President, Senior Advisor, BeiGene, Ltd |
| Michelle Zucatti, MHA | Strategic Communications Lead, 3D Communications |
| others to be confirmed |
Additional faculty - case study proctors
| Charlie T. Gombar, PhD | ACDRS Director |
| others to be confirmed |
Topics (subject to change)
- US 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 rare diseases and cell and gene therapies
- Enhancing diversity in clinical trial populations
- Chemistry, Manufacturing, and Control (CMC) section of regulatory applications
- US FDA advisory committee meetings and CHMP oral explanations
- Starting a clinical trial and obtaining scientific advice in the European Union, China, and Japan
- Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), National Medical Products Administration (NMPA) of China, Pharmaceuticals and Medical Devices Agency of Japan, and the US FDA
- Development of pediatric therapeutics
- Real-world data and real-world evidence
- Artificial intelligence and machine learning in drug development