ACDRS 2026 Session 5: Global Clinical Trials Authorization & Marketing Authorization Processes

Must be registered in advance to attend.

Topics

• US FDA applicable laws, regulations, and guidance documents
• FDA’s new drug clinical trial and marketing authorization review processes
• US benefit-risk methodology and considerations
• US labeling requirements
• US regulatory actions and outcomes for NMEs, NDAs, and BLAs
• US regulatory approaches to post-marketing
• US regulatory requirements for rare diseases, pediatric therapeutics, and cell & gene therapies
• Challenges with and approaches to multi-country clinical trials
• US FDA advisory committee meetings and CHMP oral explanations
• CMC section of regulatory applications
• FDORA, PDUFA VII, and their impact on US FDA-regulated industry and US FDA
• Starting a clinical trial and obtaining scientific advice in the EU, Japan, China, and the US
• Procedures and approaches to obtain marketing authorizations from the European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency of Japan, National Medical Products Administration (NMPA) of China, and US FDA
• Enhancing diversity in clinical trial populations
•  Implementation of Artificial Intelligence at US FDA

Topics subject to change

Speakers

• Eric Brodsky, MD, Associate Director, Labeling Policy Team, OND, CDER, US FDA
• Danielle Corwin, PhD, Chief of Staff, Global Regulatory Strategy and Business Excellence, GRA – Specialty Care, Sanofi
• Corinne de Vries, European Medicines Agency (EMA) Liaison Official at US FDA
• Daniela Drago, PhD RAC FRAPS FTOPRA, Partner, NDA Partners
• Michael Dyszel, Global Product Lead - Immunoglobulins, CSL Behring 
• Lola Fashoyin-Aje, MD MPH, Vice President, Head of Cell Therapy Regulatory Science & Strategy, AstraZeneca
• Christine Garnett, PharmD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), US FDA
• Glen Huang, MD, Senior Physician, Division of Antivirals, OND, CDER, US FDA
• Jae Kim, JD, Partner, DLA Piper
• Claudia Manzo, PharmD, Head, Office of Risk Management, Pharmacovigilance, and Patient Safety, AbbVie
• Adora Ndu, PharmD JD, Chief Regulatory Affairs Officer, BridgeBio
• Fortunato (Fred) Senatore, MD PhD FACC, Lead Physician, Division of Cardiology and Nephrology, OND, CDER, US FDA
• Kimberly Wolfram, MS, Head of Global Regulatory Affairs CMC, Biologics/ATMP, Biogen
• Wendy (Xiaojun) Yan, MBA, Senior Vice President, Senior Advisor, BeOne Medicines
• Sarah Zaidi, MD, Medical Officer, Office of Pediatric Therapeutics, US FDA
• Michelle Zucatti, MHA, Strategic Communications Lead, 3D Communications
• others to be confirmed