ACDRS 2023 Session 5 - Global Clinical Trials Authorization and Marketing Authorization Processes

Wednesday, September 27, 2023 - 8:00 am to Friday, September 29, 2023 - 4:00 pm
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 2023 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, 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 (subject to change)

  • 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