Early Development & Drug Safety (EDDS) Community

Community Goals:

Facilitate communication and collaboration amongst industry, academic, consultant and regulatory pharmacologists interested in early drug development and safety by:
  • Providing a venue for discussion and exchange of ideas amongst Community members at the Annual Meeting.
  • Supporting Community proposals for abstracts, workshops and symposia on early development and drug safety.
  • Promote advances in early drug development and safety by highlighting cutting edge approaches and hot topics in the scientific program and special sessions including webinars and pre-conferences. 
Community News
Recent Webinar
Title: Safety Assessment in Phase 1 Healthy Volunteer Trials
Description: The fatality in January 2016 at the French Phase 1 contract research organization focused global attention on safety for healthy volunteers. This presentation will outline the regulatory context, evaluate the safety considerations in phase 1 trials and lessons learned from the recent French experience. 
Learning Objectives:
  • Understand how previous adverse experiences shape the regulatory landscape. 
  • Learn how non-clinical data inform human experiences in phase 1 trials. 
  • Realize risks to volunteers in phase 1 trials and lessons from recent experience 
Please log in as a member to access the recording below.
528 N Washington St, Alexandria, VA 22314 |  Ph: 703.836.6981 |