DIA Global Pharmacovigilance and Risk Management Strategies Conference Short Course: Aggregate Safety Assessment Planning (ASAP) Process
Taught by Greg Ball PhD, Safety Scientist, and Barbara Hendrickson MD, Safety Physician, this session will describe how the ASAP supports multidisciplinary safety planning, ongoing aggregate safety evaluation, IND safety reporting decisions, and evaluation of product level safety data and the Safety Topics of Interest, which have the potential to influence a product’s benefit: risk...