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 assessment. An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure appropriate collection and assessment of product level data and to answer key safety questions from various stakeholders. In addition, the ASAP process strengthens safety signal detection as well as risk identification and management. The American Statistical Association Biopharma Safety Scientific Working Group has proposed an ASAP template to guide sponsor teams in clinical development.