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...

Greg will present, along with colleagues from Roche and Bristol Myers Squibb, to the Safety and Pharmacovigilance Track of the Drug Information Association's Annual European Meeting on: Regaining Global Alignment on Safety Reporting from Clinical Trials.