The DIA Statistics and Data Science Community are excited to see that our Aggregate Safety Assessment Planning (ASAP) expert Gregg Ball, PhD, is teaming up with Barbara Hendrickson, MD to deliver the ASAP training short course at the upcoming DIA Global Pharmacovigilance and Risk Management Strategies Conference, taking place on Feb 4th 2024, Baltimore MD.
An Aggregate Safety Assessment Planning (ASAP) process is critical to ensure collection and assessment of product level data 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 Drug Information Association–American Statistical Association Interdisciplinary Safety Evaluation (DAISE) scientific working group has proposed an ASAP template to guide sponsor teams in clinical development. 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.
Registration for Live Short Course will be accepted onsite, or until capacity has been reached. Register prior to guarantee your seat.
Learning objectives
Upon completing this course, attendees will be able to:
- Identify Safety Topics of Interest (STOI) for a product and plan for their evaluation during clinical development
- Comply with requirements for aggregate IND safety reporting
- Scientifically evaluate accumulating program-level safety information
- To support ongoing characterization of the product safety profile
- To prepare for regulatory filing activities and responses to regulatory queries
- Operationalize FDA Medical Queries (FMQs) and Standard Safety Tables and Figures
To register please use the URL below:
https://www.diaglobal.org/conference-listing/meetings/2024/02/global-pharmacovigilance-and-risk-management-strategies-conference/tutorials/aggregate-safety-assessment-planning-asap-process