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Baltimore Marriott Waterfront

Feb 04, 2024 9:00 AM - Feb 04, 2024 4:00 PM

700 Aliceanna Street , Baltimore, MD 21202

Short Course: Aggregate Safety Assessment Planning (ASAP) Process

This is a In-Person Pre-Conference Short Course in conjunction with the Global Pharmacovigilance and Risk Management Strategies Conference


*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

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.

Plans are nothing; planning is everything.
–Dwight D Eisenhower

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

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