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Hilton Baltimore Inner Harbor

Jan 26, 2025 9:00 AM - Jan 26, 2025 4:00 PM

401 W Pratt Street, Baltimore, MD 21201, USA

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

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Overview

*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 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. 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:
  • Explain the importance of multi-disciplinary product level safety planning for clinical development programs
  • Identify Safety Topics of Interest (STOI) for a product and plan for their evaluation during clinical development
  • Discuss how the ASAP supports the ongoing characterization of the product safety profile and creates efficiencies related to health authority query responses and regulatory filing activities
  • Describe how product level aggregate assessment supports IND safety reporting decisions
  • Recognize the operationalize event search strategies including FDA Medical Queries (FMQs) as well as Standard Safety Tables and Figures and how they are utilized

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