Planning a Trial with Safety in Mind

Overview

This event is a complementary pre-event promotional webinar associated with the Global Pharmacovigilance and Risk Management Strategies Conference and open to the public.

Stakeholders will discuss the opportunities and challenges when using aggregate safety assessment plan as an approach for safety planning.

Please also check out DIA’s Global Pharmacovigilance and Risk Management Strategies Conference taking place February 6-8 in Bethesda, MD!

Meeting Designed For

Drug Safety
Pharmacovigilance
Risk Management
Benefit-risk Assessment and Communication
Medical Product Safety Assessment
Post-Market Studies
Real-World Evidence Generation
Regulatory Affairs
Clinical Research
Data Safety Monitoring and Analysis
Pharmacoepidemiology
Medical Information
Medical Communications
Medical Affairs
Health Outcomes

Learning objectives

At the conclusion of this session, participants should be able to:

Identify safety topics of interest and how these can require supplemental data collection forms and/or case adjudication
Determine when “standard” data analyses are insufficient and what type of additional analyses and graphical displays are required
Recognize knowledge gaps and how to best acquire the missing information

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Planning a Trial with Safety in Mind

Overview

Meeting Designed For

Learning objectives

Be informed and stay engaged.