Perez-Gutthann S. Pharmacoepidemiology in society and industry risk management, PASS, and RWE key guidances. Presented at the Pharmacovigilance Diploma. An International Training Program; March 15, 2019. Copenhagen, Denmark.

Outline of Topics, Objectives and Learning Outcomes

• To provide students with an overview of

– The role of epidemiology / RWE in pharmaceutical research and development: from discovery to pre-approval and post-approval

– The origin and key elements of the most relevant guidance for good pharmacoepidemiology practice

• To enable students to be aware of and able to access the tools that are available to support good practice in the area of pharmacoepidemiology

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