Benefit-Risk Management

ONLY 1 OFFERING IN 2017! Our best-in-class instructors teach you the Do’s and Don’ts for BRM over the lifecycle of the product, and the course includes the Rev 2 of the GVP Modules V and XVI.

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SESSION 7: EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

Session Chair(s)

Jan Petracek, MD, MSc

CEO

Ivigee, Czech Republic

Creation of efficacy specification and relevant regulatory discussions in EU-RMPs and PSURs(PADERs)
Design of studies and registries used in the efficacy follow-up planning
Matching efficacy concerns with the efficacy follow-up planning

Speaker(s)

EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

Jan Petracek, MD, MSc

Ivigee, Czech Republic

CEO

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Benefit-Risk Management

SESSION 7: EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

Session Chair(s)

Jan Petracek, MD, MSc

Speaker(s)

EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

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