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NH Berlin Alexanderplatz

24 abr 2017 8:00 a.m. - 25 abr 2017 3:15 p.m.

Landsberger Allee 26-32, 10249 Berlin, Germany

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.

SESSION 7: EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

Session Chair(s)

Jan  Petracek, MD, MSC

Jan Petracek, MD, MSC

CEO

iVigee Services a.s., 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)

Jan  Petracek, MD, MSC

EFFICACY SPECIFICATION AND FOLLOW-UP PLAN

Jan Petracek, MD, MSC

iVigee Services a.s., Czech Republic

CEO

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