Professionals involved in the planning, preparation, coordination and review of aggregated safety reports.
In particular:
Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).
Participant experience
Basic knowledge of drug development and pharmacovigilance.
Register


Roberta Alberti
Events & Training Manager
At the end of the training path, you will be able to

Understand the main pharmacovigilance activities in the life cycle of the medicinal product

Plan and prepare DSUR, PSUR/PBRER, RMP, and AddCO, exploiting similarities and synergies among the different documents

Apply writing skills to the preparation of pharmacovigilance documents

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