Attestato di partecipazione
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.
Registrati
Roberta Alberti
Events & Training Manager
Cosa saprai fare dopo il percorso formativo
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
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
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