Pharmacovigilance System Master File & Inspections 2014
June 12 - 13, 2014
Frankfurt , Germany
The EU Directive 2010/84/EU introduced a new format of organization of pharmacovigilance processes, the Pharmacovigilance System Master File (PSMF).This training will offer its participants practical knowledge on how to transition to PSMF, onferencecalendarmaintain it and ensure it meets inspectors' and industry's standards.
KEY TOPICS
Change management of system – how to do it in a timely and efficient manner?
Deconstructing GVP Module II
Audit findings
Ensuring compliance with legal requirements for PSMF
Inspectors‘ expectations and mistakes to avoid
KEY TOPICS
Change management of system – how to do it in a timely and efficient manner?
Deconstructing GVP Module II
Audit findings
Ensuring compliance with legal requirements for PSMF
Inspectors‘ expectations and mistakes to avoid
Related events
Pharmacovigilance System Master File & Inspections June 12 - 13, 2014
