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Regulatory Aspects in Pharmacovigilance and Practical Examples




London, United Kingdom


09 Oct 2018 - 10 Oct 2018

Reference No: D1802237 - DIA

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Key points about this Training Event

  • Provide an understanding of safety data classification, using MedDRA terminology and safety data retrieval using Standardised MedDRA Queries (SMQs)
  • Key Elements of a quality system in Pharmacovigilance including aspects of the applicable GVP modules
  • Elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections
Event Description

Course Outline:

The roles and responsibilities of marketing authorisation holders and national Competent Authorities in the conduct of Pharmacovigilance are defined in EU legislation and further detailed in the Good Pharmacovigilance Practices (GVP)

Module 2 will provide the safety reporting requirements with case studies, the roles and responsibilities of all stakeholders of clinical trials in line with the implementing texts published in relation to Directive 2001/20/EC and the new Regulation (EU) 536/2014

When & Where?

9 October 2018 - 10 October 2018

De Vere Venues 1 Westferry Circus
Canary Wharf
E14 4HA
United Kingdom


Course fee for members of DIA: €1450
Course fee for delegates : €1605

Applicant Requirements
  • Stakeholders of Clinical Trials
Reference No: D1802237 - DIA
DIA, a non-profit association, is the only global organization dedicated to bringing health care product development professionals together in a trusted, global, neutral environment to share insights and drive action in health care product development and life cycle management


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