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Research and Markets: Pharmacovigilance Audits and Inspections - New Meeting (Course, London)
[May 09, 2014]

Research and Markets: Pharmacovigilance Audits and Inspections - New Meeting (Course, London)

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Pharmacovigilance Audits and Inspections - New Meeting (Course, London)" conference to their offering.

The Pharmacovigilance Audits and Inspections - New Meeting will take place on the 01-02 July 2014 at The Rembrandt Hotel, London

The purpose of this course is that through both a practical review of the purpose of internal audits to assess a Company's current systems and understand potential pitfalls, there is also a review of the current Regulatory attitudes and mechanisms for Inspections, the level of findings and penalties which may face and are facing Pharmaceutical Companies, both big and small; innovator and generic and within the EU ad globally.

Benefits in Attending:

  • Understand the Purpose and Requirements of Pharmacovigilance Audits
  • Discuss the Scope and Content of the Audit Report
  • Plan your Audit Corrective Action Plans
  • Gain an Understanding of the Conduct of a Regulatory Inspection
  • Take Away Practical Tips on how to Prepare for an Inspection
  • Discuss Common Findings from Regulatory Inspections

Pharmaceutical Companies have been inspected by Regulatory Authorities for nearly 15 years. This has meant that there is now a level of expectation from both the Regulators and Industry that there has been enough time and knowledge to understand what is required as a responsible license holder.

Key Topics Covered:

Day 1 - 1 July 2014

09.30 - Welcome & Introduction

10.30 - Quality Management

11.15 - Coffee

11.35 - The Legislation and Audits

12.30 - Lunch

13.30 - The Audit & Report

14.40 - Practical Exercise

15.15 - Tea

15.35 - Continuation of Practical Exercise

16.00 - The Audit Cycle

17.00 - Close of Day One

Day 2 - 2 July 2014

09.00 - Introduction & History of PV Inspection

10.15 - Risk Based Inspections

11.00 - Coffee

11.15 - The Pharmacovigilance Inspection Cycle

12.30 - Lunch

13.30 - Practical Exercise

15.30 - Tea

15.45 - Common Findings from Regulatory Inspections

16.30 - Final Discussion

16.45 - Close of Day One

For more information visit

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