TMCnet News
Research and Markets: Pharmacovigilance Audits and Inspections - New Meeting (Course, London)DUBLIN --(Business Wire)-- Research and Markets (http://www.researchandmarkets.com/research/226vfw/pharmacovigilance) 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:
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 http://www.researchandmarkets.com/research/226vfw/pharmacovigilance |
