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Overview of this event:
MHRA pharmacovigilance inspections exist in order to ensure legislation and guidelines relating to drug safety monitoring are adhered to. It is vital for any company that a good result is achieved in inspections and the penalties for failing to comply with pharmacovigilance legislation can be harsh. This masterclass will provide you with the tools necessary to prepare for a successful MHRA Inspection.
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Key topics to be covered:
- Completing Summary of Pharmacovigilance Systems (SPS) documents
- Making an inspection checklist
- Strategies and hints for the Inspection
- Responding to Inspection findings
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About the Masterclass leader;
 Keith Cormack
Keith has worked in pharmacovigilance for ten years and has been involved in numerous regulatory authority inspections. His career began in Merck Generics in 2000 at the Potters Bar site which was responsible for global generic pharmacovigilance for the group. In the next eight years with the company he was involved in virtually all aspects of pharmacovigilance and was eventually responsible for compliance within the group, including involvement in the pharmacovigilance auditing of affiliates. In 2008, Keith joined Diamond PV Services as Pharmacovigilance Director and is involved in all aspects of pharmacovigilance for a wide variety of companies. He is currently QPPV for several companies and has fronted four MHRA pharmacovigilance inspections for clients. Keith has also conducted numerous audits for clients over the past 3 years.
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About the Organisation:
 Diamond PV Services Ltd
Diamond PV Services Ltd is a pharmacovigilance consultancy company which was founded in June 2007. It is part of the Diamond Pharma Services group of Companies which also includes Diamond Biopharm Ltd (Regulatory), Diamond Compliance Ltd and Diamond Clear PILs Ltd. The staff of Diamond PV Services have extensive and wide experience in the areas of European pharmacovigilance, medicine and Good Clinical Practice. (GCP). Their expertise extends into both the clinical and post market arenas. Diamond PV Services aim to provide a comprehensive PV service, including a Qualified Person for Pharmacovigilance (QPPV), which can be tailored to suit the needs of individual companies exactly.
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