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 GCP legislation can be harsh. Recently, risk based inspections have been introduced which provide a new set of challenges. This masterclass will provide you with the tools necessary to prepare for a successful MHRA Inspection.
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Completing Summary of Pharmacovigilance Systems (SPS) documents
Making an inspection checklist
Strategies and hints for the Inspection
Responding to Inspection findings
Keith Cormack 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 Potter's 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 two MHRA pharmacovigilance inspections for clients. Keith has also conducted several audits for clients in the past two years.
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SMi have had an established portfolio of Pharmaceutical, Defence, Energy, Finance and PPP/PFI events running since 1993. We are at the forefront of linking businesses with information, organising over 150 Conferences, Workshops and Masterclasses every year. All our events are research driven and highly targeted towards senior level professionals, designed to help you make informed decisions and remain at the cutting edge of business information.