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Overview

MHRA Inspections are an integral and expensive part of modern Pharmacovigilance. It is vital for any company that a good result is achieved as the penalties for non-compliance 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.

 


 Key Topics

  • Completing Summary of Pharmacovigilance Systems (SPS) documents
  • Making an inspection checklist
  • Strategies and hints for the Inspection
  • Responding to Inspection findings

 


 About the Workshop Leader

 

 

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.

 


 About the Organisation

 

 

  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.

 


 

 

Masterclass programme

13:30 Registration and Coffee

14:00 Welcome and Introduction

14:10 Risk based Inspections

14:50 MHRA inspection checklist

15:30 Afternoon Tea

15:50 Strategies and hints for the Inspection

16:30 Discussion session

17:00 Close of masterclass

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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