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This is a practical workshop aimed at all personnel involved in PV inspections. It will cover the concept of Inspection Readiness not just for the PV department but for the entire company; before, during and after the inspection. Topics that will be covered include logistics, communication – both internal and external, document preparation and interview preparation. We will introduce handy tools and processes to aid inspection management.

 


Workshop Agenda:

  • Introduction to Inspection Readiness
  • Tools for managing PV inspections
  • Inspection Do's and Don’ts
  • Interview preparation

About the Workshop Leader:

 

Colin Knight is a pharmacovigilance scientist with over 30 years of varied industry experience in different therapeutic areas including CNS, ophthalmology, wound-healing and pain. At AstraZeneca Colin was responsible for providing pharmacovigilance input into global study teams. This included developing processes which facilitated the collection of SAE safety data from clinical studies using Web Based Data Capture (WBDC) systems whilst ensuring that compliance with regulatory reporting to competent authorities was not impacted. More recently he worked with a global team involved with the development of an in-house safety database. In addition, he has direct experience of converting legacy safety data from several coding dictionaries into the MedDRA dictionary. Colin has a special interest in Data Safety Monitoring Boards (DSMB) and has given external presentations on industry perspectives of DSMB at academic meetings.
 


About the Organisation:

 

  TranScrip Partners is a partnership of pharmaceutical professionals offering a wide range of expertise in drug development and commercialisation. Our team consists of highly skilled, experienced Senior Partners and Partners, supported by Associates. Working across a wide range of pharmaceutical sub-disciplines and therapeutic areas, TranScrip Partners have a powerful commitment to lasting high performance through the continuity of the partnership

 


 

Workshop programme

8:30 Welcome and Housekeeping notices

8:40 Individual objectives for the Workshop

8:50 Icebreaker activity

9:10 Inspection Readiness – preparing for the Inspection

9:50 STOP!! Just a minute!!!

10:05 How to manage the Inspection

11:00 STOP AGAIN!! Just a minute!!!

11:15 Coffee break

11:30 After the Inspection: what next?

12:00 Workshop Summary and key learnings

12:15 Workshop follow-up

12:20 Q&A

12:30 Close of workshop

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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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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