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This masterclass will address the problems encountered during the creation of a PIP, as well as examining ways to overcome common challenges faced. The event will focus on the effects of a Paediatric Investigation Plan on the drug development landscape as a whole and will provide an in-depth overview into all perspectives of the PIP.

Attendees will be presented with current decisions from the EU Court of Justice and will have the opportunity to discuss PIP templates and documentation from the EMA website with an expert in the field, as well as considering current operational challenges when developing a PIP and finding solutions to overcome them
 

  • Analyse current EMA templates and documentation
  • Evaluate all perspectives of PIPs in drug development
  • Learn about novel decisions being made by the EU Court of Justice
  • Discover ways to improve your current approach and increase success
  • Debate with experts in the field, how best to overcome challenges in PIP development
  • Network with key industry executives in the field of paediatrics

 

Masterclass programme

9:00 Registration & Coffee

9:20 Welcome & Introductions

9:30 Background: US and EU Paediatric Legislation

10:15 Interactive Exercise: PIP Key Binding Elements on the EMA Website

11:00 Morning Coffee

11:30 Evaluating Perspectives on PIPs

12:15 PIP Decisions by the EU Court of Justice

12:45 Networking Lunch

13:45 Interactive Exercise: PIP Template and Related Documents on the EMA Website

14:45 Operational Challenges

15:30 Round Table Discussion

16:00 Conclusions

16:15 End of Masterclass

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Holiday Inn Bloomsbury

Coram Street
London WC1N 1HT
United Kingdom

Holiday Inn Bloomsbury

Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.

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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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