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Preparing a Paediatric Investigation Plan
27 January 2010
Preparing a Paediatric Investigation Plan

This workshop will be a hands-on exercise in the different stages of Paediatric Investigation Plan (PIP) preparation. Topics covered will include the steps of PIP negotiation with the EMEA and the PDCO, the challenges of PIP execution and reporting its results, and the challenges of getting the final reward. It will give practical tuition on how to scan the FDA and EMEA websites. It will also give a lot of scientific background information including which organisations offer help and which events should be attended.

 


Key Topics:

  • Paediatric Investigation Plan (PIP) preparation
  • The negotiation process
  • Competitive intelligence
  • Paediatric research networks
  • Practical challenges

About the Workshop Leader:

 

  Dr. Klaus Rose is a Principal Consultant at  Granzer Regulatory Consulting & Services and Former Head of Paediatrics at Roche Pharmaceuticals, a position which he held until November 2009. He qualified in medicine in Berlin and completed his postgraduate clinical training in General Medicine in Germany and England before joining the pharmaceutical industry in 1991. He is co-editor of the book Guide to Paediatric Clinical Research, the second edition of which is in preparation. He also serves as chairman to the EFGCP children’s medicines working party and as chairman to the IFPMA Pediatric Task Force

 


 

Workshop agenda

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8:30

Registration & Coffee

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9:00

Paediatric Homework: Essentials of Paediatric Investigation Plan (PIP) preparation

  • Epidemiology: EMEA class waivers / Frequency of paediatric diseases
  • Medical needs in children and currently available alternatives and safety concerns
  • Age-specific staggered approach to clinical testing in children
  • Non-clinical toxicology, modelling and simulation, paediatric formulations, paediatric clinical trials
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    10:00

    The PIP negotiation process with EMEA / PDCO (Paediatric Committee)

  • Letter of intent, negotiation, reporting, decision, compliance check for reward
  • Paediatric scientific advice
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    10:30

    Morning Coffee

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    11:00

    Competitive intelligence: EMEA and FDA paediatric websites

  • Interactive exercise: PDCO decisions on the EMEA website; details of paediatric development programs on the FDA website
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    11:30

    Where to find help: EU and US paediatric research networks, CROs, consultancies

  • European national paediatric research networks
  • European disease-specific paediatric research networks
  • US networks, CROs, consultancies
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    12:00

    Practical challenges in paediatric clinical trials

  • Physiology of the child’s developing body
  • Ethics committee’s concerns with paediatric studies
  • Parental informed consent and child’s assent
  • Logistical challenges
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    12:30

    Close of Workshop

    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:

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