PDCO perspectives & proposals Enpr-EMA coordinating group - - PowerPoint PPT Presentation

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pdco perspectives proposals enpr ema coordinating group
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PDCO perspectives & proposals Enpr-EMA coordinating group - - PowerPoint PPT Presentation

Nov 17, 2022 118 likes •185 views

PDCO perspectives & proposals Enpr-EMA coordinating group Angeliki Siapkara, Marek Migda June 2018 An agency of the European Union PDCO needs for input from Enpr-EMA/ netw orks GENERAL I SSUES Changing/ emerging paediatric

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An agency of the European Union

PDCO perspectives & proposals Enpr-EMA coordinating group

Angeliki Siapkara, Marek Migdał

June 2018

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PDCO needs for input from Enpr-EMA/ netw orks

GENERAL I SSUES

  • Changing/ emerging paediatric therapeutic needs
  • Positioning among several ongoing/ upcoming developments

− Prioritisation − Strategic planning for similar drugs to address different indications

  • Methodological expertise

− Study designs, outcome parameters, novel approaches, scientific basis of

extrapolation.

  • National restrictions/ requirements : CTAs / ETs
  • Feasibility (in the context of above)
  • Input on Regulatory Guidelines

Meaningful PIPs  relevance + acceptability

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Exam ples of interaction

  • Rheumatology : Old vs. new -> networks input needed?
  • change of SoC since many biols now approved in children.
  • New emerging class(es) (for example JAKs)
  • Still withdrawal trial design – is use of placebo possible?
  • extrapolation could be an option but when ?
  • PDCO appreciates dialogue with networks (currently one

network at PDCO every other month)

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W ays of interaction

  • I ncrease netw ork capacities : invite regulators for training w ith

the aim of better understanding of licensing requirem ents.

  • Stream line PDCO feedback for specific products w ithin strict

PI P tim elines

  • consolidated “independent” network feedback within timely manner
  • If network identifies serious issues with a PIP trial -> encourage

sponsor/ PIP applicant to feedback to PDCO promptly, including network perspective on solutions.

  • More inform ation and transparence on Netw orks’ conflict of

interests.

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W ays of interaction

  • I nternational research collaborative approach.
  • Strategic collaboration of PDCO with on going network initiatives
  • Networks working collaboratively with other networks: e.g. infectious

disease network PENTAi with existing neonatology networks for antibiotic studies in neonates

  • Therapeutic areas w here Enpr-EMA netw orks are still

m issing ( for exam ple CV)

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