The role role of the of the Paediatric Paediatric Committee - - PowerPoint PPT Presentation

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The role role of the of the Paediatric Paediatric Committee - - PowerPoint PPT Presentation

May 19, 2023 566 likes •768 views

The role role of the of the Paediatric Paediatric Committee Committee The and short history history of of previous previous activities activities and short Paolo Rossi I talian Delegate at PDCO Chairman Dept. of Paediatrics

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EMEA Workshop on European Paediatric Network

The The role role of the

  • f the Paediatric

Paediatric Committee Committee and short and short history history of

  • f previous

previous activities activities Paolo Rossi

I talian Delegate at PDCO

Chairman

  • Dept. of Paediatrics

University of Rome Tor Vergata Children’s Hospital Bambino Gesù Rome,Italy

1st EMEA Workshop on European Paediatric Network EMEA, London 16 February 2009

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EMEA Workshop on European Paediatric Network

Think different

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EMEA Workshop on European Paediatric Network

Agenda Agenda

  • The role of PDCO

The role of PDCO

  • PEG

PEG

  • EU Paediatric Network

EU Paediatric Network

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EMEA Workshop on European Paediatric Network

Outline Outline

  • The role of PDCO

The role of PDCO

  • PEG

PEG

  • EU Paediatric Network

EU Paediatric Network

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EMEA Workshop on European Paediatric Network

Paediatric Committee Paediatric Committee -

  • PDCO

PDCO

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EMEA Workshop on European Paediatric Network

Main Main roles roles of PDCO

  • f PDCO

Opinions on PI Ps and Deferrals, Waivers Opinion on compliance with PIP Opinion on Quality, Safety and Efficacy on

request from CHMP (marketing authorisations, scientific advice)

Other task: Survey format and content and Paediatric

Needs

Network(s) Eudra CT

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EMEA Workshop on European Paediatric Network

Paediatric Investigation Plans Paediatric Investigation Plans

Details of timing and measures proposed (i.e

studies, trials and pharmaceutical development) necessary to obtain a paediatric indication with an age appropriate formulation in all paediatric subsets affected by the condition

Quality Safety Efficacy

Marketing Marketing Authorisation Authorisation criteria criteria

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EMEA Workshop on European Paediatric Network

Timing of PIP application Timing of PIP application (new products) (new products)

1 Non-clin Phase 1 Phase 2 Phase 3 Post approval

  • Paed. Investig. Plan

Compliance Deferral Waiver

PIP Amendments Paediatric Committee MA CTA CTA SA

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EMEA Workshop on European Paediatric Network

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EMEA Workshop on European Paediatric Network cardiovascular diseaseas Anaesthesiology Dermatology Diagnostic&pulmonology Endocrinology/ gynaecology/ fertility/ metabolism Gastroenterology Hepatology Haematology- Hemostaseology Immunology rheumatology/ transplantation Infectious diseases Neurology Nutrition Oncology Ophthalmology Pain Pneumology Psychiatry Uro-nephrology Vaccine

PIP'S THERAPEUTIC FIELDS

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EMEA Workshop on European Paediatric Network

Outline Outline

  • The role of PDCO

The role of PDCO

  • PEG

PEG

  • EU Paediatric Network

EU Paediatric Network

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EMEA Workshop on European Paediatric Network

PEG PEG – – Paediatric Working Party Paediatric Working Party

(previous Paediatric Expert Group) (previous Paediatric Expert Group)

The PEG was established in order to coordinate the necessary actions and to advise the EMEA and CHMP on all questions relating to the development and use of medicinal products in children.

Tasks:

  • assessing, by therapeutic areas or conditions, a public health need or unmet medical need (paediatric

use and available paediatric formulations) Update of Paediatric needs (in 2009) by PDCO;

  • ne updating in 2007 by PDCO
  • preparing, reviewing and updating guidelines to facilitate the development of paediatric products
  • providing expert advice on paediatric issues to support the evaluation of centralised marketing

authorisation applications and the preparation of scientific advice;

  • providing advice on paediatric issues to the EMEA's scientific committees, the European Commission

and other groups;

  • liaising with interested parties, particularly children's and patients' organisations, with a view to

encouraging the creation of research networks for the development of medicines.

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EMEA Workshop on European Paediatric Network

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EMEA Workshop on European Paediatric Network

Outline Outline

  • The role of PDCO

The role of PDCO

  • PEG

PEG

  • EU Paediatric Network

EU Paediatric Network

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EMEA Workshop on European Paediatric Network

EMEA Paediatric Research Network EMEA Paediatric Research Network

Objectives:

Collaboration Building competences Avoiding unnecessary studies Stimulating high quality research Strengthening the foundations of the European

Research Area

Facilitation of recruitment in clinical trials

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EMEA Workshop on European Paediatric Network

Why Why PDCO PDCO is is important for EU important for EU paediatric paediatric network? network? PDCO

DEMAND OFFERI NG

deriving from new EU Regulation PIP – paediatric studies

how to connect?

Chosen by the Companies Driven by PDCO

NETWORKS NETWORKS

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EMEA Workshop on European Paediatric Network

PDCO as an “Coordinating Agency” PDCO as an “Coordinating Agency” (organization and transparency) (organization and transparency)

Why Why PDCO PDCO is is important for EU important for EU paediatric paediatric network? network? BENEFI TS

  • reduction in timing for recruiting patients
  • high quality of the planned studies (high standards of the Networks)
  • assess paediatric Needs and avoid the replication of the studies
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EMEA Workshop on European Paediatric Network

  • P. Picasso 1932
  • P. Picasso 1932 Il sogno

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