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Overview

In 2017, the DIA/EFGCP/EMA Annual Paediatric Conference will focus on how to optimise children’s access to new medicines.

With more than 10 years of the EU Paediatric Regulation, all parties involved in paediatric drug development (industry, regulators, academia, healthcare professionals and patients) have seen progress in developing new medicines for children.

This conference will explore how to build on the successes from the past 10 years of EU Paediatric Regulation, and how to overcome challenges that still exist.

 

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Day 1: 10 years of Paediatric Regulation: Lessons Learnt from All Stakeholders

  • Real world examples of what challenges are associated with different regulatory pathways and development scenarios as well as how to overcome them. Case studies will be presented to foster the discussion in rare diseases/small populations as well as oncology
  • Discussions on tools and methods appropriate to optimize drug development such as extrapolation
  • Concluding session on patient engagement within decision-making processes. What are patients’ groups expectations regarding availability of new medicines and how do they define benefit/risk?

 

Day 2: Looking Toward the Future

  • Updates from ongoing European and International initiatives related to paediatric, including clinical trials
  • Discussions on possible opportunities with the new European Clinical Trials Regulation when conducting paediatric clinical trials
  • Quest for solutions within paediatric pharmacovigilance with a view to promote shared understanding with all parties
  • Concluding sessions on exploring the future of children’s access to new medicines. Different stakeholders face different challenges that are unique to Europe, while paediatric medicines development is global. This session aims to promote a common understanding and alignment on important points from different stakeholders and will set the scene for future dialogue.

There will be a specific Q&A session with EMA on paediatric procedures. To this effect, questions for EMA and/or Paediatric Committee (PDCO) should be submitted by 20 September 2017 to Katja.Malec@diaglobal.org, to be answered by the Paediatric Medicines office at the EMA.

Who should attend?

  • Regulatory, clinical and drug development professionals from Health Authorities and Industry interested in paediatric drug development
  • Paediatricians, Representatives from Academia, Paediatric Societies and Networks
  • Employees from Clinical Research Organisations (CROs) involved in paediatric clinical trials
  • Any stakeholder interested in the development of better medicines for children

Learning objectives

  • To update participants on current paediatric regulatory requirements, scientific and operational success and challenges
  • To exchange experiences with regulatory authorities, academia and industry when developing medicines for children globally
  • To discuss visions, daily challenges and potential ways to move forward and further improve processes for paediatric drug development

Program Committee

  • Heidrun  Hildebrand
    Heidrun Hildebrand Global Program Head, TA Pediatric Development
    Bayer AG, Pharmaceutical Division, Germany
  • Mette  Due Theilade Thomsen, PhD
    Mette Due Theilade Thomsen, PhD Managing Director
    PIP Adviser, Denmark
  • Geneviève  Le Visage, PharmD
    Geneviève Le Visage, PharmD Head EU Regulatory Policy
    Novartis Pharma AG, Switzerland
  • Roberto  De Lisa, MD
    Roberto De Lisa, MD Paediatric Coordinator, Paediatric Medicines Office
    European Medicines Agency, European Union, United Kingdom
  • Janina  Karres, PhD
    Janina Karres, PhD Scientific Officer, Paediatric Medicines Office
    European Medicines Agency, European Union, United Kingdom
  • Dimitrios  Athanasiou, MBA
    Dimitrios Athanasiou, MBA Patient Advocate
    Muscular Dystrophy Association Hellas, Greece
  • Solange  Corriol-Rohou, DrMed, MD, PhD
    Solange Corriol-Rohou, DrMed, MD, PhD Senior Director, Global Regulatory Affairs & Policy, Europe
    AstraZeneca Global Medicines Development, France
  • Martine  Dehlinger-Kremer, PhD
    Martine Dehlinger-Kremer, PhD Vice President, Global Medical and Regulatory Affairs
    SynteractHCR Deutschland GmbH, Germany
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+41 61 225 51 51


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