Speakers:

    • Rose Conference advisor:
      Dr. Klaus Rose
      F. Hoffmann-La Roche, Basel Switzerland
    • Mentzer Dr. Dirk Mentzer
      Head of Pharmacovigilance Unit
      Paul-Ehrlich-Institut, Member of PDCO, Germany
    • Horrigan Dr. Joseph Horrigan
      Director, Neurosciences Medicines Development Center Director, Medicines for Children Advisory Network
      GlaxoSmithKline plc, USA
    • Norjavaara Prof. Dr. Ensio Norjavaara
      Associate Prof.,Senior Research Physician, Clinical Pharmacology & DMPK
      AstraZeneca plc, R&D Mölndal, Sweden
    • Solomonidou Dr. Despina Solomonidou
      Global Franchise Head Oncology, Technical Research & Development – Project Management
      Novartis Pharma AG, Switzerland

For the complete speaker panel please see our brochure here.

PDCO Feedback – Challenges with PIPs – Harmonisation EMEA and FDA guidelines – Integrating paediatrics into development process

The development of paediatric medicines has experienced drastic changes over the last few years due to the EU regulation "Medicinal Products for Paediatric Use" of 2007. Since then the pharmaceutical industry has been forced to create new developmental strategies and invest in innovative methods for a safe and efficient development of paediatric medicines.

However, many challenges have not yet been mastered; companies find it hard to overcome hurdles with the PIP application process as well as the successful integration of paediatrics into the overall development process. Issues like global paediatric harmonisation and the importance and shortfalls of clinical trials are high on the list of priorities for pharmaceutical companies.

Discover new perspectives at our international conference Integrated Paediatric Drug Development and hear about the latest paediatric trends and international case studies:

  • Valuable feedback from the PDCO, BfArM and the pharmaceutical industry regarding PIP applications and when to expect a waiver or deferral
  • Crucial considerations for a global and integrated paediatric structure within a pharmaceutical company
  • The importance of an effective safety risk management in paediatric drug development and clinical trials

Profit from the opportunity to discuss the latest paediatric trends and international best practice case studies with experts from companies such as Pfizer, Astra Zeneca, Bayer Schering, Johnson & Johnson, Novartis, Baxter and many more.

Testimonials:

Very interesting- various topics regarding clinical research in children – very open discussion.
Anne-Laure Knellwolf, Admin. Direction, Italian National Institute of Research
Very informative overview of PIP
Julien Rongere, EU Regulatory Affairs Manager, Celgene International Sarl
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