Videos of presentations from the Paediatrics Medicines Workshop on 15 September 2009 now available

On 15 September last year, a joint meeting between TOPRA, EFPIA, EBE and The European Medicines Agency on Paediatric Medicines took place in London, UK.

This meeting was set up to address the fact that the need to submit paediatric investigation plans (PIPs) has been a requirement for around 2 years and there have been many new procedures and processes to master to prepare a PIP and then to follow it through. This practical workshop enabled members of the paediatric committee (PDCO) to share with Industry through case studies what should be considered when preparing and writing a PIP.

Programme Committee consisted of:

  • Agnes Saint Raymond, EMA
  • Christine Lise Julou, EFPIA
  • Piers Allin, EBE
  • Ali Harrison, AstraZeneca
  • Angelika Joos, Merck Sharp & Dohme (Europe)
  • Gesine Bejeuhr, VFA, Germany
  • Christopher Bailey, TOPRA

Speakers included

  • Daniel Brasseur, Chair PDCO
  • Sonja Pumplün, Actelion Pharmaceuticals Ltd
  • Vibeke Viergard, Novo Nordisk
  • Péter Károlyi, Scientific Administrator, EMA
  • Jan Gross, Merck Serono, Germany

Chair for the day: Paolo M. Biffignandi, TOPRA President, CEO, VI.REL Pharma S.a.a., Italy

TOPRA has now made 5 of the key sessions available for download. Each session costs £40 or you can purchase all of them for £150.

The 5 sessions are:

Session 1: How to prepare the submission dossier? Procedural and scientific advice - practical aspects

Péter Károlyi, Scientific Administrator, EMA

Session 2: The Paediatric Regulation, an industry viewpoint based on experience from Novo Nordisk A/S

Vibeke Bjerregaard, Novo Nordisk A/S, Denmark

Session 3: Part C, D and E: Waivers, Study Plans, Deferrals-Where things can go wrong, potential problems and how to avoid them

Jan Gross, Merck Serono, Germany

Session 4: PIP Modification and Compliance - experiences to date

Péter Károlyi, EMA and Lisette Vromans, Schering Plough, the Netherlands

Session 5: Reports from Workshops, including Closing Remarks: Paolo M. Biffignandi, TOPRA President, CEO, VI.REL Pharma S.a.a., Italy

Moderated by Sonja Pumplün, Head Global Drug Regulatory Affairs, Actelion, Switzerland

For more information or to purchase any of the videos please go to http://www.topra.org/videos/video-training