EIPG Webinar: Development and Regulatory Approval of New Medicines for Children
Overview of Webinar
The webinar will compare the historical with the new approaches to the development of paediatric medicines and the aims of the Paediatric Regulation. This will include examples of Paediatric Investigation Plans (PIPs) and consideration of whether these new approaches are a success. The speaker is a member of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) and will discuss the benefits of conducting paediatric trials.
After attending this webinar, participants will:
- Understand the key aspects of the Paediatric Regulation.
- Be aware of the planning and approaches required for the development of paediatric medicines.
About the Speaker
John Watson has worked for four SME biotechnology companies as well as four larger pharma companies. His current employment is with Zogenix International as the Executive Director, Regulatory Affairs Europe, and the European regulatory lead for fenfluramine for the treatment of rare, paediatric epilepsy syndromes. John has vast experience in the strategy, preparation, submission, negotiation of approval and maintenance of medicines regulated using the EU centralised procedure including twenty Marketing Authorisations. He has planned, arranged and managed six Paediatric Investigation Plans (PIPs), a Paediatric Use Marketing Authorisation (PUMA), eight orphan drugs and many CHMP and national scientific advice procedures.
To Join the Webinar please register for the event by filling out the form. Further instructions will then be sent by e-mail.
A certificate of attendance will be issued after the webinar if requested upon registration, and if the evaluation form is completed. The session will be an
hour of Continuing Education.
EIPG järjestää webinaarin yhteistyössä PIER:in ja Univerisity College Corkin kanssa. Farmasialiitto on EIPG:n jäsen, joten myös Farmasialiiton jäsenet voivat osallistua webinaariin.
Paikka ja aika
Alkaa 01.11.2017 klo 18:00
Loppuu 01.11.2017 klo 20:00