Interactive Workshoday: Wednesday, 2nd June 2010

• Workshop A: Best practices: Successfully designing PIPs in line with EMEA regulations
• Workshop B: Integrating paediatrics into the mainstream drug development process
• Workshop C: Key considerations for developing a global pediatric development plan adhering to EMA and FDA guidelines
• Workshop D: Development of a paediatric safety specification

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9:00 – 12:00 Workshop A: Best practices: Successfully designing PIPs in line with EMEA regulations

The results according to an agreed PIP serve as a basis for approval. Therefore the plan has to be carefully developed including deferrals and waivers. During this workshop, we will take a closer look at the following aspects by discussing:

• Alignment of the Project Plan and the PIP
• Design and timing of a PIP
• Interaction with PDCO
• Waiver & deferrals

Dr. Laila Narouz-Ott
Global Regulatory Strategist
Bayer Schering Pharma AG, Germany

9:00 – 12:00 Workshop B: Integrating paediatrics into the mainstream drug development process

This interactive workshop will focus on the strategic aspects of initiating a paediatric development program. Furthermore, it will touch upon some of the operational aspects of getting PIP submitted and approved by the EU Health Authorities: The participants will have the opportunity to discuss on the basis of a case study, the project opportunities and draw-backs.

• Key considerations of developing a paediatric structure
• Time lines and logistical framework
• Project management aspects

Dr. Despina Solomonidou
Global Franchise Head Oncology, Technical Research & Development – Project Management
Novartis Pharma AG, Switzerland

13:00 – 16:00 Workshop C: Key considerations for developing a global pediatric development plan adhering to EMA and FDA guidelines

Pharmaceutical companies of any size are faced with the challenge of establishing submitting a realistic and scientifi cally sound development proposal fi rst to EMA and later to FDA. Within this framework, there are many pitfalls and challenges. Find out which strategies have proven successful and what can be learned from them.

• Key consideration on timing of PIP submission to EMA and pediatric plan submission to FDA
• Coordinating and setting up pediatric trials on your own or through experienced CRO’s
• Feedback from experience and case studies

Dr. Klaus Rose
Head of Paediatrics
F. Hoffmann-La Roche, Basel Switzerland

13:00 – 16:00 Workshop D: Development of a paediatric safety specification

The safety risk management of paediatric medicines is a crucial component in the paediatric drug development process. Understand the benefit risk of a given paediatric project and develop an appropriate safety specification for the safety risk management plan.

The following factors are considered:

• Identifying an appropriate indication
• Impact of paediatric age groups
• Impact of the adult safety specification

Dr. Stephen Heaton
Head of Safety Risk Management Planning and Coordination/Global Pharmacovigilance
Bayer Schering Pharma AG, Germany

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