9:30 Registration and coffee

10:00 Feedback from the European regulator: EU Paediatric Regulation – Experience with PIP

• General aspects of PIP applications
• Specific challenges with presentation of paediatric development
• Role of paediatric pharmacovigilance in PIPs
• Summary of 3 years PDCO experience
• Conclusion and open issues

Dr. Dirk Mentzer
Head of Pharmacovigilance Unit
Paul-Ehrlich-Institut, Member of PDCO, Germany

10:40 Through the eyes of the industry: Impact of the EU regulation on the paediatric drug development process

• Paediatric homework and required resources
• Development functions involved in paediatric drug development
• Paediatric Investigation Plan (PIP): Preparation, negotiation with EMEA & PDCO, execution, report(s), compliance check

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

11:20 Coffee break and networking

11:50 The German regulatory perspective: PDCO and PIP – Responsibilities of Member States (national competent authority)

• Competence of PDCO
• Paediatric Investigation Plan – Update
• Responsibilities of Member States competent authority

Dr. Birka Lehmann
Director and Professor, Head of Licencing Division 3
Federal Institute for Drugs and Medical Devices, Germany

12:30 PANEL DISCUSSION: "Expectations versus reality": Addressing the challenges with PIPs, deferrals and waiver applications

The EU regulation, which entered into force in Januar 2007, has had an important positive effect on paediatric drug development. However, companies have experienced diffi culties with numerous issues when applying for a PIP, deferral or waiver. This discussion shall highlight the existing discrepancies and discuss a way forward.

Chaired by:

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

Discussion Panel:

13:10 Networking Lunch

14:40 Addressing the needs for a global paediatric development strategy conforming to both FDA and EMEA regulations

• The legislation – Considering different regulations for paediatric drug development
• High level strategy for a global paediatric programme
• Regulatory differences between the US and EU in global paediatric programmes

Prof. Dr. Ensio Norjavaara
Associate Prof., Senior Research Physician, Clinical Pharmacology & DMPK
AstraZeneca plc, R&D Mölndal, Sweden

15:20 Compliance check: Fulfi lling all the PIP criteria?

• Compliance check procedure
• Who will do it?
• What will be checked?
• When it will be done?
• Not compliant

Jacek Bedkowski
Senior Regulatory Affairs Associate
BAXTER World Trade SPRL, Belgium

16:00 Coffee break and networking

16:30 Request for modification of an agreed PIP

• When is a request for modifi cation needed?
• What procedural aspects (including timelines) need to be considered?
• Justifi cations for modifications

Dr. Corinna Weidt
Global Regulatory Strategist
Bayer Schering Pharma AG, Germany

17:10 Translating a PIP into a clinical trial – Experience in Germany

• Experience from the authorisation process at the competent authorities in Germany
• Experience from the validation process at the ethics committees in Germany
• Problems with the expectation from the PDCO and the "German perspective"
• Influences on the trial and the compliance check

Dr. Thorsten Ruppert
Senior Manager, Strategic Issues Research/Development/Innovation, VfA
Germany

17:50 ROUND TABLE DISCUSSIONS:

Challenges with the design and applications of PIPs

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

Orphan drugs: From designation to marketing authorisation

Dr. Carlos Camozzi
Medical Director, Head of Medical Department
Orphan Europe, France

Off-label use and impact on clinical trials

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