Paediatric medicines – a practical workshop on the Paediatric Investigation Plan (PIP)

Paediatrics Workshop on 15 September Fully Booked - Waiting List available

The workshop on Paediatric medicines, which is a joint meeting between TOPRA , European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the European Medicines Agency (EMEA) is now fully booked. However, should you wish to be added to the Waiting List, please complete a booking form and return it by fax to: +44 (0) 207 537 2003.

For more information, you can also email TOPRA on meetings@topra.org or call on +44 (0) 207 510 2560.

A joint meeting between TOPRA , European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the European Medicines Agency (EMEA)

Aims

The need to submit paediatric investigation plans (PIPs) has now 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 will enable members of the paediatric committee (PDCO) to share with Industry through case studies what should be considered when preparing and writing a PIP. This meeting is for all those persons in regulatory affairs and medical departments who are seeking approval for PIPs or deferrals or waivers within Europe for what is now obligatory for all medicines, whether intended for children or not.

Programme Committee

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

Speakers

Invited members of PDCO, EMEA and Industry

Programme

Preparing for the PIP submission
This session will cover an overview of all necessary steps and investigations to accumulate sufficient information in preparation for the writing of a PIP dossier

• How to prepare the submission dossier – procedural and scientific advice – practical aspects
• Preparing for a PIP and specific content of the paediatric investigation plan – a joint effort in companies – Specific examples

Writing the PIP and getting it approved
This session will cover important aspects to consider for writing of parts C-E and successful interactions with EMEA and PDCO

• Part C, D and E: Waivers, deferrals – where things can go wrong – potential problems and how to avoid them. Issues from PDCO
• PIP Modification and Compliance – experiences to date

Workshop
This workshop will cover practical discussions on hypothetical case studies developed around important issues encountered in different procedures. Solutions and ways forward will be suggested. Delegates will be divided into groups of 10-15 and will discuss case studies with a panel comprising PDCO member, EMEA and industry expert per group.
Each workshop will report back to the whole meeting including learning points being published.

Registered participants are invited to send questions in advance of the meeting to TOPRA in order to include them in the discussions. Take Part in Our Survey