Overview of the Paediatric Investigation Plan (PIP) procedure, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs, case-studies and instructor-led group work on specific cases.
This course will provide a full introduction to PIPs and the EU Paediatric Regulation. The course faculty are European-based leading experts from EMA and industry. Topics will be presented through interactive lectures and hands-on workshop training.
What You Will Learn
- EU paediatric regulation
- PIP lifecycle
- How to get your PIP approved
- PIPs after approval
Who Should Attend
Professionals in regulatory affairs, clinical research, project management, toxicology, product development. Participants should preferably have a fair understanding of aspects of paediatric medicines development.
At the conclusion of this course, participants should be able to:
- Describe the EU paediatric regulation
- Discuss the PIP approval procedure
- Identify the expectations and requirements from the Paediatric Committee (PDCO)
- Demonstrate how to prepare a PIP eligible for evaluation by PDCO
- Explain the modification of an agreed PIP procedure
- Describe the compliance check procedure
- Demonstrate an overview of procedures after initial PIP approval
Hotel & Travel
The DIA has blocked a limited number of rooms at the following hotel:
Hotel Mercure Amsterdam aan de Amstel
Joan Muyskenweg 10
1096 CJ Amsterdam
Tel.: +31 20 72 19176
Fax: +31 20 69 48735
at the rate of 139.00 EUR per single room per night inclusive of breakfast, exclusive of city tax.
To reserve a room, please use this booking form.
Important: Please complete your reservation by 15 February 2013. Reservations received after this date will be subject to hotel availability and room rate may vary.
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52