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
There will be an assessment at the end of the course: 40 multiple choice questions, 30 minutes
Hotel & Travel
The course will take place at:
Millennium Gloucester Hotel London Kensington
4-18 Harrington Gardens
London, SW7 4LH
Tel: +44 20 7373 6030
Fax: +44 20 7373 0409
A limited number of rooms are available at a special rate of £ 145.00 per single and £ 155.00 per double room including breakfast and VAT. DIA rate is guaranteed until 31 March 2014, or until the room block is sold-out, whichever comes first. Attendees should make reservations as soon as possible.
To make your booking, go to www.millenniumhotels.co.uk/millenniumgloucester and insert the code LOND130514 in "Enter Code" field.
4051 Basel, Switzerland
Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52