Overview of the Paediatric Investigation Plan (PIP) procedure, including in-depth discussion of specific scientific/regulatory issues in relation to PIPs will be discussed. Case-studies and instructor-led group work on specific cases will be presented.
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 the participants from previous PIP courses say:
"Workshop and case studies were very appropriate to put in practice the information learned in the course, coverage of all main topics of Paediatric Regulation was excellent"
"Very knowledgeable and good instructors, great course"
"I appreciated the real-life examples brought up – the more the better!"
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
Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.
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
After 31 March the hotel rooms are subject to availability. Please contact the hotel for availability and prices.
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52