Hotel NH Amsterdam City Centre , Netherlands, Amsterdam
Apr 23 2012 8:00AM - Apr 24 2012 4:30PM
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. KEY TOPICS - EU paediatric regulation
- PIP lifecycle
- How to get your PIP approved
- PIPs after approval
CONTINUING EDUCATION
DIA meetings and trainings are generally approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available
Learning Objectives:
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
Event Code:
12580
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