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Paediatric Investigation Plans (PIP)


Wednesday, June 1, 2016 - Thursday, June 2, 2016
Holiday Inn London Kensington
London, United Kingdom

http://atnd.it/41082-1

Event Type: Conference

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 participants from previous course say:"One feels confident to take on PIP related tasks!""Congratulations for this programme! I enjoyed it a lot""Very good presenters, who responded to our questions""Very useful course. Will help me in practical cases very soon"What You Will Learn EU paediatric regulationPIP lifecycleHow to get your PIP approvedPIPs after approvalWho 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.Level: Beginner/IntermediateLearning Objectives At the conclusion of this course, participants should be able to:Describe the EU paediatric regulationDiscuss the PIP approval procedureIdentify the expectations and requirements from the Paediatric Committee (PDCO)Demonstrate how to prepare a PIP eligible for evaluation by PDCOExplain the modification of an agreed PIP procedureDescribe the compliance check procedureDemonstrate an overview of procedures after initial PIP approvalParticipants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

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