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Holiday Inn Amsterdam - Arena Towers

2023 年 11 月 15 日 8:30 上午 - 2023 年 11 月 16 日 4:30 下午

Hoogoorddreef 66a, 1101 BE Amsterdam, Netherlands

Paediatric Investigation Plans

This face-to-face training course led by experts in the Paediatric field, presenting regulatory as well as service provider perspectives will provide a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation.

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概览

This face-to-face training course will provide a full introduction to Paediatric Investigation Plans (PIPs) and the EU Paediatric Regulation. The course faculty are European-based leading experts
from European Medicines Agency and industry.

Topics will be presented through interactive lectures and hands-on workshop training.

 

精选主题

  • Definitions, Regulation, Guidelines
  • PIP Lifecycle: Preparation, submission, modifications
  • Global Paediatric Plan
  • PIP Opinion
  • Special issues: Pharmaceutical forms and formulations, non-clinical studies, clinical studies

 

谁应该参加？

This training course is designed for professionals in regulatory affairs, clinical research, project management, toxicology, and product development.

Participants should preferably have a fair understanding of aspects of paediatric medicines development.

Level: Intermediate

 

学习目标

  • 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
  • Prepare a global plan in compliance with EU, US and UK requirements
  • Recognize expectations for Covid19 PIPs

 

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