Paediatric Investigation Plans and Waiver

Track:
Medical Writing Regulatory Topics

Day & Time:
March 19, 3:30PM - 5:00PM

Room Number:
Kave Ballroom One

Type:
Session

Title:
Paediatric Investigation Plans and Waiver

Chair(s):
Matthias Dormeyer, PhD
Managing Director
MDC RegAffairs GmbH, Germany

Description:
Paediatric Investigation Plans (PIP) are a mandatory regulatory step to allow for marketing authorization in the EU. In such PIP it is described in detail how a medicinal product will be developed in the entire paediatric population. There are clear and important distinctions in the paediatric procedure in the EU compared to the US. In this session an overview of the regulatory background and details of the paediatric legislation in the EU will be given. In addition, the formal PIP procedure will be presented as well as detailed guidance how to draft a PIP including experience from an applicant point of view as well as Agency experience and expectations.

Learning Objective(s):
At the conclusion of this session, participants should be able to: - Explain the Paediatric Regulation in the EU and the role of Paediatric Investigation Plans - Describe the design of a Paediatric Investigation Plan that will be compliant with current regulatory guidance - Discuss how to organize a Paediatric Investigation Plan procedure

Presentation(s) & Speaker(s):
Faculty
Matthias Dormeyer, PhD
Managing Director
MDC RegAffairs GmbH, Germany

Faculty
Birka Lehmann, MD
Director and Professor, Head of EU & International Affairs
BfArM, Germany