June 25th, 2014 – 11:00 am EST
Voisin Consulting Life Science - 3, rue des Longs Prés 92100 Boulogne

VCLS Webinar Series

Paediatric Investigation Plan:

Requirements, process, and comparison with US PSP

Presenters: Delphine Kazancigil, Ljiljana Milosevic-Kapetanovic & Camille Shore

Date:          June 25, 2015

Duration:    45 Minutes

Time:          5pm CEST / 11am EST / 8am PDT

How to address European paediatric requirements, and coordinate development with the US market?

A Paediatric Investigation Plan is on the critical path to obtain market approval in Europe, even if the condition does not occur in children. A PIP must be agreed with regulators before submitting a Marketing Authorization Application. If PIP requirements can be waived or deferred under specific circumstances, the negotiation process takes up to a year.

In the US, a Paediatric Study Plan must be submitted not later than 60 after the end-of-phase 2 meeting. Such a requirement can also be waived or deferred. How does the PSP process compares with the EU PIP, and can both be coordinated?

The webinar covered:

  • Understanding of PIP requirements

  • Obstacles and approaches to successful PIP submission

  • Regulatory assessors’ perspective

  • PIP implications and timelines

  • Comparison with US PSP

About the presenters:

Delphine Kazancigil, is a Director at Voisin Consulting Life Sciences, with extensive experience in the design and implementation of regulatory strategies for the clinical development and registration of drugs and innovative medicinal products. Delphine has in particular gained significant experience in following through PIPs with regulators..

Ljiljana Milosevic-Kapetanovic, is a Medical Director at VCLS. A paediatrician, Ljiljana brings 15 years of experience as an assessor for the French regulatory agency, including the review of PIPs submitted to the European Medicines Agency.

Camille Shore, is a Senior Director providing US FDA regulatory strategic advice from early stage product development through post-marketing. With more than 30 years of experience working with biotech start-ups as well as large pharma companies, Camille ensures a consistent approach between regulatory submissions across the world.

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