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
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.