Navigating Paediatric Plans in the EU & US

We invite you to watch a replay of an exclusive webinar, created in partnership with TOPRA, ‘Navigating Paediatric Plans in the EU & US’.

Join our regulatory experts as they explore key aspects of paediatric plans in the EU and US including insights from a former regulator. 

In this webinar, you will:

• Gain an understanding of paediatric requirements in the EU, how these differ to the US, and implications for global programmes.
• Get an overview of keys aspects of the paediatric plan and how these are prepared.
• Learn a regulatory assessor’s perspective on paediatric plans and successful agency negotiations.

Karl-Heinz Huemer, MD, PhD is a clinical assessor at the Austrian Medicines & Medical Devices Agency and a delegate in the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency. Since 2023 he is working as a regulatory & scientific consultant.

Delphine Wagner, PhD has 20 years’ experience working in Global Regulatory Affairs. At Clinigen, she provides regulatory expertise and leadership to clients on a range of projects including regulatory applications in Europe, US and EU National Competent Authorities and advises clients on regulatory strategy for early to late-stage development assets.

Gerry McGettigan is a founder of the European regulatory affairs and product development consultancy company, as well as of Kinesys Consulting, recently acquired by Clinigen in 2024. Gerry has over 30 years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development.