Sponsored Webinar-Navigating Paediatric Plans in the EU & US

Sponsored Webinar-Navigating Paediatric Plans in the EU & US
FREE SPONSORED WEBINAR - In this webinar, Clinigen will provide an overview of the paediatric requirements in the EU, how these differ to the US, and offer the perspective of Dr Huemer, ex-Paediatric Committee member at the EMA, on how to overcome challenges when preparing paediatric plans, and successfully manage negotiations with the regulators. Our Clinigen specialists will also expand on the comparisons with the US. This is an interactive session where participants will be able submit questions live during the webinar.

2 April - 16:00 - 17:00 GMT / 11:00 - 12:00 EST / 17:00 – 18:00 CET
Navigating Paediatric Plans – EU and US considerations, including insights from a former regulator  

Sponsors wishing to submit a Marketing Authorisation Applications in the EU or US must comply with paediatric requirements and submit a Paediatric Plan as part of their application, or evidence that requirements can be waived. Paediatric plans must be agreed with regulators before submission, a process which can take up to a year, and, as such, paediatric plans are often on the critical path. The process and requirements differ between the EU and US, which adds complexity for Sponsors leading global programmes. In this webinar, we will provide an overview of the paediatric requirements in the EU, how these differ to the US, and offer the perspective of Dr Huemer, ex-Paediatric Committee member at the EMA, on how to overcome challenges when preparing paediatric plans, and successfully manage negotiations with the regulators. Our Clinigen specialists will also expand on the comparisons with the US. This is an interactive session where participants will be able submit questions live during the webinar. 
 
Learning outcomes:
• An understanding of paediatric requirements in the EU, how these differ to the US, and implications for global programmes
• An overview of keys aspects of the paediatric plan and how these are prepared
• A regulatory assessor’s perspective on paediatric plans and successful agency negotiations 
 
Target audience: Pharma and biotech professionals working in drug development and needing a paediatric plan in the EU and US.
 
Speakers:
 
Karl-Heinz Huemer, PhD.  M.D. studied both medicine and biology, and worked for over 20 years as a physiologist at the Medical University of Vienna. After completing his MD, he continued his medical specialisation in physiology with internships in clinical pharmacology and ophthalmology, while also being member of the ethics committee at the Medical University of Vienna. In 2007 he became clinical assessor at the Austrian Medicines & Medical Devices Agency, and was subsequently appointed as delegate in both the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency where he worked for 14 years. Since 2023 he is working as a regulatory & scientific consultant.
 
Delphine Wagner, Ph.D. 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. Delphine has experience in leading teams in executing regulatory submissions, and regularly engages with Agencies. Delphine has a PhD in Medicinal Chemistry from the University of Bath and has held post-doctoral research positions at Sanofi-Aventis and at the University of Oxford.
 
Gerry McGettigan has over 30 years' experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development, as well as in various Non-Executive Director roles. Gerry founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was acquired by a top 5 CRO in 2005. He subsequently founded Kinesys Consulting, recently acquired by Clinigen in 2024. Gerry has worked with many EU, US and other clients on projects ranging from early-stage regulatory strategy for emerging biotechs to advising on strategy and operations for major developments of large pharma firms. 

This webinar is sponsored by Clinigen



Disclaimer: Whilst TOPRA is running this webinar for Clinigen, this is not an endorsement of Clinigen, Clinigen's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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When
02/04/2025 16:00 - 17:00
Where
ONLINE
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