Event overview

Regulatory and HTA submissions must ensure that no special population is ‘left behind’. Regulators and patients need reassurance that clinical data and product information are relevant in any situation. But which are the populations that must be considered? What guidance is already available, how might it change and are there national variations in approach?

This meeting will explore the regulatory and practical clinical issues associated with paediatric populations, the elderly and obese patients. Expert presenters will discuss current guidance and future trends and workshop sessions will give participants the opportunity to explore where requirements of patient groups are common or divergent. Attendees will understand where there may be conflicts between regulatory needs and practical implementation and will discuss strategies to overcome those challenges.
 

Benefits to delegates

Attendees will understand where there may be conflicts between regulatory needs and practical implementation and will discuss strategies to overcome those challenges. You can also contribute by taking part in a short survey (3 minutes) which will help to initiate debate in the afternoon workshops - Please click here to complete the survey.

 
CPD: This course provides 8 CPD hours upon successful completion

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
 

Suitable for

This meeting is of value to regulatory professionals responsible for advising on clinical development strategies and data requirements now and in the future, as well as those responsible for generating the clinical evidence needed to ensure access of new therapies to the widest market. Thus this workshop is suitable for Regulatory personnel making new submissions in the EU and internationally (middle to senior levels), project managers, clinical research managers and directors, academia, clinical research networks (EnprEMA, paediatric eYPAGnet etc), patient groups, CRO, health charities and HTA’s.
 

Working Party

• Genevieve Le Visage, Head of EU Regulatory Intelligence and Policy, Novartis, Switzerland and Vice-Chair Paediatrics WG, EFPIA
• Mark Turner, Senior Lecturer in Neonatology, University of Liverpool, Chair, European Network of Paediatric Research at the European Medicines Agency
• Martine Zimmermann, Global Head of Regulatory affairs, Alexion, Switzerland
• Jo Dewhurst, Associate Director, Global Regulatory Affairs, PRA Health Sciences, UK
• Susan Bhatti, Director, EU Global Regulatory and Scientific Policy, Merck, Germany
  
  

Speakers

Mathieu Boudes European Patients Forum	Martine Dehlinger-Kremer Synteract	Virginie Hivert Eurordis	Geneviève Le Visage Novartis
Susan Morgan MHRA	Catherine Tuleu UCL School of Pharmacy	Katarina Vucic HALMED - Croatia	Martine Zimmermann Alexion

Programme