Optimising Regulatory Development From Cradle To Grave

Optimising Regulatory Development From Cradle To Grave
Optimising regulatory development from cradle to grave - Ensuring the needs of special populations are met.


Date:
31 October 2018
Location: London, United Kingdom 



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.

Special Populations event 2020

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.

Working Party

  • Genevieve Le Visage, 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 Mendum, Associate Director, Global Regulatory Affairs, PRA Health Sciences, UK
  • Susan Bhatti, Director, EU Global Regulatory and Scientific Policy, Merck, Germany


How do I apply? 

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Course fees:
Type Member  Non-member 
Standard                   £550+VAT                 £675+VAT                          

 

Terms and conditions 

Please read the training terms and conditions before booking this meeting. By booking a place on this meeting you are agreeing to the training terms and conditions.



When
31/10/2018
Where
TOPRA 6th Floor, 3 Harbour Exchange Square London E14 9GE UNITED KINGDOM
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