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.

When: 11 April 2019
Where: TOPRA. 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE
Time: 09.00-16.45

Event overview

Special Populations stock photoRegulatory 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.

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


Mathieu Boudes

Mathieu Boudes

European Patients Forum
Martine Dehlinger-Kremer


Virginie Hivert

Virginie Hivert

Genevieve Le Visage

Geneviève Le Visage


Susan Morgan


Catherine Tuleu

UCL School of Pharmacy 

Katarina Vucic

HALMED - Croatia 
Martine Zimmermann

Martine Zimmermann



DOWNLOAD the event programme 

How do I apply? 

Simply log in or create an account and register below. 

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.

TOPRA 6th Floor, 3 Harbour Exchange Square London E14 9GE UNITED KINGDOM
Online registration not available.
Your VAT country
Your Vat number
If your company VAT number does not appear here or you would like to be invoiced using a different VAT number please email finance@topra.org

Register now

Our policy on photography and video

On occasions, TOPRA takes photographs and videos which may be used to help promote our conferences and courses (both online and in print). By purchasing a ticket to attend this meeting you are confirming that you are aware of this and have no objections to your image or voice appearing in any material issued by TOPRA after the meeting.

However, if for any reason you do not wish TOPRA to use your image or voice please let us know

Recording and photography by delegates is not permitted.