Experimental Medicine Training Initiative
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Cambridge University
Cambridge University

 

Paediatric Drug Development

08/10/2018 to 08/10/2018


To understand paediatric drug development in experimental medicine research and as part of clinical studies.

Gain an overview of differing disease epidemiology and regulatory considerations, understanding conditions which occur in paediatric populations & adult populations.

To understand the difficulties in managing a paediatric plan for ACS indication & alternative approaches

Programme

Day 1 | Monday 08 October 2018


Time Item
08:30 to 09:00 Registration
09:00 to 09:30 General overview of paediatric drug development
Professor Steven Cunningham, Professor of Paediatric Respiratory Medicine, Centre for Inflammation Research, University of Edinburgh
09:30 to 10:00 Paediatric Investigation Plans
Dr Phil Ambery, Global Clinical Leader, Diabetes, Astra Zeneca
10:00 to 11:15 Pharmacokinetic and pharmacodynamic considerations in paediatric drug development
Marcella Petrone and Paul Baverel Principal Clinical Pharmacokineticist, MedImmune
11:15 to 11:30 Break
11:30 to 12:00 Paediatric clinical trials - a regulatory perspective
Dr Eleni Gaki, Medical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA)
12:00 to 12:30 Regulatory considerations in paediatric drug development- an industry perspective
Ms Rhiannon Davies, Global Regulatory Affairs Director, Astra Zeneca
12:30 to 13:30 Lunch
13:30 to 14:00 Paediatric Vaccine Development
Dr Otavio Cintra Head of Scientific Affairs and Public Health, Vaccines Global Medical Affairs GSK
14:00 to 15:00 Difficulties in running a paediatric plan for ACS indication - Alternative approaches
Workshop
15:00 to 15:15 Break
15:15 to 16:00 Debate- This house believes that paediatric trials are impossible to conduct in Type 2 diabetes For: Dr Phil Ambery Against: Dr David Dunger
Debate and Vote
16:00 to 17:00 Closing comments, end and networking

 

Meeting Details

  Venue
Robinson College

  CPD Points
0

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Forthcoming Meetings

Paediatric Drug Development

08/10/2018 to 08/10/2018

To understand paediatric drug development in experimental medicine research and as part of clinical studies. Gain an overview of differing disease epidemiology and regulatory considerations, understanding conditions which occur in paediatric populations & adult populations. To understand the difficulties in ...

 

 

 

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