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SESSION 3
Session Chair(s)
Tomas Salmonson, DrMed, PhD
Partner
Critical Path Institute, United States
This session will look at 3 key ICH efficacy topics. It includes scientific and technical advances in paediatric drug development being addressed in the context of the Addendum to E11, including methodological aspects, commonality of content in plans for paediatric drug development, considerations on extrapolation, and paediatric formulations. It will also review the innovative approaches to good clinical practices (GCP), which are currently being harmonised as an Addendum to Guideline ICH E6. The final topic looks at advances made in harmonising multi-regional clinical trials (MRCTs). This work stream has the final goal of promoting appropriate conduct of MRCTs, resulting in further use of data from MRCTs in the various regions and better regulatory decisions.
Speaker(s)
E11 Clinical Investigation of Medicinal Products in the Paediatric Population
Dirk Mentzer, DrMed, MD
Paul-Ehrlich-Institut, Germany
PDCO Chair 2013-2019; Head of Pharmacovigilance Unit
E6 Addendum on Good Clinical Practice
Fergus Sweeney, PhD
European Medicines Agency, Netherlands
Head of Clinical Studies and Manufacturing Task Force
E17 Multi-Regional Clinical Trials
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
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Ways to register
Government/academia/charitable/non-profit (full time) employees are welcome to attend this event free of charge.
GOVERNMENT/ACADEMIA/CHARITABLE/NON-PROFIT (FULL TIME) attendees are kindly requested to fill out the registration form available at the back of the programme (click on View PDF) and send it to diaeurope@diaeurope.org.
Please note that there are limited places available for government/academia/charitable/non-profit attendees.
INDUSTRY attendees are kindly requested to register online or by filling out the registration form.
Registration fee includes delegate material and morning coffee break.
This event has limited capacity. Register early!