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Conference Documentation: Paediatric Clinical Trials

Conference Documentation: Paediatric Clinical Trials

SMi is proud to present the 10th Paediatric Clinical Trials Conference, 16th – 17th March 2016, London. This event will look at the paediatric therapeutic developments, directives and procedures which have been put in place to protect children taking part in clinical trials.

Many treatments of today are the result of past clinical trials. The need for improving strategies in conducting paediatric clinical trials has never been greater. Even if the costs linked trials are not always affordable, pharmaceutical industries continue to expand their research.

A series of interactive conference sessions, roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to develop analgesics in paediatric population, implement a strategy regulatory partnership through collaboration, explore innovations in drug formulation, monitor and audit issues specific to paediatric research and utilize clinical pharmacology to model adult data to paediatrics.


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Klaus Rose, CEO, klausrose Consulting
9:10
Update of the frameworks of US and EU paediatric legislation
Klaus Rose, CEO, klausrose Consulting
9:50
Challenges in paediatric drug development - developing new oncology drugs for children
Sabine Fuerst-Recktenwald, Senior Medical Director Paediatric Oncology, Roche Pharma Schweiz AG
10:30
Morning Coffee
11:00
Panel Discussion: Paediatric microdosing
Esther Van Duijn, Scientist, TNO
11:00
Panel Discussion: Paediatric microdosing
Daniel Bar-Shalom, Associate Professor, University of Copenhagen
11:00
Panel Discussion: Paediatric microdosing
Klaus Rose, CEO, klausrose Consulting
11:40
Towards a better understanding of bioethics and paediatric drug development and clinical trials
Albert Allen, Medical Director, Eli Lilly And Company
12:20
Networking Lunch
14:00
Prelicensing strategies to support paediatric development
Karl-Heinz Huemer, Scientific Office, Austrian Agency for Health and Food Safety
14:40
Safety considerations of paediatric clinical trial
Robert Kahn, Senior Safety Science Leader, Genentech
15:20
Afternoon Tea
15:50
Children on the move: Travel, trials and tests
David McIntosh , Honorary Clinical Senior Lecturer - Imperial College London, Imperial College
16:30
Chairman’s Closing Remarks and Close of Day One
Klaus Rose, CEO, klausrose Consulting
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Klaus Rose, CEO, klausrose Consulting
9:10
Paediatric drug development, a bottom up approach with the SAFEPEDRUg-project
Johan Vande Walle, Professor in Paediatric Nephrology, University Hospital Ghent
9:50
Development of bosentan in paediatric PAH patients with modeling support
Martine Gehin, Clinical Pharmacologist, Actelion
10:30
Morning Coffee
11:00
Formulation challenges in paediatric drug development
Daniel Bar-Shalom, Associate Professor, University of Copenhagen
11:40
Why paediatric development does really matter? Psychopharmacology as a paradigm
Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck
12:20
Networking Lunch
13:30
Challenges of drug development in rare diseases - inhalation anthrax
Sangeeta Sedani, Clinical Investigation Lead, GlaxoSmithKline R&D
14:10
Networking in paediatric oncology
Ellen Bolotin, Global Clinical Leader in Paediatrics , Bayer Corporation
14:50
Afternoon Tea
15:20
How to write clinical trial information for parent and children ?
Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy
16:00
Challenges in paediatric drug development, example with Down syndrome
Xavier Liogier, Clinical Scientist, Hoffmann La Roche Ltd
16:40
Chairman’s Closing Remarks and Close of Day Two

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