A large number of medicines used in paediactric care have not been tested on children and are therefore used off lable or unlicensed. This absence of suitable authorised medicinal products to treat conditions in children is an issue that has been of concern for some time, and one that is increasingly coming to the fore.
Returning for its ninth year as an industry leading event, weare proud to present the 9th annual
Paediatric Clinical Trials Conference, 25th - 26th March 2015, 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.
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 effectively submit a PIP that meets FDA and EMA regulations and improve skills and understanding of the responsibilities of conducting clinical research in the paediatric population. In addition, consideration of new approaches for clinical trial design to keep costs down whilst navigating the complexities of paediatric research, makes this a must-attend meeting for all individuals based in the world of paediatric trials and care.
Key topics include:
- Guidelines on the Paediactric Investigation Plan (PIP) – strategies to overcome any challenges
- Formulating meaningful statistics with a limited patient population
- Site selection and feasibility- identifying appropriate clinical trial sites
- Optimizing patient retention strategies for successful trial development
Benefits of Attending
This two day networking event will invite in depth discussion of the key drivers impacting Paediatric Clinical Trials. Join us and discover what is going in this burgeoning market to:
- Hear about strategies to covercome PIP challenges
- Meet with industry pioneers to discuss how they see the sector advancing
- Network with major players and see what your competitors are working on
- Determine efficient and effective measures to expand thinking and new approaches to clinical trial
Plus An Interactive Pre-Conference Workshop | 24th March 2015
Paediatric Drug Development – Vision, Challenges, StrategyWorkshop Leader: Klaus Rose, CEO, klausrose Consulting
10.30am - 4.45pm
‘Some great and interesting presentations’
Allergan
Speakers
- Cristina De Min, Chief Medical Officer, NovImmune SA
- Daniel Bar-Shalom, Associate Professor, University of Copenhagen
- David McIntosh, Head, Global Scientific Affairs, Novartis Vaccines
- Deborah Lee, Senior Medical Director, Clinical Affairs, Lundbeck, USA
- Diana A. van Riet - Nales, Senior pharmaceutical assessor, Chemical Pharmaceutical Assessments (CFB), Member EMA Quality Working Party, Medicines Evaluation Board in the Netherlands (MEB)
- Dr Elin Haf Davies, Director & Founder, Empowering Children | Enabling Research
- Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy
- Klaus Rose, CEO, klausrose Consulting
- Mette Due Theilade Thomsen, Principal Scientist, Paediatric Investigation Plan (PIP), Regulatory Affairs, Novo Nordisk A/S, Denmark
- Neil Parrott, Modelling & Simulation Scientist, Pharmaceutical Sciences, Roche Innovation Center Basel, Roche Pharmaceutical Research and Early Development
- Philippe Auby, Vice President of Global Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck, France
- Professor Koenraad Norga, Head of Clinic Paediatric Oncology, Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric Commitee (PDCO)
- Roy Turner, Formulation Project Leader, Paediatric & Geriatric Network Leader, Technical Research & Development, Novartis Pharmaceuticals
- Sabah Attar, Divisional Head of Portfolio Operations, NIHR Clinical Research Network: Children
- Solange Rohou, Director Regulatory Affairs/Policy Europe, AstraZeneca
- Susan Cole, Senior Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, MHRA
- Terry Ernest, Formulation Team Manager, Global Formulation, Product Development, GlaxoSmithKline R&D
Please fill in your name and email to receive the conference agenda of this event.
The agenda is available as PDF under downloads at the right side of the page.
Venue
The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.
Who Should Attend
Senior Vice Presidents, Vice Presidents, Directors, Heads of Department with responsibility in the following departments:
- Paediatrics
- Research and development
- Drug Development
- Clinical research
- Formulation development
- Regulatory affairs
- Medical writing
- Analytical scientist
- Medical affairs
- clinical pharmacology
- clinical research
- Parents and patient advocacy organizers
Venue
Holiday Inn Regents ParkCarburton Street
London
W1W 5EE England
