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The total R&D investment of bringing a new product to market has been estimated to be close to £400 million. Delays are expensive and even a few days could potentially cost millions of pounds. Each country has its own guidelines which can be highly regulated, so it is crucial to understand the complexities of conducting clinical trials in various parts of the EU.
SMi’s 6th annual conference on Conducting Clinical Trials in Europe is a must attend event that will cover regulatory developments in the European environment whilst paying close attention to the recent inclusion of paediatric studies for all clinical trials. It will also cover various aspects of patient recruitment and retention and will analyse key logistical challenges. Recognised experts from within the EU community will give best practice advice on which components are needed for a successful trial, including key requirements for good clinical practice, outsourcing and adequate inspections to ensure your company maximises its patient involvement and clinical trial supply.
Critical challenges that will be addressed: - DISCOVER the importance of paediatric studies and what measures you need to take to ensure your trials are successful
- EXAMINE the challenges and opportunities with clinical trial logistics operations and the rest of the supply chain
- ANALYSE suitable patient recruitment and retaining strategies, and understand patient motivation
- ASSESS the pros and cons of conducting multiregional trials and learn the value they can bring
- DISCUSS the regulatory requirements to ensure inspections run smoothly and how to effectively setup clinical trials in different countries
Exclusive presentations from industry experts including: - Alex Kudrin, Clinical Assessor, Biological Licensing, MHRA
- David McIntosh, Medical Director, Infectious Diseases (Europe, the Middle East and Africa), Wyeth Europa and Honorary Clinical Senior Lecturer, Imperial College
- Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe
- Christian Clauss, Director, NPD RA Bioscience Global, Baxter Bioscience
- John Bolodeoku, Vice President, Medical Affairs & Health Economics, Astellas Pharma Europe Ltd.
- Ajay Duggal, Senior Medical Director, Genzyme Europe Research
- Hermann Kulmann, Head, Clinical Statistics Europe 1, Asia Pacific, and Japan, Bayer Schering Pharma AG
- Henriette Fugman Bech, Senior Clinical Supply Co-ordinator, Novo Nordisk
- Jonathan Blamey, Vice President, Product Development & Marketing, DHL Exel Supply Chain
- Ian Thomson, Team Leader, Global Quality Auditing and Compliance, Eli Lilly & Company
- Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline
- Johann Proeve, Global Head Data Management, Bayer Schering Pharma
- Luke Eley, European Business Development Director, Hays Pharma
- Renate Aloulou-Gilbert, Training Manager, GPRD Clinical Training, International Clinical Field Operations, Abbott GmbH & Co KG
- Chris Tierney, Business Development Manager, EMEA Business Development, DHL Exel Supply Chain
- Heike Roeder, Director, Global Head of CTS Planning, UCB Group
You will benefit from attending this event if you are: A Vice President, Director or Head of: - Clinical Operations
- Clinical Trials Logistics
- Clinical/Investigational Supplies
- Clinical Trials Material Management Medical
- Clinical Quality Assurance/Quality Control
- Clinical Research / Planning
| - Outsourcing & Procurement Managers
- Regulatory Affairs
- Good Clinical Practise
- Patient recruitment
- Adaptive design
- Business Development
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Last years’ delegates included: - Astellas Pharma EU
- AstraZeneca
- Galderma R & D
- Merz Pharmaceuticals GmBH
| - Genzyme Europe
- Pfizer spol. s r.o.
- Takeda Global Research & Development Center
- Zeincro Hellas S.A
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For Speaking opportunities please contact Mamta Patel at mpatel@smi-online.co.uk
For Sponsorship opportunities please contact Alia Malick at amalick@smi-online.co.uk * Alex Kudrin will be speaking in a personal capacity.
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