- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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7th Annual
Clinical Evaluations and Investigations for Medical Devices
25 - 26 April 2012
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7th Annual Clinical Evaluations and Investigations for Medical Devices
Real-life case studies on conducting efficient, cost-effective clinical studies, critical regulatory updates, and practical guidance on meeting international regulatory requirements
Clinical Evaluations and Investigations for Medical Devices provides crucial updates on the practical impacts of ISO 14155:2011 and expected changes following the Recast of the MDD 2007/47/EC. Take away real-life strategies for optimising clinical data analysis for approval and reimbursement.
Featuring for 2012, an International focus including Emerging Markets, US FDA requirements including
the 510k and feedback from GHTF Study Group 5.
Plus the largest ever number of real life case-studies and practical advice from large and small medical devices manufacturers.
2012 Clinical Evaluations and Investigations Medical Device conference highlights
- MHRA speaker: read more
- 3 Notified Body representatives: read more
- Real life case studies on running clinical trials: read more
- Practically meeting requirements for MEDDEV 2.7.1 – Rev. 3, Serious Adverse Events reporting, pre-market and post-market clinical studies: read more
- Drug Device Combination Products: read more
- Real life examples on challenges with equivalence claims, practically implementing PMCF and medical device registries: read more
- Brand new hot topics including usability and statistical analysis
Your expert speaker panel will include:
- Rob Higgins, Regulatory Section Head, MHRA
- Gert Bos, Head of Regulatory and Clinical Affairs, BSI
- Martin de Bruin, Global Commercial Director, Medical, DEKRA Certification
- John O’Dwyer, European Manager of Medical Devices, NSAI
- Juozas Galdikas, Director, The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
- Michael Hotze, Vice President, Head of Clinical Research, Institut Straumann AG
- Lynne Kelley, World Wide Vice President, Medical Affairs, Medical Surgical Systems, BD Medical - Medical Surgical Systems
- Wolfgang Werner, Vice President Quality Management, Regulatory Affairs and Operations,
Sequana Medical AG - Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Europe Regulatory Affairs
Department, Abbott Vascular International - Patrice Becker, Global Director, Clinical Affairs, Surgical Solutions Group, Covidien
- Daniel Shoukier, Global Director Regulatory Affairs, Biosensors Europe
- Ian Quirk, Worldwide Director of Clinical & Regulatory Affairs, Ranier Technology
- Stefan Menzl, Director International Regulatory Affairs, Abbott Medical Optics
- Greg LeBlanc, Manager, Regulatory Affairs and Quality Systems, Cook (Canada) Inc.
- Klaas Van 'T Klooster, International Clinical Research Manager, Depuy
- Philippe Scuiller, Regulatory Compliance Officer - MED, SANOFI
- Anne Williart, Clinical & Scientific Affairs, EMEA, Surgical, Bausch + Lomb
- Dottie Yourtz, Clinical Advisor, Boston Scientific
- Judith Hargreaves, Health Economics Manager, Ethicon
- Graham Lowe, Marketing and Operations Director, Deltex Medical Ltd.
- Roxanne Smarszcz, Manager, Medical Events, Post- Marketing Vigilance, Abbott Nutrition
- Ian Quirk, Worldwide Director of Clinical & Regulatory Affairs, Ranier Technology
- David Appleby, Director, Biostatistics and Clinical Research, Advanced Surgical Devices Division, Smith & Nephew
- Birte Petersen Jakobsen, Director, Medical Affairs, Global R&D, Coloplast A/S
- Kathleen Whanger, Quality Engineer - Risk Management Office, Boston Scientific International
- Toni Kennet Joergensen, Head of Corporate Regulatory Affairs, Institut Straumann AG
- Anthony Wilkinson, Medical Director, Cook Medical
- Laurie Clarke, Partner, King & Spalding LLP
- Lucio Fumi, CEO,Wyfold Medical Consultancy
- Paul Lafferty, Consultant, Medical Technology Consulting
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Sponsors
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Choose from 3 interactive sessions
Pre-Conference Workshop W: Tuesday 24 April 2012
Practical guide to conducting a successful Clinical Evaluation: Real life data
Evening Seminar Y: Wednesday 25 April 2012
Notified Bodies and Competent Authorities Panel: Harmonisation and successfully working with Medical Devices Manufacturers
Post-Conference Workshop X: Friday 27 April 2012
Practically implementing Risk Management and Risk Assessment in clinical studies
Reviews
"Great event with a lot of very helpful and useful information"
"This conference always brings me up to date on the most important topics in Medical Device trials"
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Sponsors
Dates and Venues
25 Apr 2012 - 26 Apr 2012
Radisson Blu Royal Hotel Dublin
Who will you meet? VP, Head of, Global Director, Director, Manager:
Regulatory Affairs
Clinical Research
Clinical Affairs
Medical Affairs
Medical Advisor
Project Management
Other Events That Will Interest You
7th Annual
Drug Device Combination Products
11 Sep 2012 - 12 Sep 2012
Holiday Inn Munich City Centre
