9th Annual Biomarkers Congress
Medical Device Clinical Congress / Clinical Evaluations and Investigations
Pullman Cologne
Ex Sofitel, Helenenstrasse 14,
KÖLN,, GERMANY 50667
http://www.informa-ls.com/mdcc
Medical Device Clinical Congress
Informa Life Sciences
http://www.informa-ls.com/mdcc
Pullman Cologne

Schedule of Presentations:

Tuesday, April 28, 2009
08:00:00 Registration and coffee
09:00:00 Chairman’s opening remarks
09:10:00 The evolution of regulatory requirements in the medtech industry Drago Cerchiari
09:30:00 Innovative approaches for strategic and successful clinical outsourcing David Ciavarella
10:05:00 Question and answer session
10:15:00 EXHIBITION HALL OPENS
10:15:00 Morning coffee and networking break/ exhibition viewing time
11:00:00 Managing clinical revisions to the Medical Device Directive: Regulator perspective Rob Higgins
11:35:00 What comes after the Medical Device Directive? Global harmonisation of the clinical evaluation of medical devices Sunita Prem Ahir
12:10:00 Aligning the regulatory and clinical strategy for product success Cheryl Hastings
12:45:00 Question and answer session
13:00:00 Lunch/ exhibition viewing time
14:00:00 Providing the right data to achieve reimbursement: The role of health economics Sharon Barnett-Myers
14:35:00 The clinical literature review: Pitfalls and guidance Anthony Wilkinson
15:10:00 Building a clinical case in the absence of a clinical trial Ian Purdy
15:45:00 Question and answer session
15:55:00 Afternoon coffee and networking break/ exhibition viewing time
16:25:00 The latest updates to ISO14155 and the Declaration of Helsinki 2008 Siep J Schepel
17:00:00 ISO 9001 Certification of the clinical department at Ethicon Endo-Surgery Europe Marc Immenroth, Klaus Luetke-Dartmann
17:35:00 Question and answer session
17:45:00 Chairman’s closing remarks and end of day one
Wednesday, April 29, 2009
08:00:00 Morning coffee
09:00:00 Chairman’s opening remarks
09:10:00 Medical registries: A tool for clinical evaluation for medical devices Max Aebi
09:45:00 Device registries and health systems research - Supplement or substitute to medical device studies Alexander Reiprich
10:20:00 Panel Discussion: The benefits and drawbacks of registries Siep J Schepel
10:30:00 Morning coffee and networking break/ exhibition viewing time
11:00:00 Application to ethics committees Peter H. Rehak
11:35:00 Ethical review of devices investigations in the UK David , Neal
12:10:00 Panel discussion: Gaining ethic committee approval
12:25:00 Spotlight session
13:00:00 Lunch
14:00:00 How are Notified Bodies managing the latest post-market clinical requirements? Christian Schübel
14:35:00 Managing the pressure of increased post-market trials Enrico Romano
15:10:00 Post-market clinical follow-up: from passive to active Klaas Van t' Klooster
15:45:00 Question and answer session
16:00:00 Chairman’s closing remarks and end of conference
4th Annual Pharma R&D Asia Congress
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