9th Annual Biomarkers Congress
Managing the Revisions to the Medical Device Directive
Hotel Bloom
Brussels
, Belgium
http://www.informa-ls.com/revisions
Managing the Revisions to the Medical Device Directive
http://www.informa-ls.com/revisions
Hotel Bloom
Brussels
Belgium

Schedule of Presentations:

Tuesday, January 27, 2009
08:15:00 Registration and coffee
08:50:00 Chairman’s welcome and opening remarks
09:00:00 An overview of the revision of the MDD Sharon Frank
09:30:00 How the amendments to the MDD will affect your notified body audit Chris Jepson
10:00:00 Question and answer session
10:15:00 Networking break
10:45:00 Evaluating conformity assessment changes Norman Richardson
11:15:00 Reclassification of products: Challenges and practical guidance Rebecca Sheridan
11:45:00 Reuse and reprocessing of single use devices Peter Schroer
12:15:00 Question and answer session
12:25:00 Lunch
13:30:00 A background to the revisions of clinical requirements: Competent Authority guidance Jos Kraus
14:00:00 Implementing new clinical requirements: Industry implementation Janette Benaddi
14:30:00 Question and answer session
14:45:00 Networking break
15:15:00 Progress update of post-market surveillance requirements Jacques Thielen
15:45:00 Meeting vigilance reporting requirements Laura Locati
16:15:00 Effect of the revised directive on medical device labelling Roger Gray
16:45:00 Question and answer session
17:00:00 Chairman’s closing remarks and end of Day One
Wednesday, January 28, 2009
08:30:00 Morning coffee
08:50:00 Chairman’s welcome and opening remarks
09:00:00 The impact of environmental regulation Marc Kirstetter
09:30:00 The regulation of software in the EU Trevor Lewis
10:00:00 Question and answer session
10:15:00 Networking break
10:45:00 Implementing revisions affecting your combination product Gert Bos
11:15:00 The regulation of Advanced Therapy Medical Products Alison Wilson
12:15:00 Interface of the Medical Devices Directives with other legislation in particular borderline issues Mika Reinikainen
12:45:00 Question and answer session
13:00:00 Lunch
14:00:00 A practical guide to implementing the changes Sandy Geddes
14:30:00 The role and performance of notified bodies Peter N Ruys
15:00:00 Question and answer session
15:15:00 Networking break
15:45:00 The implementation of medical device directives in an EU candidate country Sinisa Tomic
16:15:00 The implementation of the revisions of the Directive in existing Member States Mike Kreuzer
16:45:00 The recast of the Medical Device Directive Roland Gerard,
17:15:00 Question and answer session
17:30:00 Close of conference
4th Annual Pharma R&D Asia Congress
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