Archive of posts filed under the Workshops category.

Medical Device Post Market Surveillance & Vigilance

16 – 18 February 2010, Berlin. Germany
Conference programme
Workshop on “Practical Issues in Developing a Strategy and Organisation for PMS” on 18 September

PMS, in particular its vigilance and clinical evaluation components, is
crucial in ensuring the survival of the manufacturer’s medical devices in
the increasingly regulated market place. This workshop will integrate
elements from the preceding conference days [...]

Drug Device Combination Products

17-19 November 2009 in Prague, Czech Republic
Drug Device Combination Products
Presentation on “Drug/device borderline – latest developments”
Organised and led a workshop on “Post Market Surveillance for Drug-Device Combination Products”

Managing the Revisions to the Medical Device Directive

27-29 January 2009 in Brussels, Belgium

Managing the Revisions to the Medical Device Directive

Chaired the conference.
Organised and led a workshop on “How to conduct Post Market Surveillance correctly”

Presentations on “Interface of the Medical Devices Directives with other
legislation in particular borderline issues” and “Basic legal and general aspects of Post-Market Surveillance”
Participated [...]

Drug Device Combination Products

27 – 29 October 2008, in Barcelona, Spain

Drug Device Combination Products

Organised and led a workshop on “Developing effective clinical studies for combination products”
Presentation on “Combination products: legal considerations in borderline determination and clinical implications” and “How have the revisions to the Medical Device Directive impacted on combination product approval?”
Event website

RAPS Annual Conference 2008

September 14 – 17, 2008 in Boston, USA
RAPS Annual Conference

Preconference Workshop on the Role of the Authorised Representative in the EU Medical Device Market
Presentation on “Overview of the EU Medical Device Regulatory Framework and the Role of EAAR and Authorized Representatives in It ”