13 February 2010, 6:55 pm
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 [...]
3 November 2009, 10:05 pm
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”
31 August 2009, 10:29 pm
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 [...]
Filed under Events, Panels, Presentations, Workshops.
Tagged borderline, EC, europe, Medical device, medical device directive, member states, post market surveillance, Regulation, revisions
31 August 2009, 10:27 pm
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
Filed under Events, Presentations, Workshops.
Tagged Biotechnology and Pharmaceuticals, borderline, Business Services, clinical studies, Clinical trial, combination products, drug device, legal, Medical and Life Sciences, Medical device, medical device directive, product approval, Products Evaluation, revisions
31 August 2009, 10:13 pm
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 ”
Filed under Events, Presentations, Workshops.
Tagged authorised, authorised representative, authorized representative, Boston, Business Services, Consulting, European Union, frameworks, Healthcare, market, Medical and Life Sciences, Medical device, Regulation, representative