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 into a coherent and
practical approach to PMS strategy and organisation.
Topics to be covered
• The place of PMS in the over-all compliance paradigm
• How the conference topics relate to this paradigm
• Organisational aspects of PMS in the global village
• Regulatory enforcement risk and how to minimise it through PMS
• How to optimise PMS to provide benefits beyond regulatory
compliance
• Future proofing of PMS
• Practical scenarios
What attendees will gain
Attendees will be able to reinforce what they have learned during the
conference lectures of the previous days by integrating them into a
coherent model. They will then gain insight into developing practical
strategies and organisational solutions for PMS using this model.

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 into a coherent and practical approach to PMS strategy and organisation.

Topics to be covered

• The place of PMS in the over-all compliance paradigm

• How the conference topics relate to this paradigm

• Organisational aspects of PMS in the global village

• Regulatory enforcement risk and how to minimise it through PMS

• How to optimise PMS to provide benefits beyond regulatory

compliance

• Future proofing of PMS

• Practical scenarios

What attendees will gain

Attendees will be able to reinforce what they have learned during the

conference lectures of the previous days by integrating them into a

coherent model. They will then gain insight into developing practical

strategies and organisational solutions for PMS using this model.

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