This conference provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillance including Vigilance
While the pre-market approval process has been delegated by most of the Competent Authorities to the private sector, Competent Authorities have kept the responsibility for the surveillance of their market. Because of this situation there is transfer of resource and energy to the monitoring of markets including the vigilance system within each Member State. The evaluation of incidents notified by manufacturers and users represents a key source of information for authorities, combined with sophisticated exchange of information between EU Member States, and with other countries like USA, Japan, Canada or Australia, provides a unique insight into the performance of devices in the post production phase.
Full compliance with the vigilance requirements laid down in Article 10 of Directive 93/42/EC is justified by the manufacturers’ legal obligations, risks associated to litigation and increasing scrutiny of Member States, but mainly by the ultimate objective of providing safe devices to patients. It is essential that manufacturers ensure compliance with these requirements.
This conference will provide practical advice on how to comply with these requirements including how to handle adverse event reporting during medical device clinical studies.
This conference provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillance including Vigilance.
This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community.
09.30 Chairman’s Welcome and Introduction Roland Gérard
09.40 Introduction to Post Marketing Surveillance Tony Sant
10.20 In Depth Review of the EU Vigilance Process Roland Gérard
11.30 Application of the Reporting Rules
13.30 Legal Aspects of Manufacturers Reporting Obligations
14.30 Legal Aspects of FSCA
16.00 Field Safety Corrective Actions (FSCA): Expectations from Authorities
Dr Ekkehard Stösslein
16.30 Handling of Field Safety Corrective Actions (FSCA) – Industry Perspective
17.30 End of Day One
09.00 Post Marketing Surveillance: an integral part of the QA system
09.30 Role of Notified Bodies in vigilance
10.20 Germany and vigilance:BfArM
11.15 UK and vigilance: MHRA
12.00 Medical device regulation changes affecting PMS
Dr Ekkehard Stössleinn
14.00 Revision of vigilance guidelines:
15.00 PMS and adverse event reporting during medical device studies
16.00 Discussion and closing remarks
16.15 Close of conference
Adverse Event Management During Medical Device Clinical Studies on 28 January 2016
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.