This in-house provides a unique opportunity to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillanc 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 In-house course will provide practical advice on how to comply with these requirements including how to handle adverse event reporting during medical device clinical studies.
Your next step is to call us now on +44 (0)20 7729 6677 or email us at firstname.lastname@example.org or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.
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
11.10 Coffee11.30 Application of the Reporting Rules
12.30 Lunch13.30 Legal Aspects of Manufacturers Reporting Obligations
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
09.30 Role of Notified Bodies in vigilance
11.00 Refreshments11.15 UK and vigilance: MHRA
12.00 Medical device regulation changes affecting PMS
Dr Ekkehard Stössleinn
13.00 Lunch14.00 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
Janette Benaddi is an Independent Consultant and previously Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a variety of services from preclinical to post market activities throughout the medical device product development cycle.
Janette has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. She has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
Janette is a registered nurse, who has obtained a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies. She also holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. She has published several articles relating to medical device regulation and clinical studies.