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
29-30 Jan 2019
Ensuring that a medical device remains safe and effective whilst on the market is an essential part of complying with the EU vigilance and post-market surveillance requirements outlined in the Directive 94/42/2 EC.
Competent authorities carry out market surveillance activities to certify that all devices comply with the latest regulations, ensuring that all devices in the market are safe for users. Post-market surveillance requires the manufacturer to monitor and review
their devices to identify any needs for corrective action. This activity is carried out in conjunction with authorised representatives, importers and distributors and is a key element of the manufacturer’s quality control system. It forms part of a PMS plan, which if carried out effectively can reduce the risk of adverse events. Manufacturers are then legally obliged as part of a vigilance process, to report any serious incidents or correction measures to the relevant competent authorities.
This seminar will give you practical advice on how to comply with the EU vigilance and post-market surveillance requirements. It will highlight manufacturers’ legal obligations and the risks associated with litigation, as well as providing essential guidance on how to report incidents in order to remain compliant. You will also gain practical advice and guidance on how to handle adverse event reporting during medical device clinical studies.
Attending these two days will offer you a unique opportunity to meet and network with Competent Authorities, Notified Bodies, lawyers, consultants and manufacturers to share good practice and experience.
This seminar will be of importance to all those involved in the medical device industry in the following roles and departments:
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
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette 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. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, 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. Janette has published several articles relating to medical device regulation and clinical studies.
Dr. Ekkehard Stösslein is the Deputy Head of the Medical Devices Department and Head of the Active Medical Devices and IVD Section at the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn/Germany. Prior to the constitution of BfArM in July 1994 he was with the former Bundesgesundheitsamt (Federal Health Department), organizing the practical implementation of the Active Implantable Medical Device Directive in Germany. He is a member of the Medical Devices Experts Group on Vigilance and was a member of the Study Group II of the Global Harmonisation Task Force.
Grant Castle is a Partner in the London office of Covington & Burling, practicing in food and drug regulatory law, with an emphasis on pharmaceutical and medical device regulation and associated data protection laws.
He has assisted clients with applications for the centralised approval of medicinal products, EC orphan drug designation, and with regulatory issues in the national approval process for medicines, including the EC mutual recognition procedure. He has participated in formal and informal good manufacturing practices (GMP), good clinical practices (GCP), advertising, borderline, drug safety and pharmacovigilance proceedings before the European Medicines Agency (EMEA), national authorities, courts and self-regulatory bodies. His litigation experience includes judicial review proceedings in the UK and EC courts, including the first challenge to a Community marketing authorisation for a medicinal product in the European Court of First Instance.
He received a BSc in Chemistry with first class honours from Imperial College of Science, Technology and Medicine in London in 1991 and a PhD in Organic Chemistry from Trinity College, University of Cambridge in 1994.
He has published extensively in the legal literature and has made several contributions to the technical literature in chemistry. He speaks and lectures frequently on pharmaceutical, medical device, data privacy and borderline products regulation at the Universities of Surrey and Wales, University of Cranfield, and business and professional groups in Europe and the U.S.
Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation 2013/473/EU dealing with Unannounced Audits. Joining BSI in August 2010 leading the BSI effort working with the Saudi Food & Drug Authority on the implementation of the SFDA Medical Device Interim Regulations.
Previously he held senior RAQA leadership positions at Spacelabs Healthcare, Teleflex Medical, Smiths Medical, Ohmeda (formerly The BOC Group healthcare business)
Medical Device experience is across a very broad range of devices including: anaesthesia systems, patient monitors, vapourisers, ventilators, breathing circuits, single use sterile disposables and devices for re-use, infant warmers, incubators, steralisers, autoclaves, operating tables, infusion pumps and associated disposables, urinary catheters, surgical instruments, diagnostic cardiology etc.
Paul is a member of the Association of British Healthcare Industries (ABHI) Technical Policy Group and is Convenor of the ABHI ISO TC 210 Mirror Group. Convenor of the BSI Committee, which monitors all of the work undertaken by ISO TC 210, and Convenor of the BSI Sub-committee dealing with Quality Systems. As UK Delegation Leader to ISO TC 210, Paul is also actively involved in the work of national, European and international standards’ committees, dealing with revisions to the ISO 9000 series, ISO 13485, ISO 14971, ISO 15223 and others. He is Deputy Chairman and Council Member of Barema (British Anaesthetic & Respiratory Manufacturers Association), also a Member of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Safety Committee.
Tony Sant is a Group Manager for MHRA’s Adverse Incident Centre and Biosciences and Implants specialist unit. He graduated in Physics at Imperial College, London and went on to obtain an MSc in Medical Physics and Medical Electronics at St Bartholomew’s Hospital. He joined one of MHRA’s precursors in 1985 from Medeci Medical Ltd. where he was employed as a medical electronics test engineer. At MHRA he has gained experience in: adverse incident investigation and incident systems development, quality systems auditing; medical device research and development, medical device evaluation project management, and general management of staff and other resources.
He has been instrumental in MHRA introducing and developing on-line reporting for users and manufacturers and was also closely involved in the development of SABRE MHRA’s Haemovigilance reporting system in 2005. He has been an active European representative of Study Group 2 (Adverse Events and Postmarket Surveillance) of the Global Harmonisation Task Force, where he led on guidance documents for electronic reporting of adverse incidents. He is an active member of the European Medical Device Experts Group on Vigilance and its sub-groups which recently revised the EU’s vigilance guidance and which currently are developing proposals for future comitology and recasting of EU medical device vigilance.