We can customise this course to meet the requirements of your organisation.
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
Janette Benaddi is an Independent Consultant and previously Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
She 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.
She is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies, she 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.
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.
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.
Roland Gerard, Independent Consultant and previously Vice President Regulatory and Quality Affairs International Division, St Jude Medical, where he was responsible for quality and regulatory compliance including vigilance within the International product division of St. Jude Medical. He was a member of the Global Harmonisation Task Force Steering Committee and a member of Study Group II on Vigilance and Post Marketing Surveillance representing EUCOMED. He was President of IAPM (International Association of Prosthesis Manufacturers) and past Chairman of the IAPM Technical and Legal Committee. He is currently chairman of the EUCOMED Regulatory Affair Committee (RAC).
Susana da Cruz Faria is a Product Technical Specialist / Scheme Manager of BSI Group, part of the Orthopaedic & Dental technical team. She joined BSI, after 12 years’ experience working for medical device manufacturers including Zimmer (Switzerland), Philips (Netherlands) and Ceramed (Portugal). In industry, she worked with joint replacement and spinal implants, as well coatings for orthopaedic implants and instruments. She has a Masters degree in Materials Engineering.