This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
1-5 Jul 2019
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process. It will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, workshops and case studies covering each process appliatble to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongide the presentations and workshops.
Bringing a Medical Device to the market place is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to a successful market placement comes from many different skilled individuals and organisations. Those contributing towards the placing of devices on the market should be aware of all the stages involved and be able to relate their responsibilities to the needs of other professionals, scientists, clinicians and regulatory and quality experts.
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process. It will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, workshops and case studies covering each process applicable to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongside the presentations and workshops.
This course has been designed primarily for those who wish to understand the processes involved in bringing a medical device to market. General medical devices as well as Active Implantable, In-Vitro Diagnostic and Drug Device products will be covered throughout the course. It will be of particular interest to those seeking to introduce new Medical Devices to the market. Previous delegates who have benefited from this course include regulatory, quality, clinical and marketing managers.
What is a Medical Device?
What Regulations Control the Manufacture and Marketing of Devices in the EU?
Competent Authorities (CA)
Notified Bodies (NB)
Workshop with Case Studies
Review of Day One
Risk Analysis and Risk Management
How Should a Risk Analysis be Conducted? – Risk Analysis Workshop
Biological Evaluation of Medical Devices
Technical Files and Design Dossiers
Quality Systems for Medical Devices
Labelling and Packaging of Devices
Review of Day Two
Regulations and Guidelines Applicable to Medical Device Studies
Gathering Clinical Data for CE Marking
The Clinical Investigation Process
Clinical Investigation / Evaluation Workshop
Documentation and Approvals for Conducting Clinical Studies
Review of Day Three
In-Vitro Diagnostic Products
Devices Incorporating Materials of Animal Origin
Making sense of reimbursement, regulation and market access
Working with Consultants, Contractors and Freelancers
Review of Day Four
Post Market Surveillance (PMS)
What constitutes Post Market Surveillance – Basic principles of PMS
Workshop with Case Studies
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.
Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).
He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.
Mark Charny has focused on evidence based medicine throughout his career. He qualified as a doctor and worked in general (family) practice before carrying out research into variations in clinical behaviour and their implications for guidelines and clinical audit. He obtained a PhD in identifying groups of patients in which health interventions are most cost-effective. He was a senior medical manager in the NHS for eight years, before spending two years at the UK Department of Health working on clinical effectiveness and clinical guidelines, including health needs assessment. He then became Director of the National Centre for Clinical Audit, which was funded by the UK government to promote clinical audit and quality improvement in the NHS.
In 1999, Mark founded Translucency. As Managing Director, he supports clients in the medical device, biotech, and pharmaceutical sectors in making the strongest possible business cases to payers in the UK and elsewhere in the EU. Translucency uses a blend of scientific, clinical, marketing and communications skills, market knowledge, and an extensive network of contacts in healthcare systems to advise and support clients who need to understand and manage the healthcare environment as it affects both new and existing products in a fast-moving environment.
He has published widely in the peer-reviewed medical literature and in other journals. He has spoken at many conferences to a wide variety of audiences, in the UK and abroad. He has refereed for peer-reviewed journals such as the British Medical Journal and Social Science in Medicine, as well as reviewing proposals for the NHS HTA programme.
Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.
Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.
She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.