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.
Benefits of attending this five day course:
- Understand the procedures for taking a medical device to the market place
- Learn what regulations control the manufacture and marketing of devices in the EU
- Be prepared for the changes to the requirements and the impact of the MDR
- Gain an insight into different aspects of the process for obtaining the CE Mark for a device
- Discover a holistic approach to device development and marketing
- Participate in workshops and learn from other people’s experiences
- Understand how other professionals affect the process of bringing a device to market
- Network with participants from organisations similar to your own
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
09.00 Registration and Refreshments
09.30 Welcome and Introductions
- Overview and objectives of the course
10.00 What is a Medical Device?
- Definitions and examples
- Device innovation
- How is a device developed from concept?
- The design process
11.30 What Regulations Control the Manufacture and Marketing of Devices in the EU?
- The Medical Device Directives explained (AIMDD, MDD and IVDD)
- Interpreting the Directives and implementation
- Device classification
13.45 How Does a Device Obtain a CE Mark?
- What does the CE Mark mean?
- Overview of the CE Mark process for a device
- Conformity Assessment routes
14.30 Competent Authorities (CA)
- What is a Competent Authority?
- The role of a Competent Authority
- The responsibilities of a Competent Authority
- Relationships with manufacturers
15.30 Notified Bodies (NB)
- What is a Notified Body?
- The role of a Notified Body
- The responsibilities of a Notified Body
- Relationships with manufacturers
16.00 Workshop with Case Studies
Janette Benaddi & John Webster
17.15 End of Day 1
19.30 Conference dinner at a local restaurant
- An opportunity for participants and speakers to relax and enjoy a drink and a meal together on the first evening of the Summer School.
09.00 Review of Day One
09.15 Risk Analysis and Risk Management
- Review of ISO EN 14971:2012,‘Medical Devices Application of Risk Management to Medical Devices’
- What procedures must a manufacturer follow?
10.30 How Should a Risk Analysis be Conducted?
- Risk Analysis Workshop
11.30 Biological Evaluation of Medical Devices
- ISO 10993 and the biological safety assessment process
- Where product safety assessment fits in New Product Development
13.30 Technical Files and Design Dossiers
- What are these documents?
- What should they contain and how should they be presented?
14.30 Quality Systems for Medical Devices
- What is a Quality System?
- What do manufacturers need to do to implement a Quality System?
- What are the regulations and guidelines for Quality Systems?
15.45 Labelling and Packaging of Devices
- What information needs to be provided and how should it be set out?
- What regulations and guidelines should be followed?
17.00 End of Day 2
- For information, the Victoria and Albert Museum is situated opposite the hotel and is open until 17.45. Harrods and Harvey Nichols Department Stores are open until 20.00 Mon-Fri and are a 10 minute walk away. A gym and swimming pool are available to residents next door to the hotel for a nominal fee.
09.00 Review of Day Two
09.15 Regulations and Guidelines Applicable to Medical Device Studies
- Review of ISO 14155 and other available guidelines
10.30 Gathering Clinical Data for CE Marking
- How to gather data, the Clinical Evaluation process
11.15 The Clinical Investigation Process
- The practicalities associated with Clinical Investigations
12.00 Clinical Evaluations from a Notified Body Perspective
12.45 Feedback and Discussion
14.00 Clinical Investigation/Evaluation Workshop
15.15 Documentation and Approvals for Conducting Clinical Studies
- Documents required
- Ethics Committees
- Competent Authorities
16.15 Workshop Session
17.00 End of Day 3
Late night shopping is available in Knightsbridge which is 5 minutes walk from the hotel. There are a number of local restaurants in the surrounding area.
09.00 Review of Day Three
11.15 Working with Consultants, Contractors and Freelancers
- Advantages and disadvantages of outsourcing
- Ideal profile of an outsourcing partner
- The key to a successful relationship
10.30 In-Vitro Diagnostic Products
- Exploration of the IVD Directive and its implementation
- New regulations - the review of the IVD Directives
- Impact of the user on compliance and Risk Analysis
10.30 Making sense of the European Reimbursement Environment
- Making sense of reimbursement, regulation and market access
- Understanding different approaches adopted to the reimbursement of medical devices
- Implications for manufacturers of medical devices
13.45 Drug/Device Products
- Regulations for demarcation of medicinal products and devices
- Exploration of borderline issues
- Quality considerations
15.15 Devices Incorporating Materials of Animal Origin
- What’s the risk?
- Specific standards on animal materials
- Conformity assessment for devices containing animal-derived materials
16.30 End of Day 4
EVENING ENTERTAINMENT - THEATRE TRIP
Drinks and sandwiches will be served at 18.00 hours and a buffet supper will be served on our return to the hotel. Past musicals we have been to include; Chicago, Mamma Mia, My Fair Lady, Mary Poppins, We Will Rock You and Top Hat.
09.00 Review of Day Four
09.15 Post Market Surveillance (PMS)
- What constitutes Post Market Surveillance - Basic principles of PMS
- The regulatory requirements for PMS
- The increasing importance of PMS
- A review of available guidelines for PMS
10.00 EC Medical Device Vigilance
- Basic principles
- Reporting arrangements
- Role of manufacturer, Competent Authority and Notified Body
- Review of the available guidelines for Device Vigilance
11.10 Refreshments and Check-out
11.40 Workshop with Case Studies
Janette Benaddi & Tony Sant
12.30 Concluding Remarks - Janette Benaddi
13.00 Lunch and End of Course
A buffet lunch will be served in the conference room. Sandwiches will be available as a packed lunch for those who need to leave promptly.
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.
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.
Adrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was previously Head of Notified Body for the UK Notified Body SGS. Prior to that he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Devices Directive.
In this role he combines his experience from new product development with EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.
Adrian has 25 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the Notified Body LRQA. Prior to that he worked in the medical device industry, latterly as Global Product Safety Manager at Smith and Nephew. Here he created a highly effective team delivering product safety and risk management to Smith and Nephew’s global wound management portfolio. His team was responsible for providing toxicological and risk management strategies to expedite product launches, commercialisation, and post market activities, including Far Eastern markets (Japan and Korea).
He joined Smith & Nephew directly from The School of Pharmacy (University of London) following postgraduate research in retinoid-induced skeletal toxicity and an honours degree in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute.
Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and has been an active participant in NB-MED and NBRG.
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.
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.
Nick Baker joined Lloyds Register Quality Assurance Limited in 2001 as IVD Technical Manager and is responsible for ensuring the technical integrity of the certification services provided by LRQA under the IVD and PPE directives. This involves ensuring that there are appropriate resources to meet client needs, assessing the impact of any regulatory changes and informing clients of the conformity assessment requirements to achieve CE certification for their products.
He started work in the pathology laboratories at the National Hospital for Nervous Diseases and then the Royal Free Hospital. He then moved into the diagnostics industry as a production scientist. During this time he undertook an MSc in Medical Biochemistry at Brunel University.
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.
The Rembrandt Hotel
11 Thurloe Place
Opposite V&A Museum.
Nearest underground station: South Kensington.