Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.
The landscape of medical device and in-vitro diagnostic regulations in the EU and UK has undergone significant transformation in recent years. With the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) in May 2017, the regulatory framework has become more rigorous and complex. Staying abreast of these changes is crucial for professionals involved in regulatory affairs, quality assurance, and related fields to ensure compliance and maintain market access.
This course is essential for those seeking to stay fully updated on the latest regulatory developments.
Key topics to be addressed:
- Comprehensive insights into the rephrased implementations of MDR and IVDR
- Understand the new guidelines
- Learn about the role and output of the Medical Device Coordination Group (MDCG)
- Recent medical device regulatory developments in the UK, providing a comparative perspective on the evolving regulatory landscape
- Explore potential future developments and the evolving role of the European Medicines Agency (EMA) in the context of medical device regulations
This course offers a unique opportunity to hear from regulatory experts, discuss the implications of current and forthcoming regulations on working practices, and understand the potential impact on future regulatory strategies.
This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.
Benefits of attending
- Stay updated on MDR and IVDR implementations, new guidelines, and recent UK regulatory developments
- Explore the changes in the UK regulation as its system becomes independent and moves away from the EU rules
- Navigate the increasingly complex world of device and diagnostic regulations
- Gain insights into future changes to the regulations and how "digital medicine" may be regulated in the future
- Learn from leading regulatory experts and gain practical advice
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Speakers
Mr David Jefferys,
Senior Vice President ,
EisaiDr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
Ian Sealey,
VertexianIan Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in the private sector, local government, and the National Health Service.
In 2012 he joined the Civil Service as a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency and, in 2015, was appointed assistant secretary at the Department of Health, with responsibility for running its Departmental Board.
Since leaving the Civil Service in 2017 he has provided regulatory, quality, technical, and policy consultancy services to multinational and start-up medical device and in vitro diagnostic medical device manufacturers. His specialist interests include the risk management of electromedical devices, multi-legislative CE marking, and training delivery.
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
Sue Spencer,
New: Compliance Connextions | Prev: Qserve Group UK, LtdSue Spencer BSc (Hons) is Head IVD, Principal Consultant and UK Country Manager.
Sue leads Qserve’s IVD service, she has over 37 years’ experience in the Medical Device and IVD industries including extensive notified body experience.
Key areas of expertise include
- IVDD and IVDR regulations and transitions
- UKCA
- QMS implementation
- Internal, supplier and compliance audits
- Risk Management
- CDx
- Training
- Working with small start-up and multinationals
- Notified Body interaction
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for 3 notified bodies establishing two from scratch.
Sue has worked for Qserve for 4 years helping manufacturers transition to the IVD Regulation and leading a team specialising in both European and FDA submission and quality systems, with special interests in CDx.
Who Should Attend
This training course has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK, including medical device and in-vitro diagnostic professionals from the following areas:
- Regulatory affairs
- Clinical studies
- Vigilance
- Post-market surveillance
- Quality systems
- Technical support and business development
