New Medical Device Regulation

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

4-5 Mar 2020

& 19-20 Oct 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 17 Jan

Book now

Course overview

During a period of great uncertainty and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare for these changes and operate successfully in Europe. The programme will provide in-depth coverage of the new regulations and how they will be implemented by member states and Notified Bodies. You will hear the latest thoughts on clinical development, safety monitoring, the role of authorised representatives, economic operators, and
the implications of Brexit.

There will be plenty of opportunities to discuss the implications of the changes with our expert faculty, and you will gain valuable guidance on successful implementation of the regulatory changes for your company products.

This is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

Who should attend

  • Regulatory affairs
  • Clinical studies
  • Vigilance
  • PMS
  • Quality systems
  • Technical support and business development.

Why you should attend

The seminar will provide key guidance and interpretation of the changes to the regulations and will be of value to all those who are involved with placing a medical device on the market, and anyone who requires an essential overview of the new MDR and its impact on the industry and working practices.

Programme Day One

Chair’s welcome and introduction
Dr David Jefferys

Introduction and background to the new regulation

  • Medical Device Coordination Groups
    Dr David Jefferys

Discussion session

Successful implementation of the MDR

  • Managing the urgency – time and resources are tight
  • What you really need to know – how to meet the key requirements
  • Clinical evidence – don’t underestimate its importance
  • The B word (Brexit)
    Peter Rose

Discussion session

Notified Bodies: how the changes will impact NBs and manufacturers – including the new rules for IVD conformity assessment

  • Accreditation and designation of NBs
  • How to register with NBs
  • Conformity assessment applications
    Theresa Jeary

Discussion session

Increased vigilance and post-market surveillance − how to comply

  • Post-market surveillance systems appropriate for your device and risk classification
  • Periodic safety update reports (PSURs)
  • Manufacturers’ response times to serious public health threats and deaths caused by devices
    Dr David Jefferys

Discussion session

Programme Day Two

IVDs and companion diagnostics

  • Implications and timelines
  • New IVD conformity assessment rules
    Theresa Jeary

Discussion session

Clinical investigations − what is required?

  • Greater protection for patients participating in clinical investigations
  • Products to have an acceptable benefit to risk ratio
  • Product safety and performance
  • Changes in data requirements
  • Restrictions by individual member states
    Janette Benaddi

Discussion session

Other essential considerations

  • Authorised representatives – increased responsibilities and requirements
  • Single registration numbers for all economic operators
  • New categories
  • Single-use devices – reprocessing?
    Dr David Jefferys

Discussion session

Other essential considerations (continued)

  • Unique device identification
  • Safety and clinical performance summaries
  • Strategies to address the new requirements
    Dr David Jefferys

Discussion session and key take-home messages

Presenters

Janette Benaddi

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.

David Jefferys

Dr 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.

Theresa Jeary

Theresa Jeary works for SFL as Head of Combination Products. She was previously Head of the Notified Body for Medical Devices at LRQA, where she was responsible for Devices Drug products and Class III Medical Conformity Assessment for a wide range of medical devices, including In-Vitro Fertilization Media and Solutions for Organ Preservation. 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.

Theresa 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, she 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, she 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. She holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.

Peter Rose

Peter Rose is the Managing Director for Maetrics in Europe. Having worked in the medical device industry for over 25 years, he has a wealth of experience and knowledge in quality systems and regulatory affairs. He is a lead auditor and a qualified microbiologist, and has a particular expertise in sterilization.

Maetrics provides consultancy, training, auditing services, business process outsourcing and project management of quality management systems and worldwide regulatory affairs including clinical evaluation reports for the medical device, pharmaceutical, in-vitro diagnostic and life science industries.

In addition to his Maetrics responsibilities, Peter is also a Director of Medilink East Midlands and sits on the MHRA Medical Device Industry Liaison Group, the ABHI Technical Policy Committee, the ABHI MDR Implementation Working Group and the ABHI Brexit Working Group. He has also been a guest lecturer at three universities (The University of Nottingham, Nottingham Trent University and The University of Sheffield), and is a Trustee of The Rock Church, West Bridgford.

Book now

4-5 Mar 2020
4-5 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 17 Jan*
Enrol now
19-20 Oct 2020
19-20 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Bayer Medical Care BV
  • Becton Dickinson
  • Bedfont Scientific Ltd
  • Besins Healthcare Pharma Services Ltd
  • Bristows LLP
  • Cook Medical
  • Croatian Agency for Medicinal Products and Medical Devices
  • Edwards Lifesciences
  • Ewopharma AG
  • Geistlich Pharma
  • Grünenthal GmbH
  • Halyard Health
  • Industrial Technology Systems Limited (ITS)
  • Johnson & Johnson Medical Ltd.
  • Keystone Europe BV
  • Kimberly-Clark Europe Ltd
  • Latham & Watkins
  • LYFSTONE AS
  • Magstim Company Ltd.
  • Medochemie ltd
  • Medtrade Products Ltd
  • Pioneer Regulatory Limited
  • Presspart
  • SGR Consulting Services Ltd
  • Sinclair Pharma
  • Torbay and South Devon NHS Foundation Trust
  • TQE Consulting SRL
  • Vexim SA – Stryker IVS
  • Vision RT Ltd
  • Vyaire Medical Products

Excellent training performed by very knowledgeable speakers.

Marie-Pierre Hontas, Senior Director Scientific & Clinical Affairs, Vexim SA – Stryker IVS

Good, complete coverage of the new regulations. Good anticipating on discussed items.

Marcel Steenhof, Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV

[The speakers were] all very knowledgeable. The whole course was very reassuring with the 'big monster' of the MDR being broken down so that it appears manageable and less scary. It was full of helpful advice both general and specific to my products.

Samantha Workman, ISO Manager, Torbay and South Devon NHS Foundation Trust

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Very good.

Marie-Cécile Lerat, RA Manager MPS Europe, Becton Dickinson

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

The speakers were very knowledgeable and lovely people and on the forefront of the devices industry. The presentations were very clear and interactive. The course was excellent and I would highly recommend to anyone wanted to learn about the new MDR.

Daniel Terzian, Project Assistant, NDA Regulatory Science Ltd

This was an excellent introduction to the Medical Device Regulation, focussing on the key changes and considerations to prepare for compliance with the new requirements. The experienced speakers provided much needed guidance and expertise.

Kate Cole, Regulatory Affairs Manager, Xiros Ltd

Excellent, both content and speaker line up

Zinovia Chatzidimitriadou, Associate, Bristows LLP

Great content

Andrew Whitton, Medtrade Products Ltd

Good interactions and good speakers

Katja Gauci, Device Quality Engineer, Mundipharma International Services Ltd

The speakers all did a great job, they were committed and inspiring.

Dorte Reland, Director, PV Operations, LEO Pharma A/S