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New Medical Device Regulation Training Course

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.

12-13 Oct 2021

& 14-15 Oct 2021

Book now

Details

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

Introduction and background to the new regulation

  • Medical Device Coordination Groups
    Dr David Jefferys

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

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

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

IVDs and companion diagnostics Implications and timelines

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

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

Other essential considerations

  • Authorised representatives – increased responsibilities and requirements
  • Single registration numbers for all economic operators
  • New categories
  • Single-use devices – reprocessing?
  • Unique device identification
  • Safety and clinical performance summaries
  • Strategies to address the new requirements
    Dr David Jefferys

Presenters

Janette Benaddi (More...)

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.

Theresa Jeary (More...)

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 involved in the development of many commercially available medicinal and medical device products.

She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.

Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.

David Jefferys (More...)

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, 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 and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.

Book now

Book now

12-13 Oct 2021
Live webinar
12-13 Oct 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 31 Aug*
Enrol now
to attend
Live webinar
14-15 Oct 2021
Face-to-face, (venue not yet confirmed)
14-15 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 2 Sep*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Baxter
  • Bayer Medical Care BV
  • Bayer Pharma AG
  • Becton Dickinson
  • Bedfont Scientific Ltd
  • Biotop Medical
  • Bristows LLP
  • Cook Medical
  • Geistlich Pharma
  • Grünenthal GmbH
  • Halyard Health
  • Keystone Europe BV
  • Kimberly-Clark Europe Ltd
  • Latham & Watkins
  • LEO Pharma A/S
  • LYFSTONE AS
  • Medochemie ltd
  • Medtrade Products Ltd
  • Mundipharma International Services Ltd
  • Pioneer Regulatory Limited
  • Precipio Consulting
  • Presspart
  • Proctor & Gamble Technical Centres Ltd
  • Sanofi Aventis Deutschland GmbH
  • Saudi Food and Drug Authority
  • SGR Consulting Services Ltd
  • Sinclair Pharma
  • Smart Process Solutions Ltd.
  • sphere medical ltd
  • Torbay and South Devon NHS Foundation Trust

The speakers were very professional and knowledgeable. They delivered the content in an easy format and allowed plenty of time for questions and interaction from the attendees.
I particularly liked the section regarding the context of the regulation and background to its development which will help me when explaining this to my clients.

Stephen Rowe, Managing Director, SGR Consulting Services Ltd, Sep 19

Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.

Lucie Green, QA Manager, Vyaire Medical Products, Sep 19

A relaxed, open forum where you felt comfortable to ask any questions you needed through the presentations and the day. The speakers were all very clear, concise, factual and interactive.

Holly Widnall, Project Manager, Bedfont Scientific Ltd, Sep 19

Management Forum have become my go-to provider of life science training. They always find excellent speakers who present their subject matter in a very knowledgeable, complete and thoroughly enjoyable way. I have always found Management Forum courses to be excellent value for money and the New Medical Device Regulation course was no exception.

Stephen Matthews, Validation Consultant, Smart Process Solutions Ltd., Sep 19

Excellent training performed by very knowledgeable speakers.

Marie-Pierre Hontas, Senior Director Scientific & Clinical Affairs, Vexim SA – Stryker IVS, Mar 19

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

Marcel Steenhof, Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV, Sep 18

[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, Sep 18

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Feb 18

Excellent speakers

Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED), Feb 18

Very good.

Marie-Cécile Lerat, RA Manager MPS Europe, Becton Dickinson, Feb 18

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, Sep 17

Excellent, both content and speaker line up

Zinovia Chatzidimitriadou, Associate, Bristows LLP, Sep 17

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, Sep 17

Good interactions and good speakers

Katja Gauci, Device Quality Engineer, Mundipharma International Services Ltd, Feb 17

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

Dorte Reland, Director, PV Operations, LEO Pharma A/S, Feb 17