Jun 5, 2019   SOURCE: PR NewsWire

New Medical Device Regulations Seminar: Managing the Transition (London, United Kingdom - September 24-25, 2019)

DUBLIN, June 5, 2019 /PRNewswire/ -- The "New Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.

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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.

The New Medical Device Regulation (MDR) brings about a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you embrace these changes and operate successfully in the new environment in Europe. It will cover in depth the new regulations and their implementation by the Member States and Notified Bodies. You will get to hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.

Why you should attend

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

Who Should Attend:

Personnel from the following departments:

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

Agenda:

Programme Day One

Chair's welcome and introduction
Dr David Jefferys

Introduction and background to the new regulation

    --  Medical Device Coordination GroupsDr 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 devicesDr 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 statesJanette 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 requirementsDr David Jefferys

Discussion session and key take-home messages

Speakers:

David Jefferys
Senior Vice President
Eisai

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.

Janette Benaddi
Director of Clinical & Consulting Europe
NAMSA

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 ahs also provided training to Notified bodies in this subject.

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.

Peter Rose
Managing Director
Maetrics

Peter Rose is the Managing Director for Maetrics in Europe. Having worked in the medical device industry for over 25 years, Mr. Rose 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.

For more information about this conference visit https://www.researchandmarkets.com/r/3unu77

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Research and Markets
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press@researchandmarkets.com

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