An Essential Overview of the Medical Device Industry

This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.

21 May 2019

GBP 699
EUR 979
USD 1,090

Book now

Course overview

The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery.to enhance the performance of medicine and as a part of life cycle management. Medical Devices are also being employed to monitor compliance in clinical trials and post marketing as well as being being used to monitor patients in trials. This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.

Benefits of Attending this Seminar

  • Gain an Overview of the Medical Device Industry
  • Learn About Medical Device CE Marking
  • Gain an overview of medical device and IVD regulation and the new legislative proposals
  • Understand Clinical Trial Controls and Device Vigilance
  • Discuss device / drug combination products

Book both

This meeting runs back-to-back with An Essential Overview of the Pharmaceutical and Biotech Industries and there is a £100/€140 discount off when booked with together with An Essential Overview of the Pharmaceutial and Biotech Industries

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Why you should attend

The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery.to enhance the performance of medicine and as a part of life cycle management. Medical Devices are also being employed to monitor compliance in clinical trials and post marketing as well as being used to monitor patients in trials. This one day workshop aims to give all the key information necessary to understand the regulation of Medical Devices and Diagnostics and to appreciate the key differences from Pharmaceutical regulation.

Who should attend

The course has been specifically designed to meet the needs of those working in Pharmaceuticals and in allied business functions who need to understand this sector. The course will be particularly relevant for regulatory staff, those in clinical research, medical affairs and business development.

Programme

  • What is a medical device?
  • What are the differences in approach from pharmaceuticals
  • How is the device market developing
  • An overview of the medical device and in-vitro diagnostics legislation, including the implementation of the 2017 Medical Device and IVD Regulations
  • The role of the Competent Authority and Authorised Representative
  • Brexit an update – what might happen
  • What is a Notified Body and how are medical devices and IVDs evaluated
  • What are the data requirements?
  • How to work with a Notified Body
  • Clinical trial controls for devices
  • Device vigilance versus pharmacovigilance
  • Device/drug combination products and companion diagnostics
  • Building a global approval strategy on an EU CE Mark Approval
  • The key interface with digital technology

Presenters

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 is Head of the Notified Body for Medical Devices at LRQA, where she is 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. She 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.

Book now

21 May 2019
21 May 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • A.A. Thornton & Co
  • Astellas Pharma Europe B.V.
  • Bard Pharmaceuticals Ltd
  • Bayer plc
  • Bells Healthcare
  • Bespak Europe Ltd
  • Boehringer Ingelheim Vetmedica GmbH
  • Convergence Pharmaceuticals
  • F. Hoffmann-La Roche Ltd
  • IPSEN Pharma
  • Irish Patents Office
  • Meda Pharmaceuticals Limited
  • Medicines & Healthcare Regulatory Agency
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MPCHC Ltd
  • Napp Pharmaceuticals Ltd
  • Norgine Ltd
  • Novartis Ireland Ltd
  • Panacea Pharma Projects Ltd
  • Philips
  • Quanticate
  • Redline Pharmacovigilance Ltd
  • RWS Translations Ltd
  • Segulah Consulting Limited
  • Smith & Nephew plc
  • SPD Development Company Limited
  • Teva Pharmaceuticals Ltd
  • TEVA UK
  • UCB A/S
  • Université Paris Sud

Enjoyed the course, felt the topics were covered in enough detail given the subject matter. Informal atmosphere with a small number of delegates meant opportunity for questions which were welcomed. Both speakers were clearly passionate about their subject and this was evident during their presentations.

Gillian Hakewill, Regulatory Affairs Officer, SPD Development Company Limited

Very nice overview

Camiel Kulker, Senior Regulatory Affairs Manager , Astellas Pharma Europe B.V.

Both speakers were excellent and obviously knew their subject in great depth

Peter Davies, Quality Engineer, Bespak Europe Ltd

The course was delivered by highly educated industry experts who shared their extensive knowledge in a clear and entertaining manner. The delegate numbers were small which allowed for a very personal service. I will be recommending Management Forum courses to my colleagues.

Stephanie Kirby, Senior Regulatory Affairs Officer, Bells Healthcare

Just brilliant – speakers were so very knowledgeable

Valentina Curran, Senior Medical Affairs Executive, Norgine Ltd.

The course material is very good. The speakers were excellent and the manner in which they presented.

Jovana Jevtic, , Bard Pharmaceuticals Ltd

The course is great for people having no idea about the medical device industry. Makes you understand the key differences between pharmaceuticals and medical devices in terms of regulations and vigilance.

Francois Rugiero, , Convergence Pharmaceuticals

Well presented - clear and concise.

Paul Glennie, Project Manager, Napp Pharmaceuticals Ltd

Excellent course, pitched at the right level for people new to this area of work

Dolores Cassidy, Patent Examiner, Irish Patents Office

Good content

Anna Somuyiwa, Regulatory Affairs Consultant , Segulah Consulting Limited

Excellent course, pitched at the right level for people new to this area of work.

Dolores Cassidy, Patent Examiner, Irish Patents Office

Did what it said on the tin - personally would like to see more of a marketing focus than regulatory but the day delivered what it promised.

Richard Addy, Senior Director, Customer Success, Veeva

I understand that the course has to be a "one size fits all", which inevitably means that not all items covered will be relevant to all participants. However, it was good that the presenters took it in turn to speak and on the whole the course was well-structured and presented.

Julie Norris, Product Technical Complaints Officer, Bayer Public Limited Company