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Early Bird

An Essential Overview of the Medical Device Industry Training Course (ONLINE EVENT: July 8-9, 2024)

2 Days: July 8th 13:00 - July 9th 17:00 GMT+1
  • Conference
  • Management Forum
  • ID: 5893064
OFF until Jun 03rd 2024

The concept of ‘Life Sciences’ is with us as we see the convergence of pharmaceuticals, medical devices and diagnostics. We are seeing the evolution of combination products, companion diagnostics, novel delivery systems, digital medicines and the introduction of artificial intelligence-enabled products. 

This training course has been designed to provide you with an up-to-date overview of the medical device industry, and will be beneficial for anyone working in the pharmaceutical industry who requires an understanding of the medical device sector and the interface between the two. It will also be beneficial for those new to medical devices and those who require a refresher on recent changes in this fast moving sector. 

How are the regulations changing?

What are the new rules for devices and diagnostics in the UK post-Brexit?

These key questions and many others will be answered by our experts in this focused programme and will provide an excellent opportunity to discuss the complexities involved. 

Benefits of Attending:

  • Gain a better understanding of the medical device industry
  • Be aware of the changing regulatory landscape
  • Lean about the evolving interfaces between pharmaceuticals and medical devices
  • Gain insights into the regulation of digital medicines
  • Learn the new rules for devices and diagnostics in the UK post-Brexit
  • Benefit from an opportunity for your questions to be answered 

Agenda

The Convergence of Pharmaceuticals, Medical Devices and Diagnostics

  • What is a medical device and an In-Vtiro Diagnostic (IVD)?  
  • How is the device market developing? 
  • The emergence of the ‘Life Science’ industry, digital medicine and AI-enabled products 
  • The challenges for regulation 

An Overview of the MDR and IVD Directives and the Regulations

  • Update on the MDR implementation
  • Update on the IVDR implementation

What are the Key Differences in Approach from Pharmaceuticals?

  • Who are the key players? 
  • The role of the Competent Authority and Authorised Representative

Brexit Update

  • Impact on the medical device industry

Notified Bodies

  • What is a Notified Body? 
  • How to work with a Notified Body 

How are Medical Devices and IVDs Evaluated?

  • What are the data requirements? 

Review and Summary of Role of Notified Bodies

  • How to work with Notified Bodies
  • Role in changes to the device post-approval
  • Future developments for Notified Bodies 

Clinical Trial Requirements for Medical Devices

  • The control of trials for MDs and IVDs 
  • Phased introduction of the new EU system 
  • Controls for combination products 
  • Device and IVD Scientific Advice 

Medical Devices Vigilance versus Pharmacovigilance

  • The Regulatory System
  • Adverse event report - Vigilance
  • Post marketing surveillance
  • User reporting systems
  • Human factors requirements

Device/Drug Combination Products and Companion Diagnostics

  • The Operation of Article 117 and Latest Guidance

Post Brexit MD and IVD controls in the UK

Future Changes, Influence of the Pharmaceutical Package, Role of the EMA, Regulation of Digital Devices and Global Harmonisation

Speakers

  • David Jefferys
  • Mr 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.

  • Theresa Jeary
  • 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.

Who Should Attend

This course is a must for:

  • Personnel from the pharmaceutical industry who want to learn more about the devices and diagnostic sectors
  • All those who want to understand the interface between devices and pharmaceuticals
  • Those who require a refresher on recent changes in the medical device sector