• Home
  • Courses
  • Advanced Regulatory Affairs for Medical Devices

Advanced Regulatory Affairs for Medical Devices

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

26-27 Mar 2020

& 8-9 Oct 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

The regulatory environment for medical devices is in a transitional period. With the increased focus on patient safety, the MDR has introduced many changes to the requirements and processes involved.

Designed for professionals with a working knowledge of medical device regulatory affairs, this course will provide essential guidance on how to successfully transfer products from the current regulatory system under the Medical Device Directive (MDD) to the new MDR. Regulatory strategy and life cycle management will be a key focus of the programme with comprehensive sessions
on regulatory pathways, technical documentation, clinical evaluations and investigations. There will also be a review of the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies.

Delegates will cement the knowledge gained through case studies and practical workshops and there will be ample opportunity to discuss the complexities involved with two medical device experts, both of whom have huge knowledge and experience in this field.

This event would be an excellent follow-on course from our three-day programme An Introduction to the Medical Device Regulation.

Who should attend?

This course will provide experienced medical device professionals with the practical regulatory knowledge to apply life cycle management in an MDR environment, particularly those who play a key role in transitioning their products to the MDR.

  • Medical device regulatory affairs professionals
  • Vigilance and PMS managers
  • Clinical evaluation/investigation specialists
  • Project managers

Programme day one

Introduction and pre-market requirements

The impact of the MDR on your role and responsibility

  • Why a change in regulation?
  • Structure of the new Regulation and flow of compliance
  • Key analysis of the changes
  • Changes to roles and responsibilities of key stakeholders
    • Competent authorities and Notified Bodies
    • Economic operators – role and responsibilities
    • Person responsible for regulatory compliance

Borderlines and classification

  • Borderline determination
  • Software qualification and classification
  • Understanding the classification process
  • Investigating the classification rules (emphasis on the new rules)

Classification workshop: Practical session in applying the new rules

Ensuring compliance

  • General safety and performance requirements
  • Changes from old essential requirements
  • Additional quality management system requirements from 26 May 2020
  • Technical documentation requirements
  • Gap analysis of MDR requirements compared with MDD

Requirements for clinical evaluations and investigations

  • Requirements, standards and guidance
  • Understanding the importance of clinical evaluation
  • Key requirements of clinical investigations

Programme day two

Market entry and post-market requirements

The new market surveillance tools

  • The European database (EUDAMED)
  • Unique device identification (UDI)
  • Supply chain surveillance and traceability

Requirements for PMS

  • Understanding PMS requirements
  • Implementing effective PMS

The new vigilance system

  • Management of adverse incidents
  • Definitions: what is reportable, the reporting process and investigation
  • Corrective action
  • Periodic safety update reports – how to manage this requirement

Vigilance workshop: Report or not to report?

PMCF studies

  • Requirements for PMCF
  • Types of PMCF

Future evolution of the European regulatory system

  • Impact of Brexit
  • How to meet UK requirements for your medical device
  • The challenge of future technology

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.

Theresa Jeary

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.

Theresa 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.

Book now

26-27 Mar 2020
26-27 Mar 2020 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
8-9 Oct 2020
8-9 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now