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Advanced Regulatory Affairs for Medical Devices Training Course

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

★★★★★ "Everything good. Even though all different countries' people took this course, but the speakers cons... more"

2-3 Feb 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

Enrol or reserve

The Advanced Regulatory Affairs for Medical Devices course will cover:

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 on applying the new rules

GSPRs Annex I Requirements


Requirements for clinical evaluations and investigations

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

Clinical evaluation and investigation workshop: Consolidating the key requirements

Conformity assessment

  • Various conformity assessment routes
  • Scrutiny process and key considerations
  • Selection of and engagement with your Notified Body

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 Medical Device Legislation

  • UKCA Marking

Enrol or reserve

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.

More details

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.

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.

More details

Book Advanced Regulatory Affairs for Medical Devices Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

2-3 Feb 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12483

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 29 Dec

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Not ready to book yet?

for 7 days, no obligation

6-9 Jun 2023

Live online

13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 12339

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 02 May

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Not ready to book yet?

for 7 days, no obligation

9-10 Oct 2023

Classroom
Rembrandt Hotel
London

Course code 12710

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 04 Sep

  • 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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Advanced Regulatory Affairs for Medical Devices training course


Everything good. Even though all different countries' people took this course, but the speakers considered many details for them until end of course. I am really thankful that you gave us opportunities to have much time and appreciated with you.

Sep 27 2022

Heejun Hong
Student, Dongguk University, Republic of Korea

Sep 27 2022

[I liked] the speed, the content. The workshops: had some nice discussion in the breakout room with participants that joined with a microphone (and camara). Clarification on PMCF.

Jennie Mettivier Meijer
Project Manager Medical Devices & Quality Systems, BioTop Medical

Sep 27 2022

Both speakers are excellent communicators and pleasant persons. Slides were clear.

Teresa Lopes
Manager Medical Devices, BioTop Medical

Sep 27 2022

I less like working in groups and more prefer presentations and detailed explanation of all the exercises by the speakers. Very good webinar!

Elen Lasri
RA specialist, Elcam Medical Acal Ltd

Sep 27 2022

I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.

Lim KyoungYoon
Smart Life Care Solution Laboratory, Dongguk Univ

Sep 27 2022

I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.

Lim KyoungYoon
Smart Life Care Solution Laboratory, Dongguk Univ

Apr 20 2021

This webinar met all my expectations. The content and presentations was very interesting and the speakers were great.

Sophie Lamaison
Blue Reg

Apr 20 2021

The content was very good, the presentation was clear and the speakers were didactic

Gabriela Rodrigues
Regulatory Affairs Specialist, DKT Woman Care

United Kingdom

  • Blue Reg Pharma
  • Corin Limited
  • Kyowa Kirin International
  • N/A
  • Pennine Healthcare Ltd
  • Presspart

Korea, Republic Of

  • Dongguk Univ
  • Dongguk University
  • Dongguk University, Republic of Korea

France

  • Blue Reg
  • DKT Woman Care

Netherlands

  • BioTop Medical
  • Veeva Systems

Israel

  • Elcam Medical Acal Ltd

Enrol or reserve

Run Advanced Regulatory Affairs for Medical Devices Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy