Medical Device Studies: Regulatory Requirements and Adverse Event Reporting (London, United Kingdom - October 12, 2018)

  • ID: 4435506
  • Conference
  • Location: London, United Kingdom
  • 1 Day
  • Management Forum
  • Conference Dates: October 12, 2018
1 of 4
Including an Update on the Implications of the Regulatory Changes

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting

Course Overview

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting for medical device clinical studies complying with the European Medical Device Directive 93/42/EEC. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period.

By attending this meeting you will:

  • HEAR all you need to know about the regulatory requirements for monitoring and reporting adverse events in one information packed day
  • FIND OUT when a clinical investigation is need
  • DISCOVER the requirements for vigilance reporting
  • UNDERSTAND the main changes involved with the new Medical Device Regulations
  • APPRECIATE the role of The Competent Authority and how to, when to, and what to communicate with the authority

Topics covered include:

  • The regulatory requirements for monitoring and reporting adverse events during medical device studies
  • How to define and classify adverse events
  • Clinical investigations and evaluations
  • PMS and post-market clinical follow-up studies
  • Vigilance reporting
  • The role of the Competent Authority

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

READ MORE
Note: Product cover images may vary from those shown
2 of 4

09.30                           Welcome and introduction

09.45                Clinical investigations and evaluations - when is an investigation needed?
How to perform a clinical evaluation
When are clinical investigations needed
The regulatory requirements

10.35               PMS and post market clinical follow up studies
What is PMS
What do the regulations entail
When are PMCF studies necessary

11.00                 Refreshments

11.15                 Vigilance reporting
What is vigilance
The requirements for vigilance reporting

11.45                     How to define and classify adverse events

  • Definitions
  • Types of events
  • Determining categories

12.15                        The regulatory requirements for monitoring and reporting adverse events during regulatory and post market clinical follow up studies

  • MEDDEV guidance document
  • ISO 14155 harmonised standard
  • Responsibilities
  • Post market clinical follow up studies

12.50              Discussion

13.00                 Lunch

14.00                 Vigilance workshop

14.30             The new Medical Device Regulations

  • Structure and overview of the new regulation
  • Some of the main changes
  • Final provisions – transitional arrangements

15.30              Discussion

15.45                Refreshments

16.00              The new Medical Device Regulations - clinical elements

  • Focus on changes in the clinical arena
  • Chapter VI Clinical Evaluation and Investigation
  • Annex XIV Clinical Investigations

16.40              The role of the Competent Authority (CA)

  • What is the involvement of the CA
  • Communicating with the CA
  • What to communicate and when

17.00                 Discussion and end of forum

Note: Product cover images may vary from those shown
3 of 4

Loading
LOADING...

4 of 4
  • Regulatory affairs specialists
  • Quality assurance specialists
  • Clinical research associates
  • Junior clinical research associates
Note: Product cover images may vary from those shown
5 of 4

ADDRESS

Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom


DIRECTIONS

The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

Note: Product cover images may vary from those shown
Adroll
adroll