Trainings By Informa Markets

Advanced Workshop on Signal Detection & Medical Device Vigilance

28 May - 29 May 2024

Workshop Overview

Workshop Trainer: Dr. Graeme Ladds

This two-day course offers an updated and pragmatic view of the requirements for signal detection as mentioned within the legislation and its practical implementation. Signal analysis and determination also requires appraisal for all confirmed signals of the overall influence of such new signals on the benefit-risk profile of the product including and risk minimisation activities proposed as a result of identifying the new signal.

This course works as an excellent introduction for those wanting to understand the evolving safety profile of a product from the clinical and into the post marketing phase and the impact on labelling; safety education, Risk Management/Minimisation plans, updates in periodic reports including any events of special interest.

The second day of the course focuses on the recent updates and changes with Medical Device Vigilance and the enhanced safety requirements together with the changes that have happened with the UK not adopting the new EU Medical Device legislation and the impact on existing medical devices and new ones coming to market. The course will be interactive with a combination of course lectures, discussions, questions and solutions.

Program Focus

The overall aim is to understand how to manage the safety life-cycle of the Company products whether in clinical development or post-marketing.

Additionally, day 2 of the course looks at the safety of Medical Devices through the introduction of the new EU Legislation which came into force in May 2021 & 2022.

Specific objectives are:

  • To provide a clear approach to signal detection.
  • Identify how to translate signals into practical safety information to explain how products can still be used effectively.
  • To provide an overview of the digitalisation opportunities in the pharmaceutical industry that will contribute to earlier and better signalling.
  • Changes imposed by the new EU Medical Device Legislation
  • The impact of those changes in terms of enhanced safety monitoring
  • The implication of Brexit on Device Vigilance

Benefits of Attending

After the course the delegates will understand:

1. The lifecycle expectations of product safety management.

2. The importance of Risk-Benefit approaches

3. The science and risk-based approach to signal analysis and risk minimisation approaches

4. New legislation changes in the EU for Medical Device Vigilance

5. The effect of Brexit on Pharmacovigilance activities

Who Should Attend?

This course is relevant to professionals involved in the pharmaceutical industry with the following background:

  • Pharmacovigilance Personnel
  • Regulatory Affairs
  • Quality Assurance especially those involved in PV audits
  • Clinical Personnel
  • Medical Device Professional
  • Medical Affairs Personnel

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