Purpose and outcome 

Clinical evaluation is a critical part not only of product validation but should play an important role throughout the full product lifecycle. This is the approach that the new ISO 18969 takes and is being received at this early stage in a very positive manner by many stakeholders including notified bodies.

Content

In this course you will learn the integrated approach of the clinical evaluation process and its important links with risk management, R&D, clinical investigations, regulatory, reimbursement and post market clinical follow up. The moto is breaking the silos, but that is easier said than done. Participants will acquire a practical and in-depth understanding of the integrated approach and are guaranteed to bring important messages back to the office to work on the integrated approach that will contribute to not only efficiency but better chances in getting a fast-track with their notified bodies as they will have it right!

Furthermore, the link between clinical evaluation and clinical investigations at the level of strategic development of the clinical development plan will be covered in depth providing a valuable input on how to plan the clinical investigations efficiently. An overview of the latest changes of ISO 14155 will also be covered in this course.

Practical examples will be provided on how to prepare a clinical strategy for Europe, while also integrating the requirements of other geographic regions - such as the US, China, and ASEAN countries - into a global strategy.

The course will be conducted in English, alternating between lectures and studies.

Who should attend

This course is targeted towards medical writers, clinical project managers, clinical research associates and others working in the field of clinical investigations of medical devices including new notified body clinical reviewers and regulators.

Trainer

Danielle Giroud, CEO, World Medical Device Organization and
CEO, MD-CLINICALS, convenor of TC 194 WG 4 (ISO 18969 and ISO 14155)

What previous participants said (Fall 2024)

"Based in the Danilles solid experience, she was able to put things in context and she was able to provide a solid answer to every questions raised at the course. You could feel her passion for the clinical field"

"The speaker is very skilled"

"Danielle Giroud was very present, engaged and used her slides as backup but did not just read them. She had many examples and was open for questions which she used as examples"

"Good overview presentations with many relevant and interesting examples from real life"