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Overview
The scope of this Workshop is Drug-Device Combination Products that are regulated as medicinal products in Europe. Here, we will have the opportunity to continue the dialogue started at the EMA sponsored workshop that took place in November 2020 and will focus on the current significant challenges brought by Article 117 of the European Medical Device Regulation (MDR), which came into effect in May 2021. This workshop will provide a neutral platform for the various stakeholders to discuss the issues and potential solutions to these challenges, with the aim of creating a consistent and predictable regulatory environment for this increasingly important category of medicines.
Featured topics
- Challenges related to the implementation of MDR Art 117
- Role and remit of key Stakeholders – EMA, Competent Authorities, Notified Bodies and Industry
- How to increase clarity and predictability of regulatory expectations related to:
- Clinical Trials
- New Product Submissions
- Changes and Lifecycle Management
Who should attend?
Professionals involved in:
- CMC Regulatory Affairs
- Device Regulatory Affairs
- CMC Policy
- Device Policy
- Global Development
- Regulatory Convergence and Reliance
- Regulatory Compliance
- Regulatory Policy
- Technical Research and Development
- CMC Lifecycle Management
- Device Lifecycle Management
- CMC Project Management
- Device Project Management
- Medical Devices and Combination Products
Learning objectives
In this Workshop we will:
- Discuss the challenges related to the implementation of MDR Art 117, including the role and remit of the key stakeholders
- Explore options for ensuring the effective and efficient regulatory oversight of Drug-Device Combination Products that fall within the revised legal framework introduced by Article 117 of the MDR
Program Committee
-
Amanda Matthews • Senior Director, GCMC for Combination Products & Medical Devices
Pfizer R&D UK, Ltd, United Kingdom -
Bjorg Hunter, MSc • Director
Novo Nordisk, Denmark -
Tim Chesworth • Senior Director Regulatory Affairs
AstraZeneca, United Kingdom -
Christelle Bouygues • Acting Head of Regulatory Affairs, Office Scientific and Regulatory Management
European Medicines Agency, Netherlands -
Ilona Reischl, PhD, MPharm • Biologics Quality Assessor
Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
