Hosted by Elizabeth Hunt and with guests comprising of leading industry figures, the PharmaLex Talks podcast is a place for discussion on important topics within the Pharmaceutical and Pharma-adjacent sectors.
How the MDR has changed the roles and responsibilities of “economic operators”
Under the Medical Devices Regulation economic operators – that is manufacturers, the authorised representative, importers and distributors – all face new roles and obligations. While some of these responsibilities existed under the Medical Devices Directive, workload will be impacted. From requirements around Eudamed, to having a person responsible for regulatory compliance, to ensuring certain obligations are properly followed through to complaint management, the roles of all economic operators are affected and require careful consideration by companies with devices in the European market.
Clare Huntington is Director and Head of Medical Devices / IVD UK at PharmaLex
Clare leads the UK and EU teams and consults on industry-wide issues including drug/device combination products, clinical trials, device classification and regulatory submissions, and post-market requirements. Clare has worked in a variety of roles in the medical device space during her career, including the MHRA, a Clinical Research Organisation, as an EU Authorised Representative, as well as industry, leading the regulatory affairs activities. This has given her a broad understanding of the EU regulatory landscape which enables her to provide comprehensive advice to clients that covers the full product life-cycle.
The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance
The next frontier in outsourcing is the management of established marketed products, which provide the opportunity to sustain revenue, keep maintenance costs low and ensure compliance of mature products.
Solving the Innovation Dilemma with Integrated Product Development
A recent survey of senior pharmaceutical and biotech executives explores why IPD programs are becoming an increasingly important strategy to successfully bring a new drug to market.
To find out more, we speak with Frédéric Pailloux, Senior Director, Head of Integrated Product Development & Consulting, at PharmaLex.
How software is changing the use of and types of medical devices
Classification and regulation around medical device software has become more complex, and in recent years most regulatory authorities have tightened the regulatory pathways. The podcast explores software differences and how these impact regulator classifications in various markets. It also looks at key considerations for managing the oversight of these products, in particular with regards to a quality management system.
Yervant Chijian, Director, Team Lead Medical Devices / IVD, Australia
Yervant provides expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access. He has spent the last 20+ years in the Medical Device field, including both manufacturing and product development. His expertise lies in Regulatory Strategic Planning, particularly in the United States, Europe, Canada, Australia, and New Zealand markets, and in Product Development and Design Controls, specifically in software and with active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management, he brings a comprehensive skill set to support clients navigate through the variety of regulatory pathways and requirements.
Annex 1 – Are you ready for implementation of the new Annex?
Some major changes have been outlined in the EU Annex 1 Revision. Listen to PharmaLex expert Patrick Nieuwenhuizen on how the industry can implement the new Annex 1.
Getting Ready for the IVDR
IVDR Brings Huge Change to Manufacturers Distributing Products in Europe
The In Vitro Diagnostic Regulation (IVDR) means enormous upheaval for companies, as now up to 90% of products will need to be reviewed by a notified body before they are eligible for distribution in Europe under the IVDR. That’s a huge about-turn from the situation under the In Vitro Diagnostic Directive (IVDD), where approximately 80% of products were self-declared to the IVD Directive.
Listen to our expert, Terrance Thiel, in the latest PharmaLex podcast to learn more.