The event will take place in Brussels on 20 November 2018 hosted in collaboration between RAPS and TOPRA
The Regulatory Affairs Professionals Society (RAPS) and The Organisation for Professionals in Regulatory Affairs (TOPRA) have joined forces to deliver a workshop to help regulatory professionals understand the impact of the EU’s new Medical Device Regulation (MDR) on combination products.
The workshop, entitled Addressing the Impact of the EU MDR on ‘Combination’ Products, will take place at the Radisson Blu Hotel in Brussels on 20 November 2018. It will bring together representatives of the European Commission, Member State medicinal and medical device authorities, notified bodies and industry experts to explore the complex issues of MDR specific to combination products.
The workshop will include a brief review of the changes MDR will introduce, but more time will be devoted to discussing the anticipated practical implications of the changes
The goal of the workshop is to generate white papers highlighting practical considerations to be shared with regulators and other stakeholders as they deliberate on implementation issues.
Paul Brooks, executive director of RAPS, commented: “MDR is the single biggest challenge currently faced by those involved in the regulation of healthcare products. Combination products are particularly challenging to manage, and collaboration across the sector is essential if we are to consistently understand the regulators’ interpretations and expectations in meeting the new requirements.”
The workshop will include a brief review of the changes MDR will introduce, but more time will be devoted to discussing the anticipated practical implications of the changes and sharing the concerns and expectations of all stakeholders as the regulators establish future implementation expectations.
Lynda Wight, TOPRA executive director, added: “One of the biggest challenges associated with MDR is the potential for differences in interpretation of the new requirements. We all need to work together to help facilitate consistent expectations by all involved and to make sure the professional community is prepared.”
Both CEOs agree that by bringing together representatives from regulatory agencies and other key stakeholders, they can help provide greater clarity and help manufacturers better appreciate the new expectations for both categories of combination products—those regulated as devices and those regulated as medicines—as well as the implications for both currently marketed products and for new ones.
“As MDR is such an important issue, we are pleased to work in partnership to support regulatory professionals in Europe with the highest quality education and training to help them meet their regulatory responsibilities,” they say.