DIA and RAPS Open Registration for “2024 Combination Products in the EU” Summit
DIA and the Regulatory Affairs Professionals Society (RAPS) have come together for the first time to produce “2024 Combination Products in the EU,” a summit convening 30-31 January at the Radisson Grand Place in Brussels. This highly interactive event will unite stakeholders across the field—including representatives from European Medicines Agency (EMA), the European Commission, notified bodies, and national competent authorities and industry—to explore a coordinated drug and device approach to incentivize competitive innovation in Europe.
With a focus on finding solutions and creating efficiencies, 2024 Combination Products in the EU will offer delegates a comprehensive overview of the status of the EU medical devices regulation (MDR) implementation, examine the nuances of Article 117, and discuss the process of obtaining notified body and competent authority opinions. In addition, the event will provide a unique forum for discussing the implications of the new EU pharmaceutical legislation on bringing combination products to market.
By exploring challenges and opportunities to unite for a better way forward, the programme will explore challenges and opportunities within critical topics such as labelling, connected devices, software as a medical device, clinical trials, post-marketing clinical follow-ups, sustainability, and the application of human factors engineering.
“Innovation and industry collaboration in combination products is greatly needed in the EU to address ever-changing regulations and patient needs,” said Ania Mitan, Senior Vice President & Managing Director, EMEA and India, DIA. “This summit will bring together trailblazers and pioneers across the field to stimulate much needed conversations that explore practicalities and roadblocks toward modernization and advancement.”
Throughout the summit, experts will participate in working groups to stimulate ideation and innovation around designing solutions for pragmatic implementation.
“DIA and RAPS are the perfect partners to deliver an event like this for the EU,” said RAPS Executive Director Bill McMoil. “Leveraging our combined reach into the medical device and pharmaceutical sectors, we can deliver an engaged audience of professionals across all disciplines to work together for the betterment of patient care. We look forward to many future collaborations like this to support the industry.”
The programme agenda is being curated by experts across the combination products community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. Planning committee members include:
- Christelle Bouygues, Regulatory Affairs Senior Officer, European Medicines Agency (advisor)
- Tim Chesworth, Senior Director Regulatory Affairs, Astra Zeneca
- Theresa Jeary, Technical Specialist and Scheme Manager, BSI
- Sabina Hoekstra-van den Bosch, PharmD FRAPS, Global Director Regulatory Strategy, TÜV SÜD Medical Health Services, Netherlands
- Amanda Matthews, Senior Director, Regulatory CMC for Combination Products and Medical Devices, Pfizer
- Thomas Wejs Møller, Director Global Regulatory Affairs - Devices, Novo Nordisk
- Sophie Tabutin, EMEA Regulatory Affairs Leader, W.L. Gore
- Anja Wiersma, CEO and senior consultant, mi-CE consultancy
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ABOUT DIA
DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.
DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East, and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).
Learn more at DIAglobal.org and connect with DIA on Twitter, LinkedIn, Facebook, and Instagram.
ABOUT REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. www.raps.org
