Industry experts to deliver workshop on medical device regulation
The Regulatory Affairs Professionals Society (RAPS) is hosting a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.
The workshop – ‘EU Regulatory Essentials, Medical Device and In VitroDiagnostics: Transitioning from Current Directives to New Regulations’ – will also feature the European Commission’s policy and legal officer Salvatore Scalzo who will provide insight and an introduction to the new legislation and its implication.
Scalzo’s role at the European Commission involves negotiation of the proposed new EU regulations on medical devices and contributing to the International Medical Devices Regulators Forum.
RAPS executive director Paul Brooks said: “RAPS is committed to understanding the specific needs of European regulatory professionals and supporting our European members as they prepare for, and implement, the new regulations and we are delighted to announce Salvatore Scalzo’s attendance.
“This workshop is a ‘can’t miss’ opportunity to learn from a select group of experts, including the European Commission’s MDR point person, and regulatory professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations.”
The programme’s list of speakers include:
· Rainer Voelksen, FRAPS, vice president, regulatory and quality affairs, Occlutech
· Anja Wiersma, PhD, CEO and senior consultant, mi-CE consultancy
· Gert Bos, PhD, FRAPS, executive director and partner, Qserve Group
· Yvonne Middlefell, BA (Hons), RAC, FRAPS, senior director, Stellar Regulatory Consulting Ltd.
· Sabina Hoekstra-van den Bosch, MSc, PharmD, FRAPS, lead for European regulation global regulations and standards, Philips
· Bassil Akra, PhD, director, Clinical Centre of Excellence, TÜV SÜD, Product Service GmbH
· Rima Padovani, PhD, project associate, Medidee Services
· Michael Maier, senior partner, Medidee Services
The show will include two general sessions relevant to all device/IVD manufacturers along with two comprehensive tracks that look at the specifics of the new MDR and IVDR. The tracks will examine the new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements.
“Highly regulated environments such as the medical device sector will always be subject to development and change. The new medical device regulations in Europe present a huge challenge to manufacturers but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.
“By the end of our workshop members will be aware of the key changes introduced by the new regulations. They will also have received expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE marking) expectations for both new and legacy devices being placed in Europe.
“If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable as you prepare for the 2020 deadline.” Brooks continued.
