Our head of clinical trial regulatory management in Western and Central Europe, Rainer Porrmann, PhD, will share his expertise at DIA 2015 June 17, in Washington, D.C. His presentation, “Current Situation and Potential Future Development of Regulatory Requirements,” takes place in the medical devices/in vitro diagnostics and combination products track and will provide an overview of the current regulatory requirements for clinical trials for medical devices in Europe and key factors of the proposed new European regulations.
Unlike the pharmaceutical side of clinical trials, there is currently no separate regulation or directive that defines the requirements and procedures for medical device trials in detail. This can sometimes lead to some insecurity for non-EU sponsors planning or conducting medical device trials in EEA countries.
During his presentation, Rainer will discuss the current regulatory framework in Europe for medical device trials, explaining similarities and differences that show the range of potential variability across Europe. In addition, he will highlight key factors of the proposed new European regulations and provide an update about their development to help prepare for the upcoming changes. Attendees will gain an understanding of key implications for sponsors in regards to trial planning, the submission process, timelines, and conducting clinical trials with medical devices in the EEA.
DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and life-cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. This annual meeting provides thought leaders, decision makers and patient advocates with the opportunity to collaborate and share knowledge with the top minds in medicine. To learn more about their annual conference or register, visit their website.
Leave us a comment or contact our team if you plan to attend DIA 2015. We would love to connect you with Rainer to learn more about regulatory requirements in Western and Central Europe.