Navigating the Regulatory Affairs landscape: Insights from Prof. Dr. Rudolf Blankart

At the intersection of law, science, and medicine, the sitem-insel School's Medical Device Regulatory Affairs and Quality Assurance (MDRQ) program stands as a beacon for professionals navigating the complex landscape of medical technology regulation. What sets it apart? Prof. Dr. Rudolf Blankart, Professor of Regulatory Affairs, provides insightful details about the Regulatory Affairs landscape and the program.

The field of medical technology is continuously evolving thanks to the relentless pursuit of innovative solutions and advancements. Prof. Dr. Rudolf Blankart, Professor of Regulatory Affairs at the KPM Center for Public Management of the University of Bern and Director of Regulation at sitem-insel, underscores that this progressive journey from innovation to application demands a comprehensive understanding of and adherence to government obligations, market demands, and scientific conventions. “Regulatory Affairs plays a crucial role in the development and marketing of medical technologies”, he explains.

Prof. Blankart, how do you define the term “Regulatory Affairs”?

Regulatory Affairs defines a profession that involves ensuring that relevant government obligations, market driven demands, and evolving scientific conventions are understood and adhered to. Regulatory Affairs plays a crucial role in the development and marketing of medical technologies. The profession is multi-dimensional and requires a deep understanding of legal, scientific, and medical aspects.

Can you tell us about the importance of Regulatory Affairs specialists in the field of medical technologies?

Responsible persons for Regulatory Affairs all over the world play an important role in companies. They ensure safety, quality, and effectiveness of medical devices and other medical technologies, and foster innovation and efficiency in the healthcare sector.

Why is regulation in the medical technology field required?

Medical technologies should improve human lives, but they often come with side effects. Regulation must ensure that medical technologies are of high quality, have a good design, and are effective. However, effective regulations must strike a balance between preserving patient safety and facilitating the creation and implementation of innovative medical technologies despite the presence of certain risks.

Who would benefit most from the MDRQ program and why?

Awareness of regulatory requirements can improve the innovation process and its efficiency. It should not be seen as an obstacle for new innovations, but as a chance as it can provide new opportunities and improve efficiency. Our program targets individuals who have already gathered some experience in regulatory affairs or have been active in adjacent areas. The program helps them to acquire new expertise, structure their existing knowledge, and delve into specific topics. Prospective students typically have a degree in engineering, medicine, natural sciences, pharmacy, or related fields.

What distinguishes the MDRQ program from other similar programs?

Our program is run by sitem-insel in cooperation with the Medical Faculty of the University of Bern and is scientifically oriented. Students learn the theoretical foundations, methods and concepts that enable them to solve upcoming challenges in their professional lives. In this way, they not only learn the state of regulatory affairs today but are also equipped to tackle emerging regulatory challenges in the future.

What opportunities for networking and international exposure does the MDRQ program offer?

The program provides many opportunities for interaction with fellow students as well as lecturers from industry and academia. The school community benefits from regulatory context brought in from all over the world.

How does the MDRQ program equip its students to adapt to the latest regulatory changes and implementations in the medical devices industry?

Our close links to science, clinical practice and industry mean that we are often one step ahead which allows us to integrate the topics into our curriculum at an early stage. Our students then benefit from the early engagement with these complex and future oriented topics.

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Watch the full interview here.

Learn more about the MDRQ program here

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