Thomas Wejs Møller (Chair)

Section Manager – Medical Devices, Danish Medicines Agency, Denmark

Thomas is an experienced manager in the public sector and has achieved good results with strategy, efficiency and management projects in health care, environmental and engineering field.

As section manager of medical devices in the Danish Medicines Agency Thomas works with the Danish health care sector, medtech industy and Patient-NGOs to secure patient safety.

Thomas holds a masters degree in political science from the University of Copenhagen, he has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience from the public sector.

“Denmark shares the same challenges as many other countries – in trying to keep up with the implementation challenge and the developments with new and innovative products that keep on challenging our regulations. It is necessary that the countries in Europe work together – and share our best practices and our resources.

“I believe we are here to improve patient safety as we do that every day through our work with market surveillance. With the challenges ahead of us – with both new technology and new regulations – I believe that if we work together we are able to make the change and jump to the next level – of regulation – and control. That is my aim in the CAMD Executive Group.”

For more information: www.linkedin.com/in/thomas-w-møller-a28587

THWM@dkma.dk

+45 9359 6475

Dr. Helena Dzojic

Head of Department of Medical Devices, the Medical Products Agency, Sweden

Helena holds a PhD in Clinical Immunology from Uppsala University and has nearly five years of research experience within the field of immunotherapy. Since 2011 she has held the role of Head of the Department for Medical Devices at the Medical Products Agency in Sweden where she has had several roles since 2007. Helena also has broad experience in the field of regulation and market surveillance of medical devices.

Furthermore, she has experience of working in several EU working groups such as MD IVD, MD Compliance & Enforcement (COEN) WG, Medical Devices Experts Group (MDEG) and MD Regulatory Committee. She is also member of The Market Surveillance Council, a national coordination body for market surveillance in Sweden.

helena.dzojic@mpa.se

+46 70 213 95 03

Niall MacAleenan

Medical Device Lead, Health Products Regulatory Authority (HPRA), Ireland

Niall is the Medical Device Lead and Clinical Assessment & Policy Manager for medical devices at the Health Products Regulatory Authority (HPRA) in Ireland. At the HPRA he is responsible for coordinating medical device activities with specific operational focus on market surveillance of medical devices, notified body designation & oversight and assessment of clinical investigations and clinical evaluation of medical devices.

Niall is a member of a number of different EU working groups on medical devices including the Medical Device Expert Group (MDEG), the Medical Device Regulatory Committee, the Clinical Investigation and Evaluation Working Group (CIEWG) and the Notified Body Operations Group (NBOG). He is a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF).

Niall is a medical doctor with a broad experience in hospital medicine having completed general professional training in internal medicine. Niall’s clinical research interests included endoscopic screening for gastrointestinal malignancy and antimicrobial resistance patterns for Helicobacter pylori. In addition to his medical degree, Niall also holds a Masters in Business Administration.

niall.macaleenan@hpra.ie

+353 1 6343428

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