Streamline Compliance and Expedite Patient Access at RAPS Euro Convergence

Amra Racic is VP of Global Government Strategy for MedTech at Veeva Systems. With over 23 years in healthcare, primarily in regulatory roles at large medical device companies like Abbott, Bayer, and Medtronic (13 years in global regulatory advocacy, strategy, and intelligence), she now builds strategic partnerships for Veeva, tracking industry trends and promoting technology in medical device conversations. Amra also teaches International Regulatory Affairs at St. Cloud State University.

With nearly 20 years of experience in multinational corporations, Michael has a proven track record as a people leader in both technical and management roles across Regulatory, R&D, Innovation, and Project Management. His focus is on building high-performing, cross-functional teams within complex organizations. Michael achieves this by combining strategic and technical expertise, always placing the team and its leaders at the forefront.

Erik specializes in EU and national medical device law (including AI, batteries, REACH, data protection), and is an expert in EU and Dutch life sciences regulation, focusing on contracts, regulatory litigation, and M&A. Trained in IP and competition law (European Commission), he has experience in contentious, commercial, and transactional work at international law firms. Erik actively contributes to EU and national law/policy and advises EU member states on MDR/IVDR implementation.

Hilary Ann Baldwin is a highly experienced professional with over 20 years of expertise in regulatory and quality management within the pharmaceutical, diagnostic, and medical device industries. She has held key leadership roles at prominent companies such as Eli Lilly, Roche, Covance, Stryker, Caris Life Sciences, and SimBioSys. Hilary's extensive background includes managing regulatory submissions, developing global regulatory and clincal strategies, and collaborating with regulatory bodies such as the FDA and PMDA. She has over 20 years' experience in regulatory and quality in the pharmaceutical, diagnostic, and medical device industries, such as:

• SimBioSys
• Caris Lifesciences
• Stryker
• Eli Lilly

Gertjan Geelen holds two Master of Science degrees in Electromechanical and Biomedical Engineering from the KU Leuven in Belgium and has been working in the medical devices industry for nearly a decade.

Over the years he has gained extensive understanding of standards and regulations and applied his know-how to multiple small, medium-sized and corporate medical device companies for diverse products, ranging from class I, IIa/IIb and III devices to combination products, IVD devices and medical device software. By setting up quality management systems, Design History Files and technical documentations, he has guided manufacturers toward ISO certification, CE conformity and FDA clearance as lead auditee in notified body audits and FDA inspections.

Gertjan is currently spearheading the Quality Assurance and Regulatory Affairs department of dsm-firmenich Biomedical, serving as Management Representative and Person Responsible for Regulatory Compliance for the Netherlands site in its capacity as EU Authorized Representative for the US site related to the EU MDR.