This course will provide a clear understanding of different market access requirements for medical device software.
As demand surges for Digital Health (DH) solutions worldwide, understanding and navigating international regulations is paramount for market access success. This course will equip professionals with the knowledge to successfully enter into different international markets, improving the chances of commercial success by understanding country-specific requirements.
With an increased impact on clinical management, a higher bar for evidence is required for regulatory approval and adoption, but also an increased stakeholder willingness to pay for the service provided. Although at the moment, there’s no one-size-fits all approach, there is a global trend to increase DHT adoption through value-based pricing and reimbursement mechanisms. This growing trend has prompted countries, both within and outside the European Union (EU), to pilot various market authorization and access schemes, providing guidelines for coverage, and/or clear pathways for reimbursement of DHTs. This intensive course provides a comprehensive overview of the different national DHT market access and reimbursement strategies, presenting an overview of the current state of affairs.
The program will be highly interactive, using real-life examples and state-of-the-art practices across different global jurisdictions. Practical insights will be provide, hands-on exercises, and case studies to guide you through the intricate decisions needed that affect your market access processes.
The course will cover:
- Impact categories of digital health technologies (DHTs)
- Market Authorization vs. Market Access
- Coverage and Health Technology Assessment (HTA)
- Specifics of reimbursement pathways for DHTs across EU Member States
- The new Health Technology Assessment (HTA) Regulation, EDiHTA, and ASSESS-DHT
- Outside of the EU Member States: global reimbursement landscape (e.g., USA, UK, South Korea, Japan, among others)
Benefits of attending
- Gain an in-depth knowledge to navigate complex market access environments
- Ensure successful entry into international markets
- Streamline product development to entry different markets
- Improve the chances of commercial success by understanding country-specific requirements and approval processes.
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Day 1
- Impact categories of digital health technologies (DHTs)
- Market Authorization vs. Market Access
- Coverage and Health Technology Assessment (HTA)
Day 2
- Specifics of reimbursement pathways for DHTs across EU Member States
- The new Health Technology Assessment (HTA) regulation, EDiHTA, and ASSESS-DHT
- Outside of the EU Member States: Global reimbursement landscape (e.g., USA, UK, South Korea, Japan, among others)
Speakers
Catarina Carrao,
BioSciPonsCatarina Carrão from BioSciPons, is a clinical evaluation and benefit-risk assessment specialist. Previously, she studied Biochemistry and worked in academic research. In 2006, she was a Marie-Curie Early Stage Researcher in the Universitätsmedizin Charité Berlin. In 2011, she was a Postdoctoral fellow at the University of Yale Cardiovascular Research Centre (YCRC). In 2012, she received the European Science Slam title. In 2013, she was awarded Fellow of the American Heart Association (FAHA). In 2021 she was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).
Her scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allows her to understand the needs of innovative medical device manufacturers; and support them in navigating the regulatory waters of certification. By understanding the importance of evidence, not only in written form to peers but also to deliver valuable information to the consumer, BioSciPons is favoured by start-ups in the fields of artificial intelligence, wearables, implants, among other innovative technologies.
Who Should Attend
This course is for any professionals involved in market access for medical devices, including:
- Regulatory Affairs Managers
- Business Strategists
- Product and Service Managers
- Sales and Marketing Managers
- Legal Professionals
- Compliance Officers
- Research and Development Engineers
- Clinical Research Associates
- Project Managers
