Key Takeaways
- The new training course focuses on market access for medical device software amid rising demand for digital health solutions.
- Participants will learn about country-specific regulations, approval processes, and reimbursement pathways globally.
- Designed for professionals in various roles, the course includes hands-on exercises and case studies for practical insights.
Course Overview
ResearchAndMarkets.com has launched the “Global Market Access for Medical Device Software Training Course,” aimed at helping professionals understand the intricacies of international market access requirements for medical device software. As the demand for Digital Health (DH) solutions accelerates, mastering international regulations is crucial for successful market entry.
The course will prepare attendees to navigate unique market access landscapes, enhancing the likelihood of commercial success by familiarizing them with country-specific requirements. With evolving regulatory standards, there is a shift towards value-based pricing and reimbursement mechanisms, prompting numerous countries, including those within and outside the European Union (EU), to implement various authorization and access schemes for digital health technologies (DHTs).
This intensive program will provide a thorough examination of the different national DHT market access and reimbursement strategies and will highlight best practices across various global jurisdictions. Participants can expect an interactive format, featuring real-life examples, hands-on exercises, and case studies that will equip them to make informed decisions affecting market access processes.
Key topics covered will include:
- Impact categories of digital health technologies (DHTs)
- Market Authorization vs. Market Access
- Coverage and Health Technology Assessment (HTA)
- Reimbursement pathways specific to EU Member States
- Global reimbursement landscape analysis, including insights from the USA, UK, South Korea, and Japan
By attending the course, professionals can gain essential knowledge to effectively navigate complex market environments, optimize product development for various markets, and ultimately enhance their chances for commercial success.
The course is suitable for a wide range of professionals, including regulatory affairs managers, business strategists, product and service managers, and legal representatives, among others. Participants will receive a certificate of completion and 6 hours of Continuing Professional Development (CPD) credits.
The training will be facilitated by Catarina Carrão from BioSciPons, a specialist in clinical evaluation with extensive experience in the regulatory landscape. Her background in neuroscience, cardiovascular, oncology, molecular biology, and biostatistics positions her as an expert in guiding medical device manufacturers through certification processes.
For more details about this training, visit ResearchAndMarkets.com.
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