Regulatory science workshop for medical devices, NAMs and medicinal products

Understanding and implementing regulatory science can be complex and time consuming and requires interaction with regulators and notified bodies. CoLAB TRIALS can shed light on how to streamline this process for your health product/service/method. This workshop is directed to EIC Pathfinder, EIC Transition and EIC Accelerator, innovators that develop health products/services/methods, such as Medical Devices (including SaMD and IVD), New Approach Methodologies (NAMs including Biomarkers), and Medicinal products (including Pharmaceuticals and Advanced Therapy Medicinal Products). This online workshop will be designed to meet the specific needs of the health innovators, who can select a 1-hour, half-a-day or full-day workshop (in English). The workshop's goal is to capacitate the innovators with knowledge and skills that enables them to plan the collection of appropriate and robust scientific and clinical evidence during product's development and testing, aligned with the regulatory requirements. The workshop will cover the regulatory science principles and goals, journeys of innovative health products, product classification, EU regulatory landscape (ex. MDR, IVDR, CTR), non-clinical, clinical and ethical guidelines and recommendations, clinical investigations, supporting mechanisms. The level of details in the topics will be presented according to the requested duration of the workshop and type of health product/service/method. Also, according to the workshop duration, knowledge testing (ex. quiz) and Q&A may be included. In the end of the service, EIC beneficiaries will be capable of clearly understanding where regulatory information can be found, which guidelines and regulations could be applicable to their product/service/method, which supporting mechanisms could be applicable and used.