Develop and Validate new digital Tools for clinical Project Management and Regulatory Support

Plan and guide the implementation of regulatory roadmap for increasing TRL of innovative health products (TRL 4-6). Medicines (including ATMP), Medical devices, IVDs and Biomarker Validation. Streamline interactions with regulators and Notified Bodies. Identification and interaction with critical partners. Project planning and implementation.

Design and plan innovative pre-clinical and clinical studies (TRL 4-6) according to scientific regulatory requirements for Medicines (including ATMP), Medical devices and IVDs. Streamline interactions with regulators.

Workshops (12 h) on:

• medical device certification for innovation hubs/Test -Beds
• international funding for healthcare professionals

Engage associates and other stakeholders in EU consortia to participate in international clinical studies