Webinar: Clinical Development Unlocked – A roadmap from research to clinical products -current insights on strategies, costs and challenges from BioRN members

Clinical Development Unlocked –

A roadmap from research to clinical products -current insights on strategies, costs and challenges from BioRN members

Bringing a medicinal product or medical device from development to clinical investigation requires a clear regulatory strategy, careful planning, and a thorough understanding of sponsor responsibilities.

This webinar provides a practical overview of the regulatory landscape for medical devices, medicinal products, and Advanced Therapy Medicinal Products (ATMPs), with a focus on key European regulatory authorities, including the EMA, PEI, and BfArM.

The webinar is facilitated by: Dr. Rico Laage, Guided Development, Cornelia Grossrubatscher, FGK Clinical Research and Martin Krauss, FGK Clinical Research.

Participants will gain insights into the journey from early planning to clinical trial submission, exploring key success factors, potential hurdles, budget considerations, and the role of Contract Research Organizations (CROs). The session will also cover the value of scientific advice, Clinical Trial Applications (CTAs), and strategic decision-making to support an efficient and successful submission process.

Finally, the webinar will address what it takes to become a sponsor, outlining the essential responsibilities for regulatory compliance, quality management, partner selection, and effective oversight of outsourced activities.

Whether you are preparing for your first clinical trial or looking to strengthen your regulatory and operational strategy, this webinar will provide practical guidance to help you navigate the pathway from development to clinical investigation with confidence.