This session provides practical insights into planning and executing clinical trials in Europe, focusing on operational excellence and strategic use of Scientific Advice. It covers efficient navigation of CTIS, including country selection, timelines, and ways to accelerate approvals while ensuring compliance. In addition, it highlights how Scientific Advice can de risk development, align with regulators, and optimise pathways. Participants will gain actionable insights to manage complexity, avoid pitfalls, and enable timely, successful clinical development.
Tuesday, May 5, 09:00 - 09:45, room Singapore
| Name | Position | Institution |
|---|---|---|
| Ursula Türcke | Senior Director Clinical Operations | FGK |
| Name | Position | Institution |
|---|---|---|
| Dr. Stephanie Krumholz | Founder and CEO | therainnova AG |
| Martin Krauss | Founder and Managing Director | FGK |
therainnova AG provides strategic and operational regulatory affairs support in the EU and Switzerland for biopharmaceutical companies. Working with trusted partners, we offer a one stop shop across all development stages, from early phase to post marketing. Services include regulatory strategy, submissions, project management, and interim leadership. With expertise in small molecules, biologics, and biosimilars, we support efficient market approvals and value creation, including due diligence for portfolio optimisation.
A independent and owner- managed clinical full-service CRO, est. 2002., with HQ in Munich, a branch office in Berlin and subsidiaries in CZ, HU, PL, the UK and the US. FGK specializes in collaborating with biotech, medical device, and pharmaceutical companies and has been conducting Phase I- IV trials for > 23 years. Its 240 employees form an organically grown team of highly qualified medical, scientific, and regulatory experts who provide tailored solutions for every sponsor. Experienced in all major indications e.g. oncology, CNS, etc., advanced new therapies, rare diseases.
