Early Phase Complex Clinical Trials - Strategic Considerations for Study Design in Phase I/IIa Trials

- General scope of phase I/IIa trials: development plan, risk assessment, Go/No-Go decision criteria - Strategic considerations of early clinical trial designs - traditional vs. complex - Operational implementation of complex early phase protocols - The PEI perspective on early phase complex trials: Guard Rail Concept - study design, stopping rules and the decision making processDo you want to strategically plan your early phase clinical trials (phase I/IIa) from the start to accelerate drug development? Then get tips and hands-on experience regarding traditional and complex clinical studies in this online seminar!LernzieleA strategically well-planned drug development process offers a significant market advantage for pharmaceutical companies.- In this seminar, you will learn how to strategically align your early-phase studies (phase I/IIa) to maximise insights with minimal time investment. - What should you consider regarding the translation of preclinical experiences and dose selection? - How do regulatory authorities evaluate potential ideas and plans for combined study phases? - And how can the guidelines be practically implemented in terms of study protocol design, risk management, and safety monitoring?- Gain the necessary know-how and valuable hands-on experience in this seminar to efficiently align your drug development in traditional as well as complex early clinical trial phases.ZielgruppenThis seminar will be of benefit to all those working in the pharmaceutical industry who are responsible for the planning and conducting of early phase clinical trials (phase I/IIa) and who want to learn about: - the possibilities offered by combined study designs - key considerations in the strategic planning of complex study processes - regulatory perspectives on the evaluation of such complex study designs.- This course will be conducted in English.