Basic Information

• Programme type: Lecture with time for discussion or a practical workshop
• Primary target group: Bachelor's and Master's students and PhD students
• Also available for: Academic staff, if required
• Duration: 2 hours or by arrangement
• Capacity: No limit
• Language: Czech, English
• Date: By arrangement

Detailed Description

The lecture will introduce the practical operation of clinical trials of new medicinal products, covering the roles of the pharmaceutical company (Sponsor), Contract Research Organisation (CRO) and research site, the phases of clinical research and work with the study protocol, as well as the contractual, financial and regulatory aspects of conducting a clinical trial.

Particular emphasis will be placed on the Clinical Trial Agreement (CTA), its key provisions, payment terms, liability, data protection and the negotiation process between the CRO, sponsor and hospital. Students will also learn about the preparation and negotiation of clinical trial budgets, the principles of TCPP, Fair Market Value and Anti-Bribery and Anti-Corruption, as well as mechanisms for escalating budget requests to the sponsor.

Practical examples will demonstrate how effective contractual and budget negotiations can protect the hospital, principal investigator and study team and can significantly increase the funding available for conducting a clinical trial. The regulatory framework for clinical trials and the roles of EMA, FDA and SÚKL will also be briefly introduced. The lecture will include time for discussion and answering students' questions.

What Participants Will Learn

• How clinical trials of new medicinal products operate and the main phases of clinical development
• The roles of the Sponsor, CRO and research site and how they work together
• The key areas of a Clinical Trial Agreement (CTA) and how to identify terms that can be negotiated
• The principles of preparing and negotiating a clinical trial budget and escalating requests
• The importance of ICH-GCP, TCPP, Fair Market Value and Anti-Bribery and Anti-Corruption principles
• The importance of high-quality contractual and budget terms in protecting the hospital, Principal Investigator and study team
• The roles of EMA, FDA and SÚKL
• The role of regulatory authorities, including EMA, FDA and SÚKL, in the development and clinical evaluation of new medicinal products
• How to apply the knowledge gained through practical examples of contractual and budget negotiations

Contacts