Content
At the beginning of the seminar, the meaning and purpose of clinical trials will be explained. The role of clinical trials in the development and approval of new medical products and therapies as well as the ethical and legal aspects are discussed. The typical contents of an audit contract are covered and the legal framework and requirements that must be taken into account when drafting the contract are explained. Topics such as confidentiality, liability, intellectual property, data access and ownership, data protection and publications are discussed.
Furthermore, the roles and responsibilities of the parties involved, both the sponsor and the center, are highlighted. The various tasks and responsibilities are identified and the legal requirements are discussed to ensure that all parties meet their obligations.
Another focus of the seminar is on the financial agreements in clinical trials. The specifics of these agreements between the sponsor and the center are considered. Various models of remuneration and reimbursement for participation in clinical trials are presented and the legal requirements and best practices are discussed.
Topic overview
- Meaning and purpose of clinical trials
- Relevant legal basis and regulatory framework
- Typical contents of an inspection contract
- Roles and responsibilities
- Peculiarities of the financial agreement
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
