For the novice research professional, the clinical research field can seem both daunting and confusing. This TRIUM Training provides the high-level knowledge required for a proper understanding of the research related rules, responsibilities, interactions and jargon used. An introduction to research history and definitions, ethics, guidelines (ICH GCP – ISO14155) and regulations, clinical research in pharma, biotech and medical devices, trial roles and responsibilities will be provided in an interactive fashion. Room for discussion and sharing of experiences is foreseen.
Please register via this link: firstname.lastname@example.org
- + FREE Webinar for all at.las members
- + Not an at.las member yet but interested to become one? This webinar is for free as well if you join!
- + €100 for non at.las members
By the end of this TRIUM Training you should be able to:
- Define clinical trials
- Describe the therapy development process
- List the most important guidelines and regulations on a global scale for clinical trials
- List the various research stakeholders and how they interact
- Explain the main sponsor, investigator and ethics committee responsibilities as per ICH GCP (R2) and ISO14155
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.