GCP Regulations and GCP Inspections

You will learn about the most important legal texts and guidelines in the GCP and IT sectors. You will recognize the 3 principles of legal compliance, safety and well-being of the trial subjects, and data integrity. The legal foundations of GCP inspections and the cooperation obligations of GCP stakeholders are presented by an experienced representative from the Federal Institute for Drugs and Medical Devices, BfArM. In particular, you will learn about documentation obligations with examples illustrating what can happen if they are not followed.

GCP Update

The latest briefing package on ICH E6 R3 is available.

GCP Implementation and GCP Updating, these learning objectives are at the center:

You should be able to navigate the EMA sources supporting the compliant conduct of clinical trials and acquire relevant information. You should understand that the EMA guidelines are intended as helpful references and examples for GCP-compliant conduct, not as rigid templates. Through examples, it should be clarified how observations contribute to the further development of the guidelines. Additional support can be found through existing standards (e.g., ISPE GAMP5) and illustrated with examples. You will be able to utilize approaches and procedures for data management (data flow, diagrams, data integrity) and validation (UAT) or testing evidence. The speaker team from industry and authorities will present the latest requirements and guidelines and also provide a good GCP update.