In recent years, the number and type of activities related to clinical trials that are outsourced by the pharmaceutical industry have increased considerably.
It is therefore not surprising that in the ICH E6 (R2) the expectations of third-party supervision have been dealt with in more detail.
The addendum involves a series of changes in the contractual agreements and in the processes involving investigators, sponsors and CROs that will allow an effective management of quality risks, fundamental for the protection of human subjects and the reliability of the results of the studies.
ICH-GCP section 5.2.2 “the sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf.”
The 11th edition of Italian ePharma Day will therefore explore the multiple outsourcing models, the internal organizational model, the vendor selection methods (for example Contract Research Organizations (CRO), centralized laboratories and Clinical Trial Unit (CTUs)) and control of the activities carried out by the vendor himself (oversight).
The discussion will include aspects such as procedures, electronic tools to support and skills necessary to ensure efficient outsourcing in line with regulatory expectations, involving representatives of pharmaceutical companies, CROs, independent sponsors, as well as the regulatory authority.
The conference is aimed at all professionals working in the field of clinical research and drug development who belong to the following departments: