The Impact of Final ICH GCP E6 R2 Guideline on Budgeting and Contracts in Globalization Environment: Changes Affecting Sponsors, CROs, Clinical Investigators, Sites

In this revised ICH GCP guideline on budgeting and contracts for clinical trial webinar will discuss the impact of changes in ICH GCP E6 R2 on investigator, site, sponsors CROs roles and responsibilities and the impact of clinical trial conducts and organizational practices along with evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.

Why Should You Attend:

Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development. In 2016, the ICH revised the E6 guidelines entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” to further standardize processes in biomedical products development, decrease redundancies; and reflect the current research landscape such as increases in globalization, study complexity, and technological capabilities.

In this webinar we will identify the changes impacting investigators, sites, Sponsors, CROs: responsibilities and roles and explain the impact of the revisions on clinical trials conduct and organizational practices. Also, during this webinar we will evaluate solutions/applicability/modifications of organizational SOPs, processes, procedures and staff training; and discuss opportunities for implementing the revised guideline.