With the challenges in recruitment and placing more global studies in developing countries, regulatory agencies have raised concerns over ethical and data quality standards. Cultural diversity, variability in ethical review, difficulty in recruiting investigators with GCP experience and different regulatory standards in non ICH countries constitute major challenges to pharmaceutical industries and marketing authorization agencies related to compliance with GCP and ethical standards. This symposium covers local laws, specific customs within developing regions such as Asia, Africa, and South America and examples of effective methods for dealing with and managing the trial requirements, managing risks and providing solutions for developing local partners and cooperative efforts with foreign regulators and IRBs.

Learning Objectives:
Discuss the challenges and trends in GCP compliance outside ICH GCP regions
Identify regulatory, ethics and trial management strategies to ensure an effective clinical trial outcome.