Grouphorse provided high-quality simultaneous interpreting services for the training program on multi-regional clinical trials (MRCTs) incorporating good clinical practice (GCP)-related considerations held in Peking University (PKU) from December 5 to 8. 

This event was hosted by the APEC-PKU HeSAY Regulatory Sciences Center of Excellence, and approved at the third APEC Senior Officials’ Meeting this August. It featured lectures and case studies on trends of clinical development for medical products, and MRCT-related matters, including its science basis and development strategy, Asian people-specific considerations, its design, statistical analysis and interpretation, adverse drug reaction reporting and risk management, GCP compliance investigation,  and ethical considerations.

△Group photo of the attendees

Attendees included Qin Xiaoling, deputy director of the Department of International Cooperation at China Food and Drug Administration (CFDA), and Prof. Zhan Qimin, director of the PKU Health Science Center, who delivered opening remarks, trainers such as He Li, vice chairperson of the Life Sciences Innovation Forum Regulatory Harmonization Steering Committee, Dr. Yoshiaki Uyama and Dr. Yoshimasa Yokoyama, directors of the International Conference on Harmonization (ICH) E17 team, representatives of the Pharmaceuticals and Medical Devices Agency, and other professionals from the CFDA, ICH E17 team, US National Institutes of Health, Duke University, R&D-based Pharmaceutical Association Committee and pharmaceutical companies, and 50 trainees with the regulatory bodies in APEC member economies.

△ Guests and lecturers

This program was the second one on MRCTs and GCP compliance investigation launched by APEC-PKU HeSAY Regulatory Sciences Center of Excellence, which brought to the regulatory bodies the most cutting-edge concepts, information and practices, while showcasing China’s strong regulatory capability and regulatory reform results over the past two years. The center has been serving as an important platform for international academic exchanges and contributing to the regulatory practices in China and the whole APEC region.

△ Case discussion

△Case discussion

△Case discussion

△Case discussion