Professor Robert Makuch Meets with Chinese Government Officials and the Business Community to Discuss Regulatory Practices in China
Professor Robert Makuch, of the Yale School of Public Health, held several meetings at Yale Center Beijing on May 19th to discuss regulatory affairs science and practice in China. In the first meeting, regulatory-based data monitoring committees were discussed with several Chinese collaborators, as well as the implementation of the committees within the existing Chinese regulatory and pharmaceutical development environment.
The second meeting was held to discuss future training programs for senior members of the Chinese Food and Drug Administration (CFDA) with the CFDA Director. It was concluded that meetings would be held later this year in New Haven, CT and other training programs for CFDA members may be conducted at Yale Center Beijing. These future meetings are the result of ongoing training programs initiated in 2008 between Professor Makuch and the CFDA.
The third meeting focused on regulatory and practical issues surrounding 'blue-cap' registration.
For all meeting participants, a tour of the Center was provided and all remarked on the unique opportunities that the Center offers.
During his visit to China, Professor Makuch also gave a lecture on clinical drug development to members of Qilu Hospital at Shandong University in Jinan. He gave an overview of the life-cycle of drugs, from their discovery through post-approval studies and eventual termination in the marketplace. Professor Makuch's lecture was followed by a ceremony in which he was awarded a three-year Guest Professorship at Shandong University.