Understanding China’s Drug Approval Reforms: Executive Roundtable on Regulatory Changes

China’s regulatory landscape is evolving fast. In August 2015, the State Council issued an opinion on the Reform of the Drug Review and Approval System. Only a few months later in November 2015, the CFDA followed-up by releasing a Circular on Several Policies on Drug Registration Review and Approval.

The reforms seek to make the review system more efficient, clear the drug application backlog by the end of 2016, and foster the development of innovative drugs. One of the key reforms by the CFDA involves simplifying the approval process for clinical trials.

Join an exclusive group of 15 senior professionals and learn more about the impact recent reforms will have on the day-to-day operations of clinical research organizations and pharmaceutical companies in China.

This interactive roundtable discussion will be held over lunch (11:30 a.m. -2:00 p.m.) at the Shangri-La Pudong. Admission is free and limited to senior pharma and CRO industry professionals.

The speaker, David Lv, is an Associate at leading law firm Global Law Office. Prior to joining Global’s Shanghai Office, David had worked at the Shanghai Food and Drug Administration (FDA) for 11 years, where he focused on the regulation of medicine, medical devices, food, health food, cosmetics production, and enterprise operation.

Who should attend this event:

● Head of Operations
● Clinical Operations Director
● Head of Clinical Operations
● Head of Regulatory Affairs
● Clinical Study Manager
● Publication Manager

This executive roundtable is sponsored by Lionbridge, one of the world’s largest providers of translation and linguistic validation services for Pharmaceutical and Medical Device companies and CROs.