What’s Happening in China: An update on China’s regulatory development

Start Date & Time: 
Wednesday, 28 June, 2017 - 15:30
End Date & Time: 
Wednesday, 28 June, 2017 - 17:00
Venue: 

Amphitheatre, Duke-NUS Medical School, Level 2

Speaker: 
Speaker Details: 

Ms Vicky Han
Senior Director
Policy Group Lead for Asia Pacific
Global Regulatory Affairs
Janssen Asia Pacific

Speaker Details: 

Vicky Han, Senior Director, Group Lead for Regulatory Policy in Asia Pacific at Johnson & Johnson Pharmaceuticals, is currently in charge of Asia Pacific regulatory policy, in particular focusing on China and Japan, while engaging with external stakeholders for improving the regulatory environment.

Vicky has dedicated 18 years of her career to GSK with several positions in different countries: 12 years in GSK China for leading pharmaceuticals and vaccines regulatory affairs. She moved to GSK vaccines headquarters in Belgium in 2008, where she led a team responsible for worldwide cross-product regulatory affairs, and dealt directly with EMA for vaccines registration. In 2011, she relocated to GSK pharmaceuticals headquarters in London as the Senior Director & China expert in GRA, responsible for overseeing regulatory strategies in China. Vicky came back to Asia in February 2014, with a position heading Asia regulatory affairs in Hospira (a Pfizer company now) in Singapore for 2 years.

Vicky has extensive regulatory experiences throughout chemical & biological products, vaccines, Biosimilars and generics across different countries in Asia Pacific and Europe.

Synopsis: 

China is a dynamic market that has undergone tremendous changes over the past few decades. Following the State Council’s announcement of regulatory reform in August 2015, the Drug Administration Law and Drug Registration Regulations are currently at critical stages of revision. Many new regulations, guidelines and initiatives have been proposed to achieve this goal of regulatory reform, such as the Generic Consistency Evaluation campaign, which aims to improve the quality of generic products. 


CoRE welcomes you to join us for this complimentary seminar by Ms Vicky Han, who will describe some of these key changes and progress achieved to date in China. These efforts at regulatory reform are anticipated to positively impact the regulatory environment in China, improving patient access to new medicines and providing opportunities for companies doing business there. 

Host: 

A/Prof John Lim
Executive Director, CoRE, Duke- NUS
Deputy Director of Medical Services (Industry & Research Matters), Ministry of Health, Singapore 

Other Information: 

Event includes networking tea session (commencing at 3.30pm). Registration is complimentary.

Contact Person: