Develop or market your drug in China more effectively with a deep understanding of the Chinese pharmaceutical regulatory landscape. In 2015 China’s pharmaceutical sector underwent significant regulatory reforms to align with EMA & FDA requirements, making the Chinese market one of the biggest pharmaceutical markets in the world. The reforms included clinical trial approval time being cut from 2 years to 60 days and the NMPA becoming a member of ICH.
During this course, you will learn fundamental Chinese regulatory requirements for pharmaceuticals and how they relate to the country’s economic and cultural background. Guided by our expert course leader you will discover best practices for registering new drugs and discuss the likely impact of the US-China Trade War on market access and drug development.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over 5 sessions students will learn through:
- Live interactive bitesize sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
The market landscape
Understand how China’s cultural and economic background has impacted pharmaceutical regulations
Learn about reforms to legislation in China and the reasons behind the changes, including the development of the NMPA and the move to the 60-day clinical trial approval time
Learn best practices for successfully registering pharmaceutical products in China and the challenges which coincide with it
Familiarise yourself with the regulations governing biopharmaceuticals in China, evaluate the trends and gain an overview of CMC guidance
US-China Trade War
Understand the potential impact of the US-China Trade War on the Chinese pharmaceutical market
Who is this course for?
This course is applicable to anyone interested in accessing the Chinese pharmaceutical marketplace.
Relevant job titles may include:
- Heads of Department
Relevant departments may include:
- Project Management
- Regulatory Affairs
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.