Presented by
Management Forum
Navigating China’s API Regulations: An Essential Guide to DMF Registration Training Course
Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.
1 August 2023
+ 1 February 2024
from £150
- Format: Live online
- CPD: 1.5 hours for your records
- Certificate of completion
- EU Pharmaceutical Regulations & Strategy
- Pharmaceutical Regulatory Affairs in Africa
- Pharmaceutical Regulatory Affairs in Asia
- Pharmaceutical Regulatory Affairs in China
- Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
- Pharmaceutical Regulatory Affairs in the Middle East
- Navigating China’s API Regulations: An Essential Guide to DMF Registration
Overview
As China becomes an increasingly important market for pharmaceutical companies, compliance and safety are crucial.
This webinar has been designed to provide participants with a better understanding of the latest developments in China's Active Pharmaceutical Ingredients (APIs) regulations, including the new Drug Master File (DMF) registration routes that protect the confidentiality and interest of active drug substance suppliers.
Join our panel of industry experts as they discuss API registration in China and the quickest pathway options for DMF registration. Gain valuable insights into the related requirements and stay up-to-date with the dynamic and fast-changing regulations in China.
Don't miss this opportunity to enhance your knowledge of DMF, API, and China and learn from our industry leaders from this important region.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of Attending
- Gain in-depth knowledge and insights on how to register your Active Pharmaceutical Ingredient (API) in China
- Stay up-to-date on the latest API and DMF regulations and requirements for China
- Enhance your regulatory knowledge and skills for China and learn about the local requirements for Active Pharmaceutical Ingredient (API) registration
- Ensure compliance and safety by staying informed of the latest regulatory developments in China's API registration process
- Engage with industry experts and get your questions answered in real-time
- Gain competitive advantage by understanding the complexities of API registration in China and the quickest and most effective pathways for registration
Who Should Attend?
This webinar is designed for professionals who are involved in the pharmaceutical industry and need to understand the latest regulations on how to register APIs successfully in China. Targeted audience includes:
- Regulatory Affairs professionals who need to stay up-to-date with the latest regulatory developments in China's API registration process
- CMC Managers who need to ensure compliance and safety in the API registration process in China
- Quality Assurance Managers who need to understand the local requirements for API registration in China
- Project Management Professionals who are involved in the API registration process in China and need to ensure timely execution of the registration process
- Business Planning Professionals who need to understand the complexities of API registration in China for successful business planning
- Commercial Management Professionals who need to stay informed of the latest regulatory developments in China's API registration process for effective business management
The Navigating China’s API Regulations: An Essential Guide to DMF Registration course will cover:
Programme
Regulatory Framework
- Understand the regulatory landscape in China and the latest regulatory developments
China Regulatory Reform
- Hear the latest regulatory reforms in China that affect API registration
API Registration Pathways & Strategies in China
- Discover the quickest and most effective pathways for API registration in China
Procedures and Timelines
- Learn about the procedures and timelines involved in the API registration process in China
Dossier Requirements & Checklist
- Understand the dossier requirements and checklist necessary for API registration in China
API Registration Costs and Timelines
- Gain insights into the costs and timelines associated with API registration in China
Comparison of China DMF with EU & U.S
- Compare the Chinese DMF with the EU and U.S. DMFs to gain a better understanding of the differences and similarities
Technical Requirements - Pitfalls & Tips
- Learn about the common technical requirements, pitfalls, and tips for successful API registration in China
Q & A
- Engage with our panel of experts and get your questions answered in real-time
Raymond Ng
Accestra Consulting
Senior Regulatory Affairs Manager at Accestra Consulting
- Mr. Ng is based in China with almost a decade of regulatory affairs experience of the Chinese market with a Master’s Degree from the University of Nottingham.
- He has extensive knowledge of Chinese pharmaceutical regulatory requirements and has worked on numerous regulatory submissions with Chinese health authorities.
- Mr Ng has strong communication and practical experience dealing with the China NMPA (formerly CFDA) and CDE.
- A successful track record of supporting the top 50 pharma companies as well as biotech and medtech with market entry into China.
- To learn more about Raymond or Accestra Consulting, visit their website at www.accestra.com
Helen Ye
Accestra Consulting
RA & PV Director at Accestra Consulting
- Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
- She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customised solutions to international pharmaceutical companies and government institutions.
- She leads the registration team to plan, develop and implement compliance strategies for top pharma clients and has a successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and other products.
- Ms. Ye has a strong communication network with Chinese authorities (e.g. NMPA and CDE) and industry experts in China.
- To learn more about Helen or Accestra Consulting, please visit their website at www.accestra.com
Book Navigating China’s API Regulations: An Essential Guide to DMF Registration Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
1 August 2023
Live online
09:00-10:30 UK (London) (UTC+01)
10:00-11:30 Paris (UTC+02)
04:00-05:30 New York (UTC-04)
Course code 14114
- GBP 150 175
- EUR 220 255
- USD 250 289
Until 27 Jun
- 90 minutes of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
1 February 2024
Live online
09:00-10:30 UK (London) (UTC+00)
10:00-11:30 Paris (UTC+01)
04:00-05:30 New York (UTC-05)
Course code 14115
- GBP 150 175
- EUR 220 255
- USD 250 289
Until 28 Dec
- 90 minutes of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
