19 September - 15.00-16.00 BST / 10.00-11.00 ET

This webinar is about China Drug Master Filing (DMF) comparing with EU and U.S DMF. The presentation provides an overview of the DMF regulatory systems covering Active Pharmaceutical ingredients (API), Excipients & Packaging Materials.

Thanks to the global harmonization efforts, the Chinese DMF regulatory system is becoming more similar with US DMF, EU ASMF, CEP and Japanese DMF requirements. However, local requirements and gaps in the regulations still exists, and it is important to understand these to minimize risks and issues with China CDE & NMPA.

Presenters

April Wang, Regulatory Affairs Manager at Accestra Consulting (April.wang@accestra.com)

• Ms. Wang is a senior regulatory affairs consultant supporting pharmaceutical companies with understanding Chinese regulatory requirements.
• She has in-depth understanding on Chinese Pharmaceutical regulations and accumulated extensive hands-on experience with DMF filing & drug registration projects during daily work.
• Ms. Wang has strong communication network with Chinese authorities including NMPA and CDE.
• A successful track record with supporting international pharma with market entry into China including big and small pharma.

Raymond Ng, Business Development Director at Accestra Consulting

• Mr. Ng is based in China with almost a decade of regulatory affairs experience for 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 Health Authorities.
• Mr. Ng has strong communication and practical experience dealing with the Chinese health authorities including NMPA (formerly CFDA) and CDE.
• A successful track record of supporting top 50 pharma companies as well as biotech and medtech with market entry into China.

Ms. Marylene Zhan, Regulatory Affairs Manager at Accestra Consulting

• Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs with a Master's Degree from the Zhongnan University of Economics and Law.
• Marylene is a seasoned bilingual and bicultural consultant who specializes in China regulatory compliance and pharmacovigilance services (RA/PV).
• She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements.
• Marylene has a rich experience in serving international pharma companies with market entry into China and is known for her excellent communication skills and ability to build strong relationships with clients.
• She is committed to providing high-quality services that meet her clients' needs and helping them achieve their business objectives in the Chinese market.

Company Introduction

This webinar is sponsored by  Accestra Consulting

Accestra Consulting (www.accestra.com) is a professional China Regulatory Affairs Outsourcing agent to support pharmaceutical companies with drug & medical device registration with China NMPA (Formerly CFDA) including services related to China Drug Master File (DMF) for APIs, Excipients & Packaging Materials, Pharmaceutical Drug registration, pharmacovigilance and others. For info email: info@accestra.com

Disclaimer: Whilst TOPRA is running this webinar for Accestra, this is not an endorsement of Accestra, Accestra's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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