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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
China has opportunities to improve alignment with other countries’ more established regulatory systems, and the introduction of the DMF system is a major step towards alignment with global pharmaceutical regulatory standards. It has similarities with the US FDA procedure but there are subtle differences, which this program will examine in detail.
The 2-hour live broadcast will provide an overview and details of drug master files (DMF) for active pharmaceutical ingredients (APIs), excipients and packaging materials (or AEP) for China NMPA.
1 February 2022 – 7 March 2022: Early Bird $195 member | $230 nonmember
8 March 2022 – 7 April 2022: Regular $230 member | $270 nonmember
After this program, participants will:
By attending this program, regulatory professionals and overseas manufacturers will gain a thorough understanding of China DMF and better position themselves to meet the new requirements in China.
The agenda may vary based on changing requirements.
Guo Ning is an industry executive with degrees from Nankai University Tianjin (China) and University of Mannheim (Germany) who has developed a deep expertise in China market access issues via his experiences in industry, as a project manager at an import/export business, and as a technical compliance and product safety expert with Cisema for over 15 years.
Hamish King is COO at Cisema and is admitted as a lawyer in Hong Kong and in New South Wales, Australia and formerly with Magic Circle firm Linklaters in Hong Kong. He lives regularly writes and presents on China regulatory affairs life sciences topics.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to email@example.com. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email firstname.lastname@example.org with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance following the workshop.