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HKAPI Regulatory Training Workshop Series – Seminar 2
March 4, 2022 @ 2:00 pm - 4:30 pm
HKAPI Regulatory Training Workshop Series- Seminar 2
Date: 4 March 2022 (Fri)
Time: 2:00 pm – 4:30 pm
RSVP: Please contact the HKAPI Office
Fee: To be confirmed
|2:00 pm – 2:30 pm||New Drug Registration in Hong Kong
Regulations, updated guidance and review practice
|Mr. Maxwell Yung
Department of Health
|2:30 pm – 3:00 pm||Latest Trends on New Drug Registration _ Reliance Pathways and its Applications
|Ms. Mary Flannery
Head Regulatory Affairs Bayer Pharma ANZ
APAC Regulatory Policy Network Lead
|3:00 pm – 3:25 pm||Panel Discussion:
What is the learning from Global Trend and is it applicable to Hong Kong?
|Mr. Tony Chow (Moderator)
Head of Regulatory Affairs at Bayer / Sub-team Lead of HKAPI Regulatory Affairs
|3:25 pm – 3:30 pm||Break|
|3:30 pm – 4:30 pm||Workshop on New Drug Application
Tips and examples to enhance your submission skill
|Education Sub-team of HKAPI Regulatory Affairs|
About the Speaker
Head Regulatory Affairs Bayer Pharma ANZ, APAC Regulatory Policy Network Lead, Bayer
Mary is a graduate of the Royal Society of Chemistry (1989) and subsequently completed an MSc (Biochemistry) in 1996. She began working in Regulatory Affairs in 1994 following a foundation 5 year period in R&D and laboratory environments. Over the last 20 years, Mary has held leadership roles in Regulatory Affairs and Regulatory & Reimbursement functions within the innovative pharmaceutical sector in Australia/New Zealand. As a career industry participant, Mary’s key interest is in the global harmonisation of development requirements combined with efficient and predictable regulatory environments. Both elements are crucial to improving timely access to new medicines for patients across the globe.
Mary’s current role is Head, Regulatory Affairs for Bayer Pharma ANZ and APAC Lead for the APAC RA Policy network.