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New Product Submission and Best Practice Workshop

On December 18, 2019, around 70 members from the regulatory affairs and pharmacovigilance department attended the New Product Submission and Best Practice Workshop held at HKU.

The morning session began by a warm welcoming from Professor Ian Wong (Head of Department of Pharmacology and Pharmacy, The University of Hong Kong) and Ms. Sabrina Chan (Senior Executive Director, HKAPI). After that, Mr Michael Yim (Senior Pharmacist (Drug Registration), Drug Office, Department of Health) presented a brief overview of pharmaceutical registration guidelines and updates to our members. This was followed by an introduction into the regulation of ATP by Ms. Christine Cheung (Senior Pharmacist (Advanced Therapy Products Unit), Drug Office, Department of Health). Our members were more than glad to learn about the regulatory environment in Hong Kong from the honorary guests, and demonstrated active participation in the Q&A section.

After a short lunch break, our taskforce members provided a recap on good regulatory practice. Participants were then given case studies to understand the topic through discussion and interaction, followed by presentations of their ideas.

Workshop materials are available in the Member’s Area.

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