Good Registration Practices and Best Practice Workshop (Day 1)
To facilitate good submission practices of the industry, the HKAPI Regulatory Working Group recently organized a 2-day workshop. Day 1 of the workshop was held on 24 November 2023 at Sassoon Road Campus of the University of Hong Kong, with over 90 participants.
Ms Sabrina Chan, Senior Executive Director of HKAPI, kick-started the event by welcoming speakers and all participants.
Mr Maxwell Yung, Pharmacist from the Drug Office, Department of Health, took the stage to provide a comprehensive overview of the New Chemical Entity (NCE) application guidelines and good submission practices. His presentation shed light on the crucial aspects that the industry needed to consider while preparing their submissions.
The event also featured an overseas speaker, Ms Pearle Liew, Head of Regulatory Affairs of AstraZeneca Singapore. Pearle shared an overview of therapeutic product registration in Singapore, as well as the considerations and challenges for various routes of review.
Following a short break, the workshop continued with interactive case study sessions. Participants were divided into ten groups, to discuss submission strategies and considerations under different conditions. This session enabled participants to exchange ideas and learn from one another’s experiences. Maxwell actively participated in the discussions and provided helpful advice to participants.
The workshop on 24 November drew to a close with closing remarks from Sabrina. She emphasized the importance of continued collaboration and knowledge sharing within the industry to foster a more efficient regulatory environment.
Thank you for all the support from speakers, working group members, facilitators and participants. We look forward to Day 2 of the workshop, which is scheduled for 5 December.