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Regulatory Training Programme Course 3 (Drug Registration)

On March 27th, over 90 members showed up for the half-day training on the legal regulatory compliance of pharmaceutical business in Hong Kong.

In its third episode, they explored how to demonstrate efficacy, quality and safety in pharmaceutical registration, and understand the Good Submission Practice as well as the relevant legal and regulatory framework in effective medical communications to healthcare professionals and the public.

Clive Chan, Senior Pharmacist, Drug Registration and Import/Export Control Division, Drug Office, kickstarted the workshop, followed by his colleague Michael Yim who spoke on the Understanding of Undesirable Medical Advertisements Ordinance (UMAO).

Baker & Mckenzie Counsel Grace Wong and HKAPI Medical Director spoke on the medicinal advertisements, followed by a Q&A; session.

The latter half of the training includes a workshop where participants discuss how to prepare a good NCE application submission and how to review advertising materials through the use of case studies.

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