20 November 2018 (Tuesday) |
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08:30-09:30 |
Seminar Registration |
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09:30-09:45 |
Opening Address |
Dr Chan Hon-yee, Constance |
09:45-10:00 |
Photo Taking |
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10:00-10:30 |
Keynote Speech: GMP Harmonization & GMP Inspection Reliance from a PIC/S perspective |
Mr Meow Hoe Boon, PIC/S |
10:30-11:00 |
Tea Break |
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Regulation of Advanced Therapy Products (ATPs) |
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11:00-11:30 |
ATP regulation in Hong Kong: Journey So Far |
Mr Lot Chan, Drug Office |
11:30-12:00 |
Local & overseas GMP requirements for ATPs |
Ms Agnes Tse, Drug Office |
12:00-12:30 |
Q&A Session |
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12:30-14:00 |
Lunch |
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14:00-14:30 |
Bridging laboratory research to clinical applications: The critical stage of GMP production for advanced therapies |
Prof. Marc Turner, Consultant, Hong Kong Science & Technology Parks Corporation |
14:30-15:00 |
New technologies in biopharmaceutical manufacturing |
Mr Todd Waldron, Amgen Singapore Manufacturing |
15:00-15:20 |
Q&A Session |
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15:20-15:50 |
Tea Break |
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Experience from GMP Inspection |
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15:50-16:20 |
Experience on the regulation of drug manufacturing in Shanghai |
Mr Jianping Li, Shanghai Center for Drug Evaluation and Inspection |
16:20-16:50 |
FDA Drug Inspection Trends |
Dr Lane Christensen, US FDA |
16:50-17:10 |
Q&A Session |
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21 November 2018 (Wednesday) |
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PIC/S GMP |
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09:30-10:00 |
Implementation of PIC/S GMP: Challenges to Industry |
Dr Celine Cheng, Hong Kong Pharmaceutical Manufacturers Association |
10:00-10:30 |
Data integrity governance & implementation |
Mr Xuefei Lu, Bright Future Pharmaceutical Lab Ltd |
10:30-10:50 |
Q&A Session |
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10:50-11:20 |
Tea Break |
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11:20-11:50 |
Draft Revision of Annex 1 – Manufacture of Sterile Medicinal Products |
Mr Ashley Isbel, PharmOut |
11:50-12:20 |
GMP Inspection in Hong Kong & Version 14 of PIC/S GMP Guide |
Mr Raphael Yeung, Drug Office |
12:20-12:50 |
Q&A Session |
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12:50-13:00 |
Closing Remarks |
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