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HKAPI Regulatory Training Workshop Series – Seminar 4
三月 18, 2022 @ 3:00 下午 - 5:00 下午
HKAPI Regulatory Training Workshop Series- Seminar 4
Date: 18 March 2022 (Fri)
Time: 3:00 pm – 5:00 pm
RSVP: Please contact the HKAPI Office
Fee: To be confirmed
| Time | Topic | Speaker |
| 3:00 pm – 3:30 pm | ATP Regulatory Framework including New Product Registration & Clinical Trial Applications
|
Mr. Tony Chan
Pharmacist Drug Office 衞生署 |
| 3:30 pm – 4:00 pm | Researcher’s Perspectives of Conducting Clinical Trials on ATP | Prof Barbara Chan
Professor, Biomedical Engineering Programme Department of Mechanical Engineering Faculty of Engineering University of Hong Kong |
| 4:00 pm – 4:15 pm | Q&A | Kim Lee (Moderator)
Chief Scientific Officer at Novartis Pharmaceuticals (HK) Ltd / Member of HKAPI Regulatory Affairs Task Force |
| 4:15pm – 4:45pm | Real World Evidence and Regulatory Policy (US & EU): Utilization of Real World Evidence in Making Regulatory Decision
|
Ms. Susan Sandler
Pharmacist Global Regulatory Policy & Intelligence Johnson & Johnson UK (Ltd) |
| 4:45pm – 5:00 pm | Q&A | Ms. Susanna Yim (Moderator)
Associate Director Regulatory Affairs at Janssen Pharmaceutical Companies of Johnson & Johnson / Sub-team Lead of HKAPI Regulatory Affairs |
About the Speaker
Susan Sandler
Director, EMEA Policy Lead, in Global Regulatory Policy & Intelligence at Janssen R&D
Susan is a pharmacist with a regulatory affairs background in both blue chip pharma and regulatory affairs consultancy. She has broad-ranging expertise in EU regulatory policy/intelligence, regulatory product development/strategy, late phase/compassionate use, clinical trial operations across a range of product sectors. In her role, she engages in regulatory policy advocacy activities including representing Janssen R&D on external trade association activities and other organisations and contributing to the pharmaceutical commenting system. In particular, she staffs the EFPIA Integrated Evidence Generation and Use Working Group.
