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PRODID:-//HKAPI - ECPv5.3.0//NONSGML v1.0//EN
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METHOD:PUBLISH
X-WR-CALNAME:HKAPI
X-ORIGINAL-URL:http://18.166.221.213
X-WR-CALDESC:Events for HKAPI
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TZID:Asia/Hong_Kong
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TZOFFSETFROM:+0800
TZOFFSETTO:+0800
TZNAME:HKT
DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;TZID=Asia/Hong_Kong:20220318T150000
DTEND;TZID=Asia/Hong_Kong:20220318T170000
DTSTAMP:20260413T175610
CREATED:20220208T082052Z
LAST-MODIFIED:20220301T084511Z
UID:11702-1647615600-1647622800@18.166.221.213
SUMMARY:HKAPI Regulatory Training Workshop Series - Seminar 4
DESCRIPTION:HKAPI Regulatory Training Workshop Series- Seminar 4\nDate: 18 March 2022 (Fri) \nTime: 3:00 pm – 5:00 pm \nRSVP: Please contact the HKAPI Office \nFee: To be confirmed \n\n\n\nTime\nTopic\nSpeaker\n\n\n3:00 pm – 3:30 pm\nATP Regulatory Framework including New Product Registration & Clinical Trial Applications \n \nMr. Tony Chan \nPharmacist \nDrug Office \nDepartment of Health\n\n\n3:30 pm – 4:00 pm\nResearcher’s Perspectives of Conducting Clinical Trials on ATP\nProf Barbara Chan \nProfessor\, \nBiomedical Engineering Programme \nDepartment of Mechanical Engineering \nFaculty of Engineering \nUniversity of Hong Kong\n\n\n4:00 pm – 4:15 pm\nQ&A\nKim Lee (Moderator) \nChief Scientific Officer at Novartis Pharmaceuticals (HK) Ltd / Member of HKAPI Regulatory Affairs Task Force\n\n\n4:15pm – 4:45pm\nReal World Evidence and Regulatory Policy (US & EU): Utilization of Real World Evidence in Making Regulatory Decision \n \nMs. Susan Sandler \nPharmacist \nGlobal Regulatory Policy & Intelligence \nJohnson & Johnson UK (Ltd)\n\n\n4:45pm – 5:00 pm\nQ&A\nMs. Susanna Yim (Moderator)  \nAssociate Director Regulatory Affairs at Janssen Pharmaceutical Companies of Johnson & Johnson / Sub-team Lead of HKAPI Regulatory Affairs\n\n\n\n\nAbout the Speaker \nSusan Sandler \nDirector\, EMEA Policy Lead\, in Global Regulatory Policy & Intelligence at Janssen R&D  \nSusan 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. \n  \n \n 
URL:http://18.166.221.213/event/hkapi-regulatory-training-workshop-series-seminar-4/
LOCATION:Virtual Meeting
CATEGORIES:Member's only,Regulatory
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