BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//HKAPI - ECPv6.18.3//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:HKAPI
X-ORIGINAL-URL:https://hkapi.hk
X-WR-CALDESC:Events for HKAPI
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:Asia/Hong_Kong
BEGIN:STANDARD
TZOFFSETFROM:+0800
TZOFFSETTO:+0800
TZNAME:HKT
DTSTART:20210101T000000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=Asia/Hong_Kong:20220304T140000
DTEND;TZID=Asia/Hong_Kong:20220304T163000
DTSTAMP:20220302T023921Z
CREATED:20220208T081321Z
LAST-MODIFIED:20220302T023921Z
UID:11697-1646402400-1646411400@hkapi.hk
SUMMARY:HKAPI Regulatory Training Workshop Series - Seminar 2
DESCRIPTION:HKAPI Regulatory Training Workshop Series- Seminar 2\nDate: 4 March 2022 (Fri) \nTime: 2:00 pm – 4:30 pm \nRSVP: Please contact the HKAPI Office \nFee: To be confirmed \n\n\n\nTime\nTopic\nSpeaker\n\n\n2:00 pm – 2:30 pm\nNew Drug Registration in Hong Kong \nRegulations\, updated guidance and review practice \n \nMr. Maxwell Yung \nPharmacist \nDrug Office \nDepartment of Health\n\n\n2:30 pm – 3:00 pm\nLatest Trends on New Drug Registration _ Reliance Pathways and its Applications \n \nMs. Mary Flannery \nHead Regulatory Affairs Bayer Pharma ANZ \nAPAC Regulatory Policy Network Lead \nBayer\n\n\n3:00 pm – 3:25 pm\nPanel Discussion: \nWhat is the learning from Global Trend and is it applicable to Hong Kong?\nMr. Tony Chow (Moderator) \nHead of Regulatory Affairs at Bayer / Sub-team Lead of HKAPI Regulatory Affairs\n\n\n3:25 pm – 3:30 pm\nBreak\n \n\n\n3:30 pm – 4:30 pm\nWorkshop on New Drug Application \nTips and examples to enhance your submission skill\nEducation Sub-team of HKAPI Regulatory Affairs\n\n\n\n\nAbout the Speaker  \nMary Flannery \nHead Regulatory Affairs Bayer Pharma ANZ\, APAC Regulatory Policy Network Lead\, Bayer \nMary is a graduate of the Royal Society of Chemistry (1989) and subsequently completed an MSc (Biochemistry) in 1996. She began working in Regulatory Affairs in 1994 following a foundation 5 year period in R&D and laboratory environments.  Over the last 20 years\, Mary has held leadership roles in Regulatory Affairs and Regulatory & Reimbursement functions within the innovative pharmaceutical sector in Australia/New Zealand. As a career industry participant\, Mary’s key interest is in the global harmonisation of development requirements combined with efficient and predictable regulatory environments. Both elements are crucial to improving timely access to new medicines for patients across the globe. \n Mary’s current role is Head\, Regulatory Affairs for Bayer Pharma ANZ and APAC Lead for the APAC RA Policy network. \n \n 
URL:https://hkapi.hk/event/hkapi-regulatory-training-workshop-series-seminar-2/
LOCATION:Virtual Meeting
CATEGORIES:Member's only,Regulatory
ATTACH;FMTTYPE=image/jpeg:https://hkapi.hk/wp-content/uploads/2022/02/Blue-and-Red-72x36-Landscape-Voter-Education-Campaign-Banner-1-min-scaled.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Asia/Hong_Kong:20220311T140000
DTEND;TZID=Asia/Hong_Kong:20220311T163000
DTSTAMP:20220301T084343Z
CREATED:20220208T081801Z
LAST-MODIFIED:20220301T084343Z
UID:11700-1647007200-1647016200@hkapi.hk
SUMMARY:HKAPI Regulatory Training Workshop Series - Seminar 3
DESCRIPTION:HKAPI Regulatory Training Workshop Series- Seminar 3\nDate: 11 March 2022 (Fri) \nTime: 2:00 pm – 4:30 pm \nRSVP: Please contact the HKAPI Office \nFee: To be confirmed \n\nContent\n\n\n\nTime\nTopic\nSpeaker\n\n\n2:00 pm – 2:20 pm\nGlobal Trend of e-labeling: and case sharing \nDr. Sara Ellmark  \nExecutive Regulatory Science Director \nAstrazeneca\n\n\n2:20 pm – 2:30pm\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\n2:30 pm – 3:05 pm\nUpdates on CORP Registration\nMr. Albert Chung \nPharmacist \nDrug Office \nDepartment of Health\n\n\n3:05 pm – 3:20 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\n3:20 pm – 3:25 pm\nBreak\n \n\n\n3:25 pm – 4:30 pm\nWorkshop on CORP Registration: \nExercises to enhance submission standard and learn from best practice\nEducation Sub-team of HKAPI Regulatory Affairs \n\n\n\n  \n\nAbout the Speaker \nDr. Sara ELLMARK \nExecutive Regulatory Science Director\, AstraZeneca Sweden \nPhD\, Molecular Biology\, Gothenburg University\, Sweden \nSara has 15+ years’ experience in pharmaceutical development in various roles across medical communications\, regulatory affairs and global labelling. \nHer current role is Executive Regulatory Science Director in AstraZeneca\, and previously she led AstraZeneca’s Global Labelling Group. Sara has also been actively engaged in e-labelling related activities\, both within AstraZeneca and as an active member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) ePI working group\, as well as the Inter-Association Task Force (IATF) for e-labelling.
URL:https://hkapi.hk/event/hkapi-regulatory-training-workshop-series-seminar-3/
LOCATION:Virtual Meeting
CATEGORIES:Member's only,Regulatory
ATTACH;FMTTYPE=image/jpeg:https://hkapi.hk/wp-content/uploads/2022/02/Blue-and-Red-72x36-Landscape-Voter-Education-Campaign-Banner-1-min-scaled.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Asia/Hong_Kong:20220318T150000
DTEND;TZID=Asia/Hong_Kong:20220318T170000
DTSTAMP:20220301T084511Z
CREATED:20220208T082052Z
LAST-MODIFIED:20220301T084511Z
UID:11702-1647615600-1647622800@hkapi.hk
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:https://hkapi.hk/event/hkapi-regulatory-training-workshop-series-seminar-4/
LOCATION:Virtual Meeting
CATEGORIES:Member's only,Regulatory
ATTACH;FMTTYPE=image/jpeg:https://hkapi.hk/wp-content/uploads/2022/02/Blue-and-Red-72x36-Landscape-Voter-Education-Campaign-Banner-1-min-scaled.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Asia/Hong_Kong:20220325T140000
DTEND;TZID=Asia/Hong_Kong:20220325T163000
DTSTAMP:20220321T015849Z
CREATED:20220208T082430Z
LAST-MODIFIED:20220321T015849Z
UID:11705-1648216800-1648225800@hkapi.hk
SUMMARY:HKAPI Regulatory Training Workshop Series - Seminar 5 Medical Devices & Private Healthcare Facilities Ordinance
DESCRIPTION:Medical Devices & Private Healthcare Facilities Ordinance Medical Device\nDate: 25 March 2022 (Fri) \nTime: 2:00 pm – 4:30 pm \nFee: To be confirmed \nRSVP: Please contact the HKAPI Office \n\n\n\nTime\nTopic\nSpeaker\n\n\n2:00 pm – 2:45 pm\nRegulatory Framework of Medical Devices: \n·        Pre-market and post-market control \n·        Requirement of listing \n·        How will Medical Device Division process listing application of Drug – Device Combination Product & Companion Diagnostic IVDMD\nMr. Yorkie Chow \nSenior Electronics Engineer (Medical Device) 1 \nMedical Device Division \nDepartment of Health \nMr. Alex Choi \nSenior Electronics Engineer (Medical Device) 2 \nMedical Device Division \nDepartment of Health\n\n\n2:45 pm – 3:30 pm\nPrivate Healthcare Facilities Ordinance (PHFO): \nScope of the regulations and its applications\nDr. Mark Lee \nMedical & Health Officer – Advisory Committee \nOffice for Regulation of Private Healthcare Facilities \nDepartment of Health\n\n\n3:30 pm – 4:00 pm\nImplications of PHFO to Healthcare Professional & Drug and Medical Device Industry\nMs. Marcia Lee \nSpecial Counsel \nBaker McKenzie\n\n\n4:00 pm – 4:30 pm\nPanel Discussion\nMs Linda Chan (Moderator) \nRegulatory Affairs Lead at Bristol Myers Squibb / Sub-team Lead of HKAPI Regulatory Affairs\n\n\n\n 
URL:https://hkapi.hk/event/hkapi-regulatory-training-workshop-series-seminar-5/
LOCATION:Virtual Meeting
CATEGORIES:Member's only,Regulatory
ATTACH;FMTTYPE=image/jpeg:https://hkapi.hk/wp-content/uploads/2022/02/Blue-and-Red-72x36-Landscape-Voter-Education-Campaign-Banner-1-min-scaled.jpg
END:VEVENT
END:VCALENDAR