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プロフィール詳細
Hana A.に依頼
Malaysia
Regulatory affairs specialist with 8 years of experience in medical devices and pharma registration in ASEAN region.
プロフィール概要
専門分野
サービス
Writing
Technical Writing
Consulting
Scientific and Technical Consulting,
Regulatory Consulting
職務経験
Executive Regulatory Affairs
Astramern Sdn Bhd
5月 2020 - 現在
Executive Regulatory Affairs
AJ Research & Pharma Sdn Bhd
6月 2016 - 8月 2019
Regulatory Executive.
Boehringer Ingelheim
9月 2015 - 6月 2016
Executive Regulatory Affairs
Zuellig Pharma Ltd
11月 2013 - 8月 2015
学歴
BSc in Biotechnology
Malaysia University of Science and Technology (MUST)
9月 2010 - 9月 2013
認定資格
-
Awareness to Establishment on the Special Access and Conditional Approval
Medical Device Authority
8月 2021 - 現在
-
ISO 13485: 2016 Awareness Training
Permata Biru Health Consult Sdn Bhd
1月 2021 - 現在
-
ISO 13485 :2016 Internal Auditor Training
Permata Biru Health Consult Sdn Bhd
1月 2021 - 現在
-
Awareness on the Requirements of Good Distribution Practice of Medical Device (GDPMD)
Permata Biru Health Consult Sdn Bhd
9月 2020 - 現在
-
National Regulatory Conference 2018
National Pharmaceutical Regulatory Agency (NPRA)
10月 2018 - 現在
-
Seminar with Medical Device Industry 2018
Medical Device Authority
4月 2018 - 現在
-
MMDA Countdown to Full Implementation of Medical Device Act
Malaysia Medical Device Association
3月 2018 - 現在
-
Product Labelling and Hands on Training
International Food Safety Training Centre (IFSTC), Ministry Of Health Malaysia
9月 2017 - 現在
-
Halal Assurance Management System
Al Hamra Management Services PLT
8月 2016 - 現在
-
Training on Medical Device Regulation and Registration of IVD under Medical Device Act 2012
Medical Device Authority
6月 2014 - 現在
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