NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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Postgraduate Programs
Yang Yue
A research fellow and doctoral supervisor with the School of Pharmacy of Tsinghua University, director of the Key Laboratory of the National Medical Products Administration, and dean of the Institute of Drug Regulation, School of Pharmacy, Tsinghua University. She is the first one to obtain a doctoral degree of pharmacy in pharmacy administration in China, who is mainly engaged in the researches of pharmaceutical regulations and drug policies and regulatory science. She is a member of the publicity and lecturing team of the NMPA for “Drug Administration Law”, “Vaccine Administration Law” and “Regulations on Supervision and Administration of Medical Devices”, whose representative works include “Research on Drug Regulatory Science of USA”, “Introduction to the Marketing Authorization Holder System” and the “21st Century Cures Act”.

【Research Projects】

[1] State Administration for Market Regulation, The International Experience in Drug Safety Supervision, May-December, 2019

[2] National Medical Products Administration, Research on Administrative Measures for Domestic Agents of Overseas Drug Marketing Authorization Holders, October - December, 2021.

[3] Bill and Melinda Gates Foundation, Regulatory Science Think Tank Construction of Vaccines and Other Medical Products, November 2019 - December 2021

[4] Beijing ADPAC International Consulting Co., Ltd., Policy Progress and Outlook of Pharmaceutical Intellectual Property Rights Protection in China, September - December, 2021

[5] China Society for Drug Regulation, Study on Reference of PDUFA Act for Capacity Improvement of Drug Regulators, October - November, 2021

[6] China Society for Drug Regulation, Study on the Revision of Prescription and OTC Drugs Classified Administrative Measures, September 2021 - August 2022

[7] Shanghai Johnson & Johnson Pharmaceutical Co., Ltd., Implementation Progress and Problems of the Marketing Authorization Holder System, November 2021 - May 2022

[8] Beijing Drug Administration, “Drug Safety Supervision in Beijing (2020)” and “Study on Drug Safety Risks and Countermeasures in Beijing”, September - December 2021

[9] China Center for Food and Drug International Exchange, Study on the Bench-marking Issues and Promotion Strategies for Chinese Drug Regulators’ Joining the PIC/S Inspection List, August 2021 - September 2022

[10] China Center for Food and Drug International Exchange, Study on the Concept and Methodology of the Design Guidelines of the ICH E20 Adaptive Clinical Tests, August 2021 - September 2022

[11] Drug Administration of Guangxi Zhuang Autonomous Region, Study on Medical Product Regulatory System of ASEAN Countries, November 2021 - December 2022

[12] Beijing ADPAC International Consulting Co., Ltd., Study on the Relationship between New Drug Definition and Related Systems under the Background of Pharmaceutical Power, December 2021 - April 2022

【Academic Achievements】

[1] Li Xiaoyu,Yang Yue. The drug lag issue: a 20-year review of China.[J]. Investigational new drugs, 2021,4,30,10.1007/s10637-021-01117-2 (IF= 3.850)

[2] Mao, X.,Yang, Y*.Gap analysis for chinese drug control institutes to achieve the standards of world health organization medicine prequalification. Journal of Pharmaceutical Sciences. 2017, 106(2): 652-659(IF 3.075)

[3] Aslam F, Yue Y*, Aziz M. Introduction of typhoid vaccine in the expanded immunization program of Pakistan. Hum Vaccin Immunother. 2021 Jul 3;17(7):2132. doi: 10.1080/21645515.2020.1869496. Epub 2021 Jan 31. PMID: 33522429; PMCID: PMC8189075.

[4] Aslam F, Khan FU, Yue Y. Rational Prescription and Cost-Effective Medication: Challenges and Opportunities in Pakistan. Innov Pharm. 2020 Oct 22;11(4):10.24926/iip.v11i4.1613. doi: 10.24926/iip.v11i4.1613. PMID: 34007642; PMCID: PMC8127104.

[5] Guo, T.,Yang Y., et al. Effects of midodrine in patients with ascites due to cirrhosis: systematic review and meta-analysis. Journal of Digestive Diseases. 2016, 17 (1) :11-19(SCI IF1.623)

【Enrollment Majors】 Biomedical engineering

【Contact Information】yanghappy@tsinghua.edu.cn

 

Post-doctors related with regulatory science are recruited all year round. Those with English proficiency will be preferred.