Dan Tran Email & Phone Number

Hanoi, Vn

Hanoi, Vn

Vietnam

Vietnam

- Responsible for registration of general medical devices and IVDs in Vietnam.- Manage product changes/regulation updates impacting on registration in Vietnam.- Support business and distributor in tender.- Be a power user of Regulatory Information Management system in South East Asia.- Be co-editor of PARAphrase (Quarterly newsletter for Public Affairs and Regulatory Affairs updates) in Greater Asia region.- Support registration of medical devices in Thailand.

Vietnam

At regulatory affairs assistant position, I am responsible for preparing and submitting registration dossiers for in vitro diagnostic medical device (IVD). I also followed and updated product changes affecting registration in Vietnam. In addition, I support distribution partners and sales in preparing tend dossiers and get import permits as well as RA related tasks.

Vietnam

- Research toxicity and pharmacological effects of traditional medicine products to prepare preclinical records for drug registration.- Develop protocol and implement clinical surveys of traditional medicine products. Identify potential products for clinical trials to prepare clinical records for drug registration. Indications: migraine, cerebral circulation insufficiency, osteoarthritis, menopause, chronic urticaria, erectile dysfunction, premature ejaculation, chronic bronchitis, irritable bowel syndrome, liver diseases.- Develop pharmacovigilance SOP, supervise and handle adverse events.- Develop products training materials for marketing and sale departments.