This is the main content of the Decree No. 131/2020/NĐ-CP of Vietnam’s Government providing for clinical pharmacology organization and activities in healthcare establishments, issued on November 02, 2020.
According to Decree No. 131/2020/NĐ-CP of Vietnam’s Government, apprenticeship served by clinical pharmacology supervisors is specified as follows:
- Content of apprenticeship served by clinical pharmacology supervisors:
+ Clinical pharmacology supervisors working at healthcare establishments must complete an apprenticeship in bioequivalence testing; clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center;
+ Clinical pharmacology supervisors working at traditional medicine establishments must complete an apprenticeship in clinical trial; clinical pharmacology and pharmacological research; or pharmacovigilance at a drug information and adverse drug reactions monitoring center for traditional drugs;
- Clinical pharmacology supervisors shall serve an apprenticeship of at least 2 years. Persons holding a doctoral degree or second level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 6 months. Persons holding a master’s degree or first level specialists in apprenticeship-related areas shall serve an apprenticeship of at least 12 months.
- Unless clinical pharmacology supervisors working at traditional medicine establishments, clinical pharmacology supervisors working at healthcare establishments shall serve their apprenticeships at one of the following facilities:
+ Providers of clinical trial services or bioequivalence study services; non-commercial bioequivalence testing facilities or clinical trial institutions;
+ Pharmacology or clinical pharmacology departments or centers of schools providing undergraduate medicine/pharmacy programs;
+ National or regional drug information and adverse drug reactions monitoring centers;
+ Healthcare establishments the clinical pharmacology units and activities of which are in compliance with regulations in this Decree or regulations of law taking effect before January 01, 2021.
View more details at the Decree No. 131/2020/NĐ-CP of Vietnam’s Government, effective from January 01, 2021.
Thuy Tram
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