Atiqah Amran Email & Phone Number

Kuala Lumpur, My

Shah Alam, Selangor, Malaysia

- Responsible for managing the overall company Bioequivalence Study project- Managing the selection of a Clinical Research Organization (CRO) for BE study- Involve with monitoring of BE study (clinical part) and responsible for overseeing and managing appointed independent monitor- Performing sponsor feasibility audit on CRO- Reviewing essential BE study documents including study protocol, informed consent form, clinical report, Bioanalytical report, monitoring report- Prepare and compile BE report and biowaiver application for regulatory submission (new product and existing product)- Handling BE study correspondence from the regulatory authority (local & overseas)- Support the data entry and maintenance of the database related to pharmacovigilance- Preparing and maintaining risk registries for the BE study- Management and coordination of budget and expenses for BE study

Shah Alam, Selangor, Malaysia

- Responsible for coordinating all Bioequivalence (BE) study projects assigned (5-6 projects per year)- Managing the selection of a Clinical Research Organization (CRO) for BE study and appointed independent monitor- Reviewing essential BE study documents including study protocol, informed consent form, clinical report, Bioanalytical report, monitoring report- Prepare and compile BE report and biowaiver application for regulatory submission (new product and existing product)- Handling BE study correspondence from the regulatory authority (local & overseas)- Support the data entry and maintenance of the database related to pharmacovigilance

Shah Alam

- Coordinate and manage Bioequivalence (BE) study projects and ensure timely completion- Reviewing essential BE study documents including study protocol, informed consent form, clinical report, Bioanalytical report, monitoring report- Handling BE study correspondence from the regulatory authority- Compiling and reviewing technical dossier for regulatory submission- Taking charge of sourcing, purchasing, and managing market sample inventory for product development - Maintaining and updating the departmental database