The review team consists of a group of specialists in different scientific fields. Each member has different responsibilities.
-Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
-Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
-Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.
-Pharmacologist: Reviews preclinical studies.
-Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
-Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
-Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
-Project Manager: Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
-Medical Officer: Reviews all clinical study information and data before, during, and after the trial is complete.
-Statistician: Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.
-Pharmacologist: Reviews preclinical studies.
-Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
-Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc.
-Microbiologist: Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
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