Drug safety has to monitor by collecting, detection, assessment with pharmaceutical products. Medication errors such as overdose, misuse and abuse of drugs or drug exposure can harm any patient. To prevent all these situations drug safety has been vital process. Below are few basic steps for drug safety.
- Data Collection & maintenance of global safety data
- Lab data, imaging data, EKG and QTC, safety review
- Medical coding of the cases
- Medical review of the cases
- Medical /QA review
- Safety medical monitoring of clinical trials
- Drug safety process
Below are few process to carried for drug safety:-
- SAE/AE Initial documentation and reporting.
- Case Report Characterization
- Epidemiologic Perspective for Marketed Product Reports
- SAE case processing