10+ ITFMS Infotech Interview Questions and Answers

Pharmacovigilance is essential in determining drug safety. It involves monitoring, assessing, and preventing adverse effects of drugs.

• Pharmacovigilance helps in identifying and reporting adverse drug reactions (ADRs) to regulatory authorities.

• It involves continuous monitoring of drugs even after they are approved and marketed.

• Pharmacovigilance data is used to update drug labels and inform healthcare professionals and patients about potential risks.

• It also helps in identifying...read more

Pharmacovigilance or Drug Safety involves monitoring, assessing, and preventing adverse effects of pharmaceutical products.

• Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• It involves monitoring and collecting data on the safety of drugs and medical devices after they have been approved and marketed.

• The goal is to ensure patient safety by identifying and mi...read more

Anticancer drugs include chemotherapy, targeted therapy, and immunotherapy. Antibiotic resistance is when bacteria become resistant to antibiotics.

• Chemotherapy drugs: cisplatin, doxorubicin, paclitaxel

• Targeted therapy drugs: imatinib, trastuzumab, rituximab

• Immunotherapy drugs: pembrolizumab, nivolumab, ipilimumab

• Antibiotic resistance is a growing problem due to overuse and misuse of antibiotics

• It occurs when bacteria evolve to become resistant to antibiotics, making infection...read more

Excipients are inactive substances added to drug formulations to improve stability, bioavailability, taste, appearance, etc.

• Excipients help in maintaining the physical and chemical properties of the drug.

• They can improve drug solubility, stability, and bioavailability.

• Excipients can also enhance the appearance, taste, and ease of administration of the drug.

• Examples of excipients include fillers, binders, disintegrants, lubricants, and coloring agents.

MedDRA is a medical terminology used for coding adverse events in clinical trials. ICH GCP is a guideline for conducting clinical trials.

• MedDRA stands for Medical Dictionary for Regulatory Activities

• It is used for coding and classifying adverse events in clinical trials

• ICH GCP stands for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice

• It is a guideline for conducting clinical trials ...read more

Health authorities are organizations responsible for regulating and overseeing healthcare practices within a specific region or country.

• Health authorities set guidelines and regulations for healthcare providers to ensure patient safety and quality of care.

• They monitor and investigate public health issues, outbreaks, and epidemics.

• Examples include the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and the World Health Or...read more

The name of the authority in India is the Central Drugs Standard Control Organization (CDSCO).

• Central Drugs Standard Control Organization (CDSCO) is the regulatory authority for pharmaceuticals and medical devices in India.

• CDSCO is responsible for approval of new drugs, clinical trials, import/export of drugs, and regulating the quality of drugs in the country.

Schedule P in pharmacy refers to the list of drugs and cosmetics that are not allowed to be sold without a prescription.

• Schedule P drugs are considered to have a high potential for abuse or addiction.

• These drugs are classified as prescription-only medications to ensure they are used safely and appropriately.

• Examples of Schedule P drugs include opioids, benzodiazepines, and certain stimulants.

• Pharmacies must adhere to strict regulations when dispensing Schedule P medications.

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring and evaluating the safety of drugs and medical devices after they have been approved for use.

• It includes collecting and analyzing data on adverse drug reactions and other drug-related problems.

• The goal of pharmacovigilance is to improve patient safety and minimize risks a...read more