D. C. BHOOTA, TAX CONSULTANTS Interview Questions and Answers

Clinical trials are research studies that test new treatments or interventions on humans to determine their safety and efficacy.

• Clinical trials are conducted in phases, each with a specific purpose and goal.

• Phase 1 trials involve a small group of healthy volunteers to test safety and dosage.

• Phase 2 trials involve a larger group of patients to test efficacy and side effects.

• Phase 3 trials involve an even larger group of patients to confirm efficacy and monitor adverse reaction...read more

Good clinical practice in Pharmacovigilance involves systematic monitoring, evaluation, and reporting of adverse drug reactions.

• Adherence to regulatory guidelines and protocols

• Timely and accurate reporting of adverse events

• Continuous monitoring of drug safety profile

• Risk management and mitigation strategies

• Collaboration with healthcare professionals and regulatory authorities

• Ensuring patient confidentiality and privacy

• Proper documentation and record-keeping

• Regular training an...read more

ICH and CGP guidelines are regulatory guidelines for drug development and clinical trials.

• ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines provide a framework for the development, registration, and post-approval of pharmaceutical products.

• CGP (Good Clinical Practice) guidelines provide a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials....read more

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

• It includes collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems

• Pharmacovigilance helps to identify new safety concerns and prevent harm to patients

• Examples of pharmacovigilanc...read more

ADR stands for Adverse Drug Reaction and ADE stands for Adverse Drug Event.

• ADR refers to any harmful or unintended reaction to a medication, including side effects and allergic reactions.

• ADE is a broader term that encompasses any negative event related to medication use, including errors in prescribing, administering, or monitoring.

• Both ADR and ADE are important considerations in drug safety and pharmacovigilance.

• Examples of ADRs include nausea, dizziness, and rash, while exa...read more

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 the safety of medications post-market approval.

• It includes collecting, analyzing, and reporting adverse drug reactions.

• Pharmacovigilance aims to improve patient safety and minimize risks associated with medications.

• Regulatory agencies like the FDA and EMA require pharmace...read more

Shift timings are typically fixed and adherence to shifts is crucial for maintaining workflow and ensuring coverage.

• Shift timings are usually predetermined and communicated to employees in advance.

• Adherence to shifts is important for maintaining productivity and ensuring all tasks are completed on time.

• Failure to adhere to shifts can result in disruptions to workflow and potential gaps in coverage.

• Examples of shift timings could include day shifts (9am-5pm), evening shifts (1...read more

Anticancer drugs are medications used to treat cancer by inhibiting the growth of cancer cells.

• Anticancer drugs can be classified based on their mechanism of action, such as alkylating agents, antimetabolites, and targeted therapies.

• Examples of anticancer drugs include cisplatin, methotrexate, and trastuzumab.

• These drugs may be used alone or in combination with other treatments like surgery, radiation therapy, or immunotherapy.