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40+ IVORY SOLUTIONS Interview Questions and Answers
Q1. what is the difference between product abuse and misuse
Product abuse is intentional misuse of a product, while product misuse is unintentional or accidental use of a product.
Product abuse is a deliberate act of using a product in a way that is not intended or recommended, often for recreational purposes or to achieve a high.
Product misuse, on the other hand, is the unintentional or accidental use of a product in a way that is not recommended or intended.
Examples of product abuse include using prescription drugs recreationally, us...read more
Q2. what is the difference between adverse event and reaction?
Adverse event refers to any undesirable medical occurrence, while reaction is a specific response to a drug or medical intervention.
Adverse event is a broader term that encompasses any negative medical occurrence, whether or not it is related to a drug or medical intervention.
Reaction specifically refers to a response to a drug or medical intervention.
Adverse events can include things like falls, infections, or other medical issues that may or may not be related to a drug or ...read more
Q3. What is the difference between Adverse drug event and Adverse drug reaction?
Adverse drug event refers to any untoward medical occurrence associated with the use of a drug, while adverse drug reaction specifically refers to a harmful reaction caused by a drug.
Adverse drug event is a broader term that encompasses any negative medical occurrence related to drug use.
Adverse drug reaction is a subset of adverse drug events and refers to a specific harmful reaction caused by a drug.
Adverse drug reactions are usually predictable and dose-dependent, while ad...read more
Q4. 1. Definition of day zero 2. GVP module VI 3. E2B 4. Classifiaction of antihypertensive drugs with MOA of the prototype drug 5. Criteria of a valid case 6.Seriousness criteria for a case
Questions related to drug safety and pharmacovigilance
Day zero is the start of a clinical trial or the day of drug administration
GVP module VI provides guidance on management of periodic safety update reports
E2B is the international standard for electronic transmission of individual case safety reports
Antihypertensive drugs are classified based on their mechanism of action, e.g. ACE inhibitors, beta blockers, calcium channel blockers
Valid case criteria include identifiable pa...read more
Q5. What is the difference between clinical research and pharmacovigilance.
Clinical research involves testing new drugs or treatments on humans, while pharmacovigilance involves monitoring the safety of drugs already on the market.
Clinical research is conducted during drug development to determine safety and efficacy.
Pharmacovigilance involves monitoring the safety of drugs already on the market and identifying adverse reactions.
Clinical research is typically conducted in a controlled environment, while pharmacovigilance relies on real-world data.
Cl...read more
Q6. what are the basic requirements in a case
The basic requirements in a case are essential elements or conditions that must be met for the case to proceed.
Clear and concise facts
Relevant evidence
Applicable laws and regulations
Proper documentation
Objective analysis
Logical reasoning
Effective communication
Timely resolution
Q7. What is MedDRA, Spontaneous case, literature case, signal detection, aggregate reporting, Causality, CDD, WHODD, DC/RC.
Explanation of various terms related to drug safety and pharmacovigilance.
MedDRA - Medical Dictionary for Regulatory Activities used for coding adverse events
Spontaneous case - Adverse event reported by healthcare professionals or patients directly to the regulatory authority
Literature case - Adverse event reported in scientific literature
Signal detection - Process of identifying potential safety issues from large volumes of data
Aggregate reporting - Summarizing safety data f...read more
Q8. What is Pharmacovigilance. What is MeDraw. Explain anything about Argus.
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance is important for ensuring the safety of drugs and protecting public health.
It involves monitoring and analyzing data from various sources, including clinical trials, spontaneous reports, and literature.
MeDraw is not a known term in pharmacovigilance.
Argus is a pharmacovigilance software deve...read more
Q9. -Classification of drugs (eg. Diabetic , hypertension and basic drugs)
Drugs can be classified into different categories based on their therapeutic use, such as diabetic, hypertension, and basic drugs.
Diabetic drugs are used to manage diabetes and regulate blood sugar levels, such as insulin and metformin.
Hypertension drugs are prescribed to control high blood pressure, like ACE inhibitors and beta-blockers.
Basic drugs refer to medications that are commonly used for various purposes, such as pain relievers like acetaminophen and ibuprofen.
Q10. what are the types of clinical trials
There are four types of clinical trials: Phase I, Phase II, Phase III, and Phase IV.
Phase I trials test the safety and dosage of a new drug on a small group of healthy volunteers.
Phase II trials test the effectiveness and side effects of a new drug on a larger group of patients with the targeted disease.
Phase III trials compare the new drug to the current standard treatment on a large group of patients to determine its safety and effectiveness.
Phase IV trials are conducted af...read more
Q11. what is pharmacovigilance
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 pharmaceutical products.
It aims to identify and assess adverse drug reactions (ADRs) and other drug-related issues.
Pharmacovigilance activities include collecting and analyzing data from healthcare professionals, patients, and regulatory autho...read more
Q12. Difference between Adverse event and adverse effect.
Adverse event is any undesirable experience associated with the use of a medical product. Adverse effect is a harmful and unintended reaction to a medical product.
Adverse event refers to any negative experience that occurs during the use of a medical product, regardless of whether it is related to the product or not.
Adverse effect refers specifically to a harmful and unintended reaction to a medical product.
Adverse events can include things like nausea, headache, or dizziness...read more
Q13. Define pharmacovigilance, how you code a case in database.
Pharmacovigilance is the science of monitoring, evaluating, and preventing adverse effects of drugs.
Pharmacovigilance involves collecting, analyzing, and reporting adverse drug reactions (ADRs)
Cases are coded in the database using standardized coding dictionaries such as MedDRA and WHO-DD
The coding process involves selecting the appropriate terms to describe the ADR and its severity
The coded data is used for signal detection, risk management, and regulatory reporting
Q14. Detailed explanation on Clinical trial and there Phases, ich guidelines and there purpose .
Clinical trials are research studies that test new treatments on humans. They are conducted in phases to ensure safety and efficacy.
Phase 1: Small group of healthy volunteers to test safety and dosage
Phase 2: Larger group of patients to test efficacy and side effects
Phase 3: Even larger group to confirm efficacy and monitor adverse reactions
ICH guidelines provide standards for designing, conducting, and reporting clinical trials
Purpose of clinical trials is to determine safet...read more
Q15. What is Adverse Drug Event?
Adverse Drug Event refers to any harmful or undesirable effect resulting from the use of a medication or drug.
Adverse Drug Events can range from mild to severe and can affect any part of the body.
They can occur due to various reasons such as incorrect dosage, drug interactions, allergic reactions, etc.
Examples of Adverse Drug Events include nausea, vomiting, dizziness, headache, allergic reactions, liver damage, etc.
Q16. What you know about ICH ?
ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ICH is a global organization that develops guidelines for the pharmaceutical industry.
It was formed in 1990 by regulatory authorities and the pharmaceutical industry.
ICH guidelines cover topics such as clinical trials, safety, quality, and efficacy.
The guidelines are not legally binding, but are widely adopted by regulatory authorities around the world.
Examples o...read more
Q17. What are the regulatory timeline s
Regulatory timelines refer to the timeframes set by regulatory agencies for the approval and monitoring of drugs and medical devices.
Regulatory timelines vary depending on the type of drug or device being reviewed and the regulatory agency involved.
For example, the FDA has different timelines for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Regulatory timelines can also be affected by factors such as the complexity of the drug or device, the avai...read more
Q18. What are the criteria for a valid case
Valid case criteria include identifiable patient, suspect drug, adverse event, and temporal relationship.
Identifiable patient information
Suspect drug information
Adverse event information
Temporal relationship between drug and event
Supporting medical documentation
Exclusion of alternative causes
Consistency with known drug effects
Reported by qualified reporter
Q19. Can you able to write the narrative
Yes, I am able to write the narrative.
I have experience in writing narratives for adverse events and serious adverse events.
I am familiar with the regulatory requirements for narrative writing.
I have strong attention to detail and can accurately capture all relevant information.
I am able to effectively communicate complex medical information in a clear and concise manner.
I am proficient in using various narrative writing tools and software.
Q20. Tell me about the processing?
Processing involves reviewing adverse event reports, coding and data entry, signal detection, and submission to regulatory agencies.
Reviewing adverse event reports for accuracy and completeness
Coding and data entry of adverse events into safety database
Performing signal detection to identify potential safety concerns
Preparing and submitting safety reports to regulatory agencies
Collaborating with cross-functional teams to ensure timely and accurate processing
Q21. What is Adverse Drug Reaction?
Adverse Drug Reaction is a harmful or unintended response to a medication.
It can range from mild to severe
It can occur immediately or after prolonged use
Examples include nausea, dizziness, and allergic reactions
ADR reporting is important for drug safety monitoring
Q22. Criterias for considering the case valid
Valid case criteria are important for drug safety analysis.
The case should have a clear indication of the drug being used.
The case should have a clear description of the adverse event.
The case should have a clear timeline of events.
The case should have sufficient medical information to support the adverse event.
The case should not have any confounding factors that could explain the adverse event.
The case should be reported within the appropriate timeframe.
The case should be c...read more
Q23. Definition of Pharmacovigilance.
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 and efficacy of drugs
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 pharmacovigilance activ...read more
Q24. How soon will you join. Are you able to work on exls ppts
I can join within two weeks. Yes, I am proficient in working on exls ppts.
I can join within two weeks.
I am proficient in working on exls ppts.
I have experience creating and editing PowerPoint presentations.
I am familiar with the features and functions of Excel PowerPoint.
I can effectively communicate information through PowerPoint slides.
Q25. What is Drug Misuse
Drug misuse refers to the inappropriate use of prescription or over-the-counter drugs, as well as illegal drugs.
Taking medication in higher doses than prescribed
Using someone else's prescription medication
Using illegal drugs
Mixing drugs with alcohol
Not following medication instructions
Using medication for non-medical purposes
Using medication for longer than prescribed
Using medication in a way other than intended
Using medication to get high
Using medication to cope with emotion...read more
Q26. What is pharmacovigilence?
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 and efficacy of drugs.
It includes collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.
Pharmacovigilance also involves communicating information about drug safety to healthcare professionals and the publi...read more
Q27. Definition of ADR and ADE
ADR stands for Adverse Drug Reaction, which refers to any harmful or unintended effect of a drug. ADE stands for Adverse Drug Event, which is a broader term that includes both expected and unexpected reactions to a drug.
ADR is a specific type of ADE
ADR can be caused by a drug's pharmacological properties, interactions with other drugs, or patient factors
ADEs can include medication errors, allergic reactions, and drug interactions
Both ADRs and ADEs are important to monitor and...read more
Q28. Difference between ADR and ADE
ADR refers to adverse drug reactions while ADE refers to adverse drug events.
ADR is a harmful or unpleasant reaction caused by a drug, while ADE is any untoward medical occurrence associated with the use of a drug.
ADR is a subset of ADE.
ADR is usually used to describe reactions that are known and expected, while ADE is a broader term that includes unexpected reactions.
Examples of ADRs include nausea, vomiting, and dizziness, while examples of ADEs include medication errors an...read more
Q29. How you code an event.
An event is coded using a standardized dictionary of terms called MedDRA.
MedDRA is a hierarchical dictionary with five levels of terms.
The event is coded to the most specific term available in MedDRA.
If the event is not listed in MedDRA, it can be coded as 'not otherwise specified' or 'unclassified'.
Q30. Common drug mechanism
Common drug mechanism involves targeting specific receptors or enzymes to alter physiological processes.
Drugs can target receptors to activate or inhibit them
Drugs can target enzymes to increase or decrease their activity
Examples include beta blockers targeting beta-adrenergic receptors and statins targeting HMG-CoA reductase
Drug mechanisms can also involve altering ion channels or transporters
Q31. What is MedDRA? it's current version?
MedDRA is a medical terminology used for coding and classifying adverse events and medication errors.
MedDRA stands for Medical Dictionary for Regulatory Activities.
It is a standardized dictionary used in pharmacovigilance to ensure consistent reporting and analysis of adverse events.
MedDRA is regularly updated to include new medical terms and improve coding accuracy.
The current version of MedDRA is version 24.1 (as of 2021).
Q32. Difference between AE and ADR
AE refers to any untoward medical occurrence in a patient, while ADR specifically refers to a harmful and unintended reaction to a medication.
AE can include symptoms, signs, diseases, or worsening of pre-existing conditions, while ADR is a subset of AE caused by a medication.
AE can be expected or unexpected, while ADR is always unexpected.
Examples of AEs include headache, nausea, or fever, while examples of ADRs include drug-induced liver injury or anaphylaxis.
Q33. Explain labelling
Labelling refers to the information provided on a product's packaging or container.
Labelling includes important information such as dosage instructions, warnings, and ingredients.
In the medical field, labelling is particularly important for ensuring patient safety and proper use of medications.
Examples of labelled products include prescription medications, over-the-counter drugs, and food packaging.
Labelling requirements may vary by country or region, and are often regulated ...read more
Q34. Main diffrence between AE and ADR.
AE stands for Adverse Event, which refers to any untoward medical occurrence in a patient. ADR stands for Adverse Drug Reaction, which specifically refers to a harmful reaction caused by a medication.
AE is a broader term that encompasses any negative medical event, while ADR specifically relates to medication-induced reactions.
AE can include events unrelated to medication, such as accidents or natural diseases, while ADR is directly caused by a drug.
AE can be expected or unex...read more
Q35. What is meant by half life of the drug?
Half life of a drug is the time it takes for the concentration of the drug in the body to be reduced by half.
Half life is a pharmacokinetic parameter used to determine the rate at which a drug is eliminated from the body.
It helps in determining the dosing frequency of a drug - drugs with longer half-lives may be dosed less frequently.
Half life is influenced by factors such as metabolism, excretion, and distribution of the drug in the body.
For example, the half life of aspirin...read more
Q36. How to manage peoples as a team
Managing a team involves effective communication, setting clear goals, providing support and feedback, fostering collaboration, and recognizing individual strengths.
Establish open and transparent communication channels
Set clear goals and expectations for the team
Provide support and guidance to team members
Encourage collaboration and teamwork
Recognize and utilize individual strengths and skills
Offer constructive feedback and address conflicts promptly
Promote a positive work en...read more
Q37. What is causality ?
Causality refers to the relationship between an event (the cause) and a second event (the effect), where the second event is a result of the first.
Causality is the concept of cause and effect.
It is used to determine if a drug or medical device caused an adverse event.
Causality assessment involves evaluating the temporal relationship, dose-response relationship, and alternative explanations for the event.
Causality can be difficult to establish in complex medical cases.
Examples...read more
Q38. What is AE and ADR?
AE stands for Adverse Event, which is any undesirable experience or effect associated with the use of a medical product. ADR stands for Adverse Drug Reaction, which is a type of AE caused by a medication.
AE refers to any negative experience or effect associated with the use of a medical product, regardless of whether it is caused by the product or not.
ADR specifically refers to negative experiences or effects caused by a medication.
Both AE and ADR are important to monitor and...read more
Q39. Difference between ADR and AE.
ADR is a harmful reaction caused by a drug, while AE is any untoward medical occurrence.
ADR is a known and expected harmful reaction caused by a drug.
AE is any untoward medical occurrence that may or may not be caused by a drug.
ADR is listed on the drug's label as a potential side effect.
AE can include symptoms, signs, diseases, or worsening of pre-existing conditions.
Example of ADR: nausea and vomiting from chemotherapy drugs.
Example of AE: headache or dizziness after taking...read more
Q40. Medra full form and use.
MedDRA stands for Medical Dictionary for Regulatory Activities. It is a standardized medical terminology used for coding adverse event information.
MedDRA is used for classifying and coding adverse events in clinical trials and post-marketing surveillance.
It helps in standardizing the terminology used for reporting adverse events in drug safety.
MedDRA is maintained and updated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Huma...read more
Q41. Defination of PV
PV stands for Pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
Pharmacovigilance involves monitoring and evaluating the safety of medications throughout their lifecycle.
It includes collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.
PV aims to improve patient safety by identifying and minimizing risks assoc...read more
Q42. Types of adverse drug reaction
Adverse drug reactions can be classified into six types.
Type A: Augmented pharmacological effects
Type B: Bizarre effects
Type C: Chronic effects
Type D: Delayed effects
Type E: End-of-treatment effects
Type F: Failure of therapy
Q43. 4 types
There are 4 types of drug interactions: pharmacokinetic, pharmacodynamic, combined toxicity, and additive effects.
Pharmacokinetic interactions affect the way a drug is absorbed, distributed, metabolized, or excreted.
Pharmacodynamic interactions occur when two drugs with similar or opposing effects are taken together.
Combined toxicity interactions happen when two drugs with toxic effects are taken together, resulting in a greater toxicity.
Additive effects occur when two drugs ...read more
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