PS
Uploaded byPristyn Research Solutions
8,320 views

PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 2022..pdf

The document serves as a comprehensive guide for job seekers in pharmacovigilance, outlining key concepts, definitions, objectives, and roles within the field. It also discusses important regulations, methodologies for signal detection, reporting timelines for adverse events, and the significance of pharmacovigilance in drug safety and efficacy. Additionally, it highlights essential resources and organizations relevant to pharmacovigilance practices in India and globally.

Embed presentation

Downloaded 61 times
PHARMACOVIGILANCE Updated IN 2022: COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS By Pristyn Research A quick Job interview short guide For Pharma and all Life science jobseekers. info.pristynresearch.com www.pristynresearch.com 9028839789 | 8999717656 All Medical | Biotech |Micro |B.Sc., M.Sc.
For PV Job Interview with Answers questions 01. Different terms used in PV 02. DEFINITIONS 03. What are the contents? PAN India PV companies list alphabetically. Companies List
Prepared BY C.E.O & FOUNDER Pristyn Research Solutions AZHER KHAN Scientific writer, Pristyn Research Solutions MRINAL R. GITE
According to W.H.O-C.C.I.D.M The science and activities related to the detection, assessment, understanding, prevention & Reporting of adverse effects or any other drug-related problem. What is Pharmacovigilance (PV)? To collect evidence - medicine-related problems. • To build Public confidence • Identification of risk factors • Quantifying risks • Understanding the concepts of ADR, Medical Errors, Public Health Significance, Regulatory Interventions, ADR Monitoring schemes. What are the objectives of PV?
• Rapid identification of events that are likely to affect adherence to treatment and determination of their rates, and identification of the risk factors that make these events more likely, to reduce their occurrence; • Identification of signals (i.e., possible causal relationships between an adverse event and a medicine; see Glossary) of ADRs of concern following the introduction of a new drug or drug combination; • Assessment of signals to evaluate causality, clinical relevance, frequency and distribution of ADRs in particular population groups; calculation of rates of events so that: a) Risk can be measured; b) The safety of different medicines can be compared and informed choices made; c) Risk factors can be identified; • Contribution to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit; Aim of PV
• Appropriate response or action in terms of drug registration, drug use and/or training and education for health professionals and the public; • Measurement and evaluation of the outcome of the response or action taken (e.g. reduction in risk, improved medicine use, or improved outcome for patients experiencing a particular ADR); • Timely communication with and recommendations to authorities and the public; • Feedback to the clinicians who provided the information …..Continue…..
What is Goal of PV? To ensure the benefits of the use of medicine. safeguard the health of the Indian population. International Society of PV (ISOP) This is an important international society. Their website gives information about meetings and training courses. What is MedDRA? MedDRA (Medical Dictionary for Regulatory Activities) is a standardised medical terminology, published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and PV databases, and to facilitate searches in these databases.
Manage and relay drug safety information Maintain current knowledge of global drug safety regulations Participate in the training of operational staff on drug safety issues Summarise clinical safety data, participate in meetings with potential and actual study sponsors Write narratives with medical input from a physician Quality control work of other staff in the department Take on any other task as assigned by the manager or within the capabilities of the Drug Safety Associate. Report SADRs to the Regulatory Authorities WHAT ARE THE Role of Drug Safety Associate ?
1 2 3 Death/Life-threatening Events: 7 days Other Serious Events: 15 days Non-serious Events: 90 days What are the due dates for safety reporting? Various manufacturers have set their timelines to avoid any late cases. Timelines change from one drug to another and also on basis of causality and seriousness
What are the types of PV? Two types. 1. Active PV and 2. Passive PV
Which are different Databases used in PV? 1 BaseCon – Safety Base Interchange 3 Ennov Group 5 Clinevo Safety 7 VigiBase 2 4 6 8 Oracle - Argus Safety Database AB Cube – Safety Easy Aris Global - ARISg/ Life Sphere Safety PvNET Beneficial effects? What should a narrative consist of? A narrative should consist of precise and concise information about the source of the report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner. The adverse effect of a drug should not be considered without into the account its beneficial effects.
State the benefits of PV program This program will increase the knowledge and importance of Pharmacovigilance in the drug discovery process and Clinical Research, Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety & efficacy of drug results into new job avenues. The participants after the completion of this would have new economic pursuits as Pharmacovigilance potential opportunities & growth prospects are huge. Pharmacovigilance Programme of India (PVPI) - launched in July 2010. What are Data assessments in PV? 1 2 Aggregated assessment and interpretation 3 4 5 6
WHAT PRODUCTS DOES PV COVER Medicines Herbal products Biologicals Blood Products Vaccines Traditional & supplementary products Cosmetics Veterinary & Tobacco vigilance Medical devices Which products are covered by PV?
Methods of signal detection? Clinical assessment of individual events Clinical review of collated events Record linkage Automated signal detection. There are four methods for identifying signals
Why PV is required after clinical trial?
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. What is an Adverse Drug Event (ADE)? What is the minimum criterion required for a valid case according to WHO? a. An identifiable reporter b. An identifiable patient c. A suspect product d. An adverse drug event When do you consider an event to be serious? If an event is associated with any one of the following, it is considered to be serious Death Life-threatening Congenital anomaly Disability Medically significant
What do you mean by causality? Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event. • Is there a convincing relationship between the drug and the event? • Did the drug actually cause the event? Name some data elements in ICSR Age Gender Race A Drug odse & dosage form Therapy date & Duration Indication B Event onset date Seriousness criterion Event end date and latency. C Dechallenge Rechallenge Action taken D Summary of the report Medicicnes Sugestions E PATIENT DEMOGRAPHICS SUSPECT PRODUCT DETAILS ADVERSE EVENT DETAILS CAUSALITY NARRATIVE WRITING
What are types of reports?
Types of Unsolicited reports Sources of Solicited Reports ✓ Direct reports (consumers, healthcare professionals, other) ✓ Medical information enquiries ✓ Literature – via literature searching of medical and scientific journals ✓ Lay literature (press/media) – non- medical/scientific literature ✓ Internet/digital media (website, internet forum, chat room, blog, social network) ✓ Clinical trials ✓ Non-interventional studies ✓ Registries ✓ Post-approval named patient programmes ✓ Patient support programmes (PSPs) ✓ Surveys of patients/HCPs
Reporter details Date and place of the report.
Name the core regulatory bodies India: IDA Indian Drug Administration previously known as Central Drugs Standard Control Organization (CDSCO) CDSCO Australia: Therapeutic Goods Administration TGA USA: United States Food and drug administration USFDA UK: Medicines and Healthcare Products Regulatory Agency MHRA Europe: European Medicines Agency EMA Canada- Health Canada HC China - National Medical Products Administration (NMPA) NMPA Japan: Ministry of Health, Labour and Welfare MHLW
What is Volume 9A? Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorization Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonization (ICH). Part I deals with Guidelines for Marketing Authorization Holders; Part II deals with Guidelines for Competent Authorities and the Agency; Part III provides the Guidelines for the electronic exchange of Pharmacovigilance in the EU. Part IV provides Guidelines on Pharmacovigilance communication. Volume 9A is presented in four parts:
What do you know about E2a, E2b and E2c guidelines? E2a: E2a guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. E2b: E2b guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports. E2c: E2c guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.
EudraVigilance The data-processing network and management system of the European Union, set up by the EMA to facilitate the electronic exchange, management and scientific assessment of individual case safety reports on all medicinal products approved in the European Economic Area (EEA). It also incorporates data analysis facilities. Medwatch is the FDA’s safety information and adverse event reporting form. It was founded in 1993 and is used for volunteer reporting an adverse event. Patients may be more susceptible to particular ADRs if they also have other health problems, either because of the concomitant condition or from the interaction of the medicines being used to treat the other condition(s). Medwatch Co-morbid conditions Define the terms Given below
When do you consider a case to be medically confirmed? A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional). Note: HCP can be a physician, nurse, pharmacist, coroner or psychologist. What is CemFlow? CemFlow is a tool maintained by the UMC for database management in cohort event monitoring (CEM). It is web-based and the fields match the data elements on the questionnaires. There are screens for patient demographics, treatment initiation, treatment review and assessment of events. CemFlow is a tool for data entry into an online database maintained by the UMC (Uppsala Monitoring Centre) for CEM. CemFlow provides for entry of cohort data as well as the events.
Pregnancy Overdose (>MTD) Off label use, Medication error Lack of efficacy Used for Unapproved Indication Misuse Special case scenarios in PV
The Yellow Card Scheme is the UK system for collecting information on the suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. In 1964, the Scheme was founded after the thalidomide disaster and was developed by Bill Inman. What is the yellow card in PV? What is the blue card in PV? Blue card form is used to report suspected adverse reactions to vaccines and prescription, over-the-counter and complementary medicines in Australia. What are Co-morbid conditions? Patients may be more susceptible to particular ADRs if they also have other health problems, either because of the concomitant condition or from the interaction of the medicines being used to treat the other condition(s).
NR not resolved RS resolved with sequelae R2 resolving R1 resolved A Outcomes of the event Suitable methods of reporting Telephone E-mail Fax B Internet Moderate Mild Not severe C Seriousness criteria based on intensity Severe Probable Possible Certain D Likely Synonyms for causality- related Synonyms for causality- Unrelated Un-assessable Unclassified Unlikely E
What is medication error? Missuse The situations where the medicine is intentionally and inappropriately used as per the authorised PI or the directions for use on the medicine label. • Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug. Examples of medication errors include misreading or miswriting a prescription. Medication errors that are stopped before harm can occur are sometimes called “near misses” or “close calls” or more formally, a potential adverse drug event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while others are caught before harm can occur (“near- misses”). • Medication errors are more common than adverse drug events, but result in harm less than 1% of the time. About 25% of adverse drug events are due to medication errors.
The point at which a drug is again given to a patient after its previous withdrawal. Re-challenge The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed. De-challenge What is a signal? Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action.
What is Day Zero? Day zero remain the day that the first information was received. Or Day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available. The WHO Drug Dictionary (DD), MedDRA and the WHO Adverse reactions terminology (WHO-ART). WHODD= used for drug coding MedDRA, WHO-ART = coding of events. What is WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR? USAR: An unexpected adverse reaction (UAR) is an adverse reaction that is not consistent with the product information in the SPC. A suspected unexpected serious adverse reaction (SUSAR) is any UAR that at any dose ✓ Results in death ✓ Is life-threatening (i.e. the subject was at risk of death at the time of the event) ✓ Refer to an event that hypothetically might have caused death if it were more severed ✓ Requires hospitalisation or prolongation of existing hospitalisation ✓ Results in persistent or significant disability or incapacity ✓ Is a congenital anomaly or birth defect. ✓ The development of SUSAR is uncommon (unexpected issue) observed during a clinical trial and for which there is a relationship with the experimental drug, whatever the tested drug or its comparator.
Definitions 02. Terms You Should Know Before Applying For PV
Absolute risk Risk in a population of exposed persons; the probability of an event affecting members of a particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence) or at a given time (prevalence). Adverse Event (AE) Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Adverse Drug Reaction (ADR) A response that is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or modifies the physiological function of the body. (WHO, 1972). “A response to a medicinal product which is noxious and unintended.”
Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur during the use of medicines, for intensified follow-up of selected medicinal products phase. Patients are monitored from the time they begin treatment, and for a defined period of time.
Association Events are associated with time but not necessarily linked as cause and effect. Cem-Flow Software developed by UMC for collection and analysis of data in Cohort Event Monitoring. Biological products Medical products prepared from biological material of human, animal or microbiologic Compliance Faithful adherence by the patient to the prescriber’s instructions. De-challenge The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed.
Attributable risk
Data mining A general term for computerised extraction of potentially interesting patterns from large data sets is often based on statistical algorithms. A related term with essentially the same meaning is ‘pattern discovery’. In pharmacovigilance, the commonest application of data mining is so called disproportionality analysis, for example using the Information component (IC). Disproportionality analysis Screening of ICSR databases for reporting rates which are higher than expected. For drug- ADR pairs, common measures of disproportionality are the Proportional Reporting Ratio (PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for drug-drug-ADR triplets, such as Omega (Ω). Critical terms Some of the terms in WHO-ART are marked as ‘Critical Terms’. These terms either refer to or might be indicative of serious disease states, and warrant special attention, because of their possible association with the risk of serious illness which may lead to more decisive action than reports on other terms
Effectiveness/risk The balance between the rates of effectiveness of medicine versus the risk of harm is a quantitative assessment of the merit of medicine used in routine clinical practice. Comparative information between therapies is most useful. This is more useful than the efficacy and hazard predictions from pre- marketing information that is limited and based on selected subjects. Efficacy The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard). Harm The nature and extent of actual damage that could be caused by a drug. Not to be confused with risk.
Epidemiology It is the science concerned with the study of the factors determining and influencing the frequency and distribution of disease, injury and other health-related events and their causes in a defined human population to establish programs to prevent and control their development and spread. Essential medicines Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Excipients All materials included in making a pharmaceutical formulation (e.g. a tablet) except the active drug substance(s).
Formulary A listing of medicinal drugs with their uses, methods of administration, available dose, dosage forms, side effects, etc, sometimes including their formulas and methods of preparation. Frequency of ADRs In giving an estimate of the frequency of ADRs the following standard categories are recommended: ❖ Very common* > 10% ❖ Common (frequent) >1% and <10% ❖ Uncommon (infrequent) >0.1% and < 1% ❖ Rare >0.01% and <0.1%Very rare* <0.01%
Generic (multisource product) The term ‘generic product’ has somewhat different meanings in different jurisdictions. Generic products may be marketed either under the non- proprietary approved name or under a new brand (proprietary) name. They are usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after the expiry of the patent or other exclusivity rights. Herbal medicine Includes herbs, herbal materials, herbal preparations and finished herbal products.
Homoeopathy Homoeopathy is a therapeutic system that works on the principle of ‘like treats like’. An illness is treated with a medicine that could produce similar symptoms in a healthy person. The active ingredients are given in the highly diluted form to avoid toxicity. Homoeopathic remedies are virtually 100% safe. Incidence A number of new cases of an outcome that develop over a defined period in a defined population at risk. Information component (IC) The Information component (IC) measures the disproportionality in reporting a drug- ADR pair in an ICSR database relative to the expected reporting based on the drug's overall reporting and the ADR. Positive IC values indicate higher reporting than expected. The IC has also been implemented on electronic health records to detect interesting temporal relationships between drug prescriptions and medical events.
Individual Case Safety Report (ICSR) A report that contains ‘information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient’. MedDRA MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO Adverse Reactions Terminology, is now mapped to MedDRA. Medical error “An unintended act (either of omission or commission) or one that does not achieve its intended outcomes.”
Member countries Countries that comply with the criteria for, and have joined the WHO Programme for International Drug Monitoring. Odds and odds ratio Probability of an occurrence p divided by the probability of its non-occurrence (1 - p). The Ratio of the Odds in a given population and the Odds in another population. National Pharmacovigilance centres Organisations recognised by governments to represent their country in the WHO Programme (usually the drug regulatory agency). A single, governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety.
Omega (Ω) A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to highlight potential signals of drug-drug interactions. Just like the more established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of reports. A positive Ω indicates higher reporting than expected. Medicinal product available to the public without a prescription. OTC (Over the Counter) medicine PaniFlow Software developed by UMC for collection and analysis of data concerned with vaccinations in a pandemic situation.
A systematic review of the global safety data became available to the manufacturer of a marketed drug during a specific time period. Produced in an internationally agreed format. Periodic Safety Update Report (PSUR) Pharmacoepidemiology Study of the use and effects of drugs in large populations.
Pharmacology Phocomelia Phytotherapy Placebo Poly-pharmacy
Post-marketing The stage when a drug is generally available on the market. Predisposing factors Any aspect of the patient’s history (other than the drug) which might explain reported adverse events (genetic factors, diet, alcohol consumption, disease history, polypharmacy or use of herbal medicines, for example). Prescription Only Medicine (POM) Medicinal products are available to the public only on prescription.
Prescription Event Monitoring (PEM) The system created to monitor adverse drug events in a population. Prescribers are requested to report all events, regardless of whether they are suspected adverse events, for identified patients receiving a specified drug. Also more accurately named Cohort Event Monitoring. Prevalence A number of existing cases of an outcome in a defined population at a given point in time. Rational drug use An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best understanding of their appropriateness for the indication and the particular patient, and their benefit, harm effectiveness and risk.
Prophylaxis Prevention or protection. Record linkage Method of assembling information contained in two or more records, e.g. In different sets of medical charts, and vital records such as birth and death certificates. This makes it possible to relate significant health events that are remote from one another in time and place. An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best understanding of their appropriateness for the indication and the particular patient, and their benefit, harm effectiveness and risk. Rational drug use Reference risk Risk in a population of unexposed persons; also called baseline risk. Reference risk can be measured over time (incidence) or at a given time (prevalence). The unexposed population refers to a reference population, as closely comparable to the exposed population as possible, apart from the exposure.
Relative risk Ratio of the risk in an exposed population (absolute risk) and the risk in an unexposed population (reference risk). Relative risk is the result of relative comparison between outcome frequency measurements, e.g. incidences. The probability of harm being caused; the probability (chance, odds) of an occurrence. Risk Regulatory authority The legal authority in any country with the responsibility of regulating all matters relating to drugs. Any unintended effect of a pharmaceutical product occurring at a normal dosage is related to the pharmacological properties of the drug. Side effect
Serious Adverse Event or Reaction A serious adverse event or reaction is any untoward medical occurrence that at any dose: ❖ results in death; ❖ requires inpatient hospitalization or prolongation of existing hospitalization; ❖ results in persistent or significant disability/incapacity; ❖ is life-threatening. Triage It is the process of placing a potential adverse event report as a serious/ non- serious case, valid case/ duplicate case/No case, and prioritizing case reporting.
ADR Reporting process in PV
Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action. Signal Summary of Product Characteristics (SPC) A regulatory document is attached to the marketing authorization forms the basis of the product information made available to prescribers and patients. Spontaneous reporting A System whereby case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority.
Thalidomide Drug was prescribed in the 1950s as a mild sleeping pill and remedy for morning sickness for pregnant women. This led to serious birth defects and the start of modern pharmacovigilance. Returning to favour in the treatment of serious diseases such as cancer and leprosy. Unexpected adverse reaction An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug. Traditional medicines Traditional medicine is the total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
VigiMed Share point-based conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring for fast communication of topical pharmacovigilance issues. A statistical tool within Vigi-Search with vast statistical material calculated for all Drug- ADR pairs (combinations) available in Vigi-Base. The main features include the disproportionality measure (IC value) stratified in different ways and useful filter capabilities. VigiMine VigiFlow Vigi-Flow is a complete ICSR management system created and maintained by the UMC. It is web-based and built to adhere to the ICH-E2B standard. It can be used as the national database for countries in the WHO Programme as it incorporates tools for report analysis and facilitates sending reports to Vigi-Base.
VigiBase The name of the WHO Global ICSR Database. VigiSearch A search service for accessing ICSRs stored in the Vigi-Base database offered by the UMC to national pharmacovigilance centres and other third-party inquirers. WHO-ART Terminology for coding clinical information concerning drug therapy. WHO-ART is maintained by UMC. WHO Drug Dictionary (WHO DD) The WHO Drug Dictionary is an international classification of drugs providing proprietary and non-proprietary names of medicinal products used in different countries, together with all active ingredients.
Explain the hierarchy in MedDRA. ❖ System Organ Class (SOC) ❖ High Level Group Term (HLGT) ❖ High Level Term (HLT) ❖ Preferred Term (PT) ❖ Lower Level Term (LLT) What is MedDRA used for? Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4
Companies list 03. PAN India PV companies list alphabetically
ABBOTTS COGNIZANT I 3 GLOBAL DRUG SAFETY LAURUS LABS PARAXEL SRISTEK ACCENTURE CREST. I GATE PATNI COMPUTERS MAHINDRA SATYAMBSG PIRAMAL SUN PHARMA ALEMBIC DIAGNOSEAR CH ICON MAKROCARE PPD SYMOGEN APC PHARMA. DR REDDY’S iMEDGlobal, MANKIND QUANTUM SOLUTIONS SYNOGEN APCER ECRON ACUNOVA IMS HEALTH MEDHIMALAYAS QUINTILES TAKE SOLUTIONS APCER EMCURE INC RESEARCH MEDPACE. SCIFORMIX RATIOPHARM TCS ASTRAZENECA FDC Infocorp Soft Solutions MICRO LABS RX MD THOMSON REUTERS AUROBINDO FORTIS HEALTH CARE INVENTIVE MSD (MERCK) SANTHA BIOTECH USV LIMITED BESTOCHEM G7 INFOTECH IPCA LABORATORIES NEKTAR THERAPEUTICS SCIFORMIX. VIMTA LABS BIOCAD GENPACT IPLEX NORWICH CLINICAL SERVICES SHANTHA BIOTECHNICS WIPRO BIOCON GRANULES JUBILIANT-BIOSYS NOVARTIS SIRO CLINPHARM WNS BIOLOGICAL E. LTD GVK KINAPSE NOVO NORDISK SP softtech WOCKHARD T BLUEFISH HCL LAMBDA OMNICARECLINICA L RESEARCH SRI KRISHNA PHARMA 4C Pharma Solutions
Important For free Simple Guidance |Support| Mentorship on jobs & business in India, Watch this short video recorded by the government college https://www.youtube.com/watch?v=UfB2fvTBM3w&t=659s
For Job Oriented Regular / Weekend /Online Certified Industrial Training | Internship & Short Term Courses with placements assistance and guarantee. Kindly call us @ +91-9028839789. Mumbai Pune Aurangabad Kolhapur Kerala Online/Offline in the below cities of India. Pharmacovigilance | Clinical Research | Clinical Data Management. Drug Regulatory Affairs | Pharma Q.A / Q.C |Pharma Production. Pharma Digital Marketing | R & D |Medical Coding. Medical Transcription | Medical Writing |Research Publications. Course In Course In Course In Course In
Candidate calls | Counselling by Pistyn experts on Career! Enrollment to placement procedures campus to corporate! Candidate enrolls online / Offline via Pristyn System! Training / Course starts with the regular oral assessment! Industrial Internship + Practical field starts! Placement & certification!
Training & Placement activities
Thank You

More Related Content

PDF
Pharmacovigilance Study Material (Download).pdf
byKokilaMurugasan
 
PPTX
Pharmacovigilance
byJABEEN FATIMA
 
PDF
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEW AND ITS PREPARATION
byPristyn Research Solutions
 
PDF
Pharmacovigilance Basics for fresher's as well as experience candidates
byJonaid Ali
 
PDF
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS
byPristyn Research Solutions
 
PPTX
Pharmacovigilance regulations as per European Union
byBindu Kshtriya
 
PPTX
Pharmacovigilanve And Its Importance
byshubham sinha
 
PPTX
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCE
byRamakrishna K
 
Pharmacovigilance Study Material (Download).pdf
byKokilaMurugasan
 
Pharmacovigilance
byJABEEN FATIMA
 
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEW AND ITS PREPARATION
byPristyn Research Solutions
 
Pharmacovigilance Basics for fresher's as well as experience candidates
byJonaid Ali
 
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS
byPristyn Research Solutions
 
Pharmacovigilance regulations as per European Union
byBindu Kshtriya
 
Pharmacovigilanve And Its Importance
byshubham sinha
 
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCE
byRamakrishna K
 

What's hot

PPTX
PSUR
byShitalDesale1
 
PPTX
Periodic Safety Update Report (PSUR)
byDr. Rohith K Nair
 
PPTX
Establishment of Pharmacovigilance Programme
byNipun Gupta
 
PPTX
Pharmacovigilance signal and signal detection
byKiranRajput38
 
PPTX
Post marketing surveillance
byDr. Vijesha Soni
 
PPTX
Severity, seriousness, predictability and preventability assessment
byDr. Ramesh Bhandari
 
PPTX
ICH E2A GUIDELINE
bysathishat9
 
PDF
Post Marketing Drug Safety & Pharmacovigilance
byMd. Zakaria Faruki
 
PPTX
MedDRA
byDr. Ashish singh Parihar
 
PPTX
Adverse Drug Reaction (ADR) Pharmacovigilance
bykashi institute of pharmacy
 
PPTX
Pharmacovigilance
byDr. Vishal Pawar
 
PPTX
Contract Research Organisations- CRO in Pharma Field
byVINOTH R
 
PDF
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
byLászló Árvai
 
PPT
Medical Dictionary for Regulatory Activities (MedDRA)
bySMS MEDICAL COLLEGE
 
PDF
Pharmacovigilance methods
byDr. Ramesh Bhandari
 
PPTX
Regulatory authority of japan
byAadityaThole
 
PDF
Good Clinical Practice and Pharmacovigilance
byMd. Zakaria Faruki
 
PPTX
Spontenous adr reporting
bySONALPANDE5
 
PDF
Safety Reports: PBRER / PSUR
byAzierta
 
PPTX
Vaccine pharmacovigilance _ rajiv ahlawat
byRajiv Ahlawat | NIPER | Mohali
 
PSUR
byShitalDesale1
 
Periodic Safety Update Report (PSUR)
byDr. Rohith K Nair
 
Establishment of Pharmacovigilance Programme
byNipun Gupta
 
Pharmacovigilance signal and signal detection
byKiranRajput38
 
Post marketing surveillance
byDr. Vijesha Soni
 
Severity, seriousness, predictability and preventability assessment
byDr. Ramesh Bhandari
 
ICH E2A GUIDELINE
bysathishat9
 
Post Marketing Drug Safety & Pharmacovigilance
byMd. Zakaria Faruki
 
MedDRA
byDr. Ashish singh Parihar
 
Adverse Drug Reaction (ADR) Pharmacovigilance
bykashi institute of pharmacy
 
Pharmacovigilance
byDr. Vishal Pawar
 
Contract Research Organisations- CRO in Pharma Field
byVINOTH R
 
General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appel...
byLászló Árvai
 
Medical Dictionary for Regulatory Activities (MedDRA)
bySMS MEDICAL COLLEGE
 
Pharmacovigilance methods
byDr. Ramesh Bhandari
 
Regulatory authority of japan
byAadityaThole
 
Good Clinical Practice and Pharmacovigilance
byMd. Zakaria Faruki
 
Spontenous adr reporting
bySONALPANDE5
 
Safety Reports: PBRER / PSUR
byAzierta
 
Vaccine pharmacovigilance _ rajiv ahlawat
byRajiv Ahlawat | NIPER | Mohali
 

Similar to PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 2022..pdf

PDF
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONS
byJonaid Ali
 
PPTX
Pharmacovigilance
byMANISH MOHAN M
 
PPTX
PHARMACOVIGILANCE-introduction metod .pptx
bysubhanalla39
 
PPTX
Pharmacovigilance and adr
byNilesh Siddhawar
 
PPT
GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Gl...
byUntil ROI
 
PPTX
Pharmacovigilance system-updated 2025.pptx
byAlaa Fadhel Hassan Alwazni
 
PDF
pharmacovigilance pdf (1)
byPrasad Bhat
 
PDF
Pharmacovigilance pdf (1)
byPrasad Bhat
 
PDF
Pharmacovigilance and Materiovigilance.pdf
byDr. Yuppie Rajasekhar Poonuru
 
PPTX
Pharmacovigilance AND HIPAA
byPrajal M. Christian
 
PPTX
Pharmacovigilance Overview
bySivasankaranV
 
PDF
Advancing Pharmacovigilance: Safeguarding Drug Safety and Enhancing Public He...
byMedwin Publishers
 
PPTX
Pharmacovigilance
byPriyesh Pandya
 
PPTX
basic information resource.pptx
bySiddharthShekharSing4
 
PPTX
History n progress of pv
byRamavath Aruna
 
PPTX
Pharmacovigilance-an overview
byDr. Pramod Kumar
 
PDF
PHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
byVenugopal N
 
PPTX
Pharmacovigilance_ Dr Ruchi Kushwaha.pptx
byDr Ruchi Kushwaha
 
PPTX
establishing_pv_centers_in_industry_AND_NATIONAL_PROGRAMME[1].pptx
byashharnomani
 
PPTX
PHARMACOVIGILANCE ( PVPI)BY DR SURYA K.pptx
bySurya Ganesh
 
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONS
byJonaid Ali
 
Pharmacovigilance
byMANISH MOHAN M
 
PHARMACOVIGILANCE-introduction metod .pptx
bysubhanalla39
 
Pharmacovigilance and adr
byNilesh Siddhawar
 
GROWTH OF PHARMACOVIGILANCE IN INDIA Dr Deven V Parmar MD Vice President – Gl...
byUntil ROI
 
Pharmacovigilance system-updated 2025.pptx
byAlaa Fadhel Hassan Alwazni
 
pharmacovigilance pdf (1)
byPrasad Bhat
 
Pharmacovigilance pdf (1)
byPrasad Bhat
 
Pharmacovigilance and Materiovigilance.pdf
byDr. Yuppie Rajasekhar Poonuru
 
Pharmacovigilance AND HIPAA
byPrajal M. Christian
 
Pharmacovigilance Overview
bySivasankaranV
 
Advancing Pharmacovigilance: Safeguarding Drug Safety and Enhancing Public He...
byMedwin Publishers
 
Pharmacovigilance
byPriyesh Pandya
 
basic information resource.pptx
bySiddharthShekharSing4
 
History n progress of pv
byRamavath Aruna
 
Pharmacovigilance-an overview
byDr. Pramod Kumar
 
PHARMACOVIGILANCE - A Worldwide masterkey for Drug Monitoring
byVenugopal N
 
Pharmacovigilance_ Dr Ruchi Kushwaha.pptx
byDr Ruchi Kushwaha
 
establishing_pv_centers_in_industry_AND_NATIONAL_PROGRAMME[1].pptx
byashharnomani
 
PHARMACOVIGILANCE ( PVPI)BY DR SURYA K.pptx
bySurya Ganesh
 

More from Pristyn Research Solutions

PDF
Pristyn Service
byPristyn Research Solutions
 
PDF
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
byPristyn Research Solutions
 
PDF
For all fields Common job interview questions with answers updated in 2022.
byPristyn Research Solutions
 
PPTX
Basics of scientific research writing
byPristyn Research Solutions
 
PPTX
Interview soft skills workplace ethics job attire guide grooming, makeover &a...
byPristyn Research Solutions
 
PPTX
IDEAL Ph.D. SEMINAR VIVA PPT- CHEMISTRY
byPristyn Research Solutions
 
PPTX
Communication & Soft Skills in Pharmacy ideal presentation!
byPristyn Research Solutions
 
PPTX
Clinical research
byPristyn Research Solutions
 
PPTX
NEW DRUG DEVELOPMENT
byPristyn Research Solutions
 
PPTX
Ethics committee
byPristyn Research Solutions
 
PDF
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
byPristyn Research Solutions
 
PDF
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...
byPristyn Research Solutions
 
PDF
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
byPristyn Research Solutions
 
PDF
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
byPristyn Research Solutions
 
PDF
DRUG AND COSMETIC ACT
byPristyn Research Solutions
 
PDF
DRUG ACTION
byPristyn Research Solutions
 
PDF
CDM
byPristyn Research Solutions
 
PPTX
Introduction to clinical research
byPristyn Research Solutions
 
PPTX
Pharmaceutical business management
byPristyn Research Solutions
 
PPTX
Clinical data management web based data capture edc &amp; rdc
byPristyn Research Solutions
 
Pristyn Service
byPristyn Research Solutions
 
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
byPristyn Research Solutions
 
For all fields Common job interview questions with answers updated in 2022.
byPristyn Research Solutions
 
Basics of scientific research writing
byPristyn Research Solutions
 
Interview soft skills workplace ethics job attire guide grooming, makeover &a...
byPristyn Research Solutions
 
IDEAL Ph.D. SEMINAR VIVA PPT- CHEMISTRY
byPristyn Research Solutions
 
Communication & Soft Skills in Pharmacy ideal presentation!
byPristyn Research Solutions
 
Clinical research
byPristyn Research Solutions
 
NEW DRUG DEVELOPMENT
byPristyn Research Solutions
 
Ethics committee
byPristyn Research Solutions
 
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
byPristyn Research Solutions
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS ...
byPristyn Research Solutions
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
byPristyn Research Solutions
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
byPristyn Research Solutions
 
DRUG AND COSMETIC ACT
byPristyn Research Solutions
 
DRUG ACTION
byPristyn Research Solutions
 
CDM
byPristyn Research Solutions
 
Introduction to clinical research
byPristyn Research Solutions
 
Pharmaceutical business management
byPristyn Research Solutions
 
Clinical data management web based data capture edc &amp; rdc
byPristyn Research Solutions
 

Recently uploaded

PPTX
Radiology in pulmo cases part 2 in depth
byprithvinathanai
 
PPTX
Understanding Diabetes Mellitus - A comprehensive guide for nurses and Eviden...
byViresh Mahajani
 
PPTX
Innovations in Chronic Pain Management: From Clinical Idea to Published Research
byDaradia: The Pain Clinic
 
PPTX
PERCEPTION.pptx I SEMESTER STUDENTS BY SHILPA HOTAKAR
bySHILPA HOTAKAR
 
PDF
Role of AI in Autism spectrum disorder (ASD)
byShraddhaJha15
 
PPTX
9.Deformities of humanbody last units of surgery I.pptx
byBolan University of Medical and Health Sciences ,Quetta
 
PPTX
How to find Mounjaro at an affordable price
byobevahealth
 
PPTX
ADRENAL GLAND DISORDERS: A BRIEF OVERVIEW
byhelenmorish
 
PPTX
THYROID GLAND ANATOMY PHYSIOLOGY AND DISORDER
byKrantiKhobragade
 
PDF
preoperative assessment Pheochromocytoma 2025.pdf
byAssist. Prof. Radhwan Hazem Alkhashab
 
PPTX
DEBATE ON LUNG CANCER PACIFIC VS KEYNOTE TRIAL
byKanhu Charan
 
PPT
Remembering Brain Health: Targeting Modifiable Risk Factors and Early Detecti...
byPVI, PeerView Institute for Medical Education
 
PPTX
Herbs As Health Food....pptx ( Pharmacognosy )
byBushraDeshpande
 
PPTX
Gut Microbial Metabolites as Cancer Immunomodulators
byArchitMehta11
 
PPTX
Yasser's Maneuver for Regaining the Consciousness in the Psychogenic Coma.pptx
byYasserMohammedHassan1
 
PPTX
ACTIVE ASSISTED EXERCISE.pptx file by gokul
byGOKULAKRISHNAN JANARTHANAN
 
PDF
Pòster "Virtual Reality in Pain Management"
byBadalona Serveis Assistencials
 
PPTX
NERVOUS SYSTEM11 by Gulshan athbhaiya.pptx
byGulshan Athbhaiya
 
PPTX
monai and radiotherapy: 3D Slicer basic.pptx
bySumitKumar452
 
PPTX
VSWarehouse for Genome Centers: Scalable, Secure Whole-Genome Infrastructure ...
byGolden Helix
 
Radiology in pulmo cases part 2 in depth
byprithvinathanai
 
Understanding Diabetes Mellitus - A comprehensive guide for nurses and Eviden...
byViresh Mahajani
 
Innovations in Chronic Pain Management: From Clinical Idea to Published Research
byDaradia: The Pain Clinic
 
PERCEPTION.pptx I SEMESTER STUDENTS BY SHILPA HOTAKAR
bySHILPA HOTAKAR
 
Role of AI in Autism spectrum disorder (ASD)
byShraddhaJha15
 
9.Deformities of humanbody last units of surgery I.pptx
byBolan University of Medical and Health Sciences ,Quetta
 
How to find Mounjaro at an affordable price
byobevahealth
 
ADRENAL GLAND DISORDERS: A BRIEF OVERVIEW
byhelenmorish
 
THYROID GLAND ANATOMY PHYSIOLOGY AND DISORDER
byKrantiKhobragade
 
preoperative assessment Pheochromocytoma 2025.pdf
byAssist. Prof. Radhwan Hazem Alkhashab
 
DEBATE ON LUNG CANCER PACIFIC VS KEYNOTE TRIAL
byKanhu Charan
 
Remembering Brain Health: Targeting Modifiable Risk Factors and Early Detecti...
byPVI, PeerView Institute for Medical Education
 
Herbs As Health Food....pptx ( Pharmacognosy )
byBushraDeshpande
 
Gut Microbial Metabolites as Cancer Immunomodulators
byArchitMehta11
 
Yasser's Maneuver for Regaining the Consciousness in the Psychogenic Coma.pptx
byYasserMohammedHassan1
 
ACTIVE ASSISTED EXERCISE.pptx file by gokul
byGOKULAKRISHNAN JANARTHANAN
 
Pòster "Virtual Reality in Pain Management"
byBadalona Serveis Assistencials
 
NERVOUS SYSTEM11 by Gulshan athbhaiya.pptx
byGulshan Athbhaiya
 
monai and radiotherapy: 3D Slicer basic.pptx
bySumitKumar452
 
VSWarehouse for Genome Centers: Scalable, Secure Whole-Genome Infrastructure ...
byGolden Helix
 

PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 2022..pdf

  • 1.
    PHARMACOVIGILANCE Updated IN 2022:COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS By Pristyn Research A quick Job interview short guide For Pharma and all Life science jobseekers. info.pristynresearch.com www.pristynresearch.com 9028839789 | 8999717656 All Medical | Biotech |Micro |B.Sc., M.Sc.
  • 2.
    For PV JobInterview with Answers questions 01. Different terms used in PV 02. DEFINITIONS 03. What are the contents? PAN India PV companies list alphabetically. Companies List
  • 3.
    Prepared BY C.E.O &FOUNDER Pristyn Research Solutions AZHER KHAN Scientific writer, Pristyn Research Solutions MRINAL R. GITE
  • 4.
    According to W.H.O-C.C.I.D.MThe science and activities related to the detection, assessment, understanding, prevention & Reporting of adverse effects or any other drug-related problem. What is Pharmacovigilance (PV)? To collect evidence - medicine-related problems. • To build Public confidence • Identification of risk factors • Quantifying risks • Understanding the concepts of ADR, Medical Errors, Public Health Significance, Regulatory Interventions, ADR Monitoring schemes. What are the objectives of PV?
  • 5.
    • Rapid identificationof events that are likely to affect adherence to treatment and determination of their rates, and identification of the risk factors that make these events more likely, to reduce their occurrence; • Identification of signals (i.e., possible causal relationships between an adverse event and a medicine; see Glossary) of ADRs of concern following the introduction of a new drug or drug combination; • Assessment of signals to evaluate causality, clinical relevance, frequency and distribution of ADRs in particular population groups; calculation of rates of events so that: a) Risk can be measured; b) The safety of different medicines can be compared and informed choices made; c) Risk factors can be identified; • Contribution to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefit; Aim of PV
  • 6.
    • Appropriate responseor action in terms of drug registration, drug use and/or training and education for health professionals and the public; • Measurement and evaluation of the outcome of the response or action taken (e.g. reduction in risk, improved medicine use, or improved outcome for patients experiencing a particular ADR); • Timely communication with and recommendations to authorities and the public; • Feedback to the clinicians who provided the information …..Continue…..
  • 7.
    What is Goalof PV? To ensure the benefits of the use of medicine. safeguard the health of the Indian population. International Society of PV (ISOP) This is an important international society. Their website gives information about meetings and training courses. What is MedDRA? MedDRA (Medical Dictionary for Regulatory Activities) is a standardised medical terminology, published by the International Council for Harmonisation, used in particular for coding cases of adverse effects in clinical study reports and PV databases, and to facilitate searches in these databases.
  • 8.
    Manage and relay drugsafety information Maintain current knowledge of global drug safety regulations Participate in the training of operational staff on drug safety issues Summarise clinical safety data, participate in meetings with potential and actual study sponsors Write narratives with medical input from a physician Quality control work of other staff in the department Take on any other task as assigned by the manager or within the capabilities of the Drug Safety Associate. Report SADRs to the Regulatory Authorities WHAT ARE THE Role of Drug Safety Associate ?
  • 9.
    1 2 3 Death/Life-threatening Events: 7 days OtherSerious Events: 15 days Non-serious Events: 90 days What are the due dates for safety reporting? Various manufacturers have set their timelines to avoid any late cases. Timelines change from one drug to another and also on basis of causality and seriousness
  • 10.
    What are thetypes of PV? Two types. 1. Active PV and 2. Passive PV
  • 11.
    Which are differentDatabases used in PV? 1 BaseCon – Safety Base Interchange 3 Ennov Group 5 Clinevo Safety 7 VigiBase 2 4 6 8 Oracle - Argus Safety Database AB Cube – Safety Easy Aris Global - ARISg/ Life Sphere Safety PvNET Beneficial effects? What should a narrative consist of? A narrative should consist of precise and concise information about the source of the report, patient demographics, patient’s medical history, concomitant medications, suspect product details and adverse event details in an orderly manner. The adverse effect of a drug should not be considered without into the account its beneficial effects.
  • 12.
    State the benefitsof PV program This program will increase the knowledge and importance of Pharmacovigilance in the drug discovery process and Clinical Research, Pharmacovigilance is becoming an important part of drug development as it deals with the patients’ safety & efficacy of drug results into new job avenues. The participants after the completion of this would have new economic pursuits as Pharmacovigilance potential opportunities & growth prospects are huge. Pharmacovigilance Programme of India (PVPI) - launched in July 2010. What are Data assessments in PV? 1 2 Aggregated assessment and interpretation 3 4 5 6
  • 13.
    WHAT PRODUCTS DOESPV COVER Medicines Herbal products Biologicals Blood Products Vaccines Traditional & supplementary products Cosmetics Veterinary & Tobacco vigilance Medical devices Which products are covered by PV?
  • 14.
    Methods of signaldetection? Clinical assessment of individual events Clinical review of collated events Record linkage Automated signal detection. There are four methods for identifying signals
  • 15.
    Why PV isrequired after clinical trial?
  • 16.
    Any untoward medicaloccurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. What is an Adverse Drug Event (ADE)? What is the minimum criterion required for a valid case according to WHO? a. An identifiable reporter b. An identifiable patient c. A suspect product d. An adverse drug event When do you consider an event to be serious? If an event is associated with any one of the following, it is considered to be serious Death Life-threatening Congenital anomaly Disability Medically significant
  • 17.
    What do youmean by causality? Causality is the relationship between a set of factors. In Pharmacovigilance, causality is the relationship between the suspect product and the adverse drug event. • Is there a convincing relationship between the drug and the event? • Did the drug actually cause the event? Name some data elements in ICSR Age Gender Race A Drug odse & dosage form Therapy date & Duration Indication B Event onset date Seriousness criterion Event end date and latency. C Dechallenge Rechallenge Action taken D Summary of the report Medicicnes Sugestions E PATIENT DEMOGRAPHICS SUSPECT PRODUCT DETAILS ADVERSE EVENT DETAILS CAUSALITY NARRATIVE WRITING
  • 18.
    What are typesof reports?
  • 19.
    Types of Unsolicited reports Sources of Solicited Reports ✓Direct reports (consumers, healthcare professionals, other) ✓ Medical information enquiries ✓ Literature – via literature searching of medical and scientific journals ✓ Lay literature (press/media) – non- medical/scientific literature ✓ Internet/digital media (website, internet forum, chat room, blog, social network) ✓ Clinical trials ✓ Non-interventional studies ✓ Registries ✓ Post-approval named patient programmes ✓ Patient support programmes (PSPs) ✓ Surveys of patients/HCPs
  • 20.
    Reporter details Date andplace of the report.
  • 21.
    Name the coreregulatory bodies India: IDA Indian Drug Administration previously known as Central Drugs Standard Control Organization (CDSCO) CDSCO Australia: Therapeutic Goods Administration TGA USA: United States Food and drug administration USFDA UK: Medicines and Healthcare Products Regulatory Agency MHRA Europe: European Medicines Agency EMA Canada- Health Canada HC China - National Medical Products Administration (NMPA) NMPA Japan: Ministry of Health, Labour and Welfare MHLW
  • 22.
    What is Volume9A? Volume 9A brings together general guidance on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorization Holders (MAH) and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonization (ICH). Part I deals with Guidelines for Marketing Authorization Holders; Part II deals with Guidelines for Competent Authorities and the Agency; Part III provides the Guidelines for the electronic exchange of Pharmacovigilance in the EU. Part IV provides Guidelines on Pharmacovigilance communication. Volume 9A is presented in four parts:
  • 23.
    What do youknow about E2a, E2b and E2c guidelines? E2a: E2a guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. E2b: E2b guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports. E2c: E2c guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.
  • 24.
    EudraVigilance The data-processing network andmanagement system of the European Union, set up by the EMA to facilitate the electronic exchange, management and scientific assessment of individual case safety reports on all medicinal products approved in the European Economic Area (EEA). It also incorporates data analysis facilities. Medwatch is the FDA’s safety information and adverse event reporting form. It was founded in 1993 and is used for volunteer reporting an adverse event. Patients may be more susceptible to particular ADRs if they also have other health problems, either because of the concomitant condition or from the interaction of the medicines being used to treat the other condition(s). Medwatch Co-morbid conditions Define the terms Given below
  • 25.
    When do youconsider a case to be medically confirmed? A case is considered to be medically confirmed if it contains at least one event confirmed or reported by an HCP (Health Care Professional). Note: HCP can be a physician, nurse, pharmacist, coroner or psychologist. What is CemFlow? CemFlow is a tool maintained by the UMC for database management in cohort event monitoring (CEM). It is web-based and the fields match the data elements on the questionnaires. There are screens for patient demographics, treatment initiation, treatment review and assessment of events. CemFlow is a tool for data entry into an online database maintained by the UMC (Uppsala Monitoring Centre) for CEM. CemFlow provides for entry of cohort data as well as the events.
  • 26.
    Pregnancy Overdose (>MTD) Off label use, Medication error Lackof efficacy Used for Unapproved Indication Misuse Special case scenarios in PV
  • 27.
    The Yellow CardScheme is the UK system for collecting information on the suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored. In 1964, the Scheme was founded after the thalidomide disaster and was developed by Bill Inman. What is the yellow card in PV? What is the blue card in PV? Blue card form is used to report suspected adverse reactions to vaccines and prescription, over-the-counter and complementary medicines in Australia. What are Co-morbid conditions? Patients may be more susceptible to particular ADRs if they also have other health problems, either because of the concomitant condition or from the interaction of the medicines being used to treat the other condition(s).
  • 28.
    NR not resolved RSresolved with sequelae R2 resolving R1 resolved A Outcomes of the event Suitable methods of reporting Telephone E-mail Fax B Internet Moderate Mild Not severe C Seriousness criteria based on intensity Severe Probable Possible Certain D Likely Synonyms for causality- related Synonyms for causality- Unrelated Un-assessable Unclassified Unlikely E
  • 29.
    What is medicationerror? Missuse The situations where the medicine is intentionally and inappropriately used as per the authorised PI or the directions for use on the medicine label. • Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug. Examples of medication errors include misreading or miswriting a prescription. Medication errors that are stopped before harm can occur are sometimes called “near misses” or “close calls” or more formally, a potential adverse drug event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while others are caught before harm can occur (“near- misses”). • Medication errors are more common than adverse drug events, but result in harm less than 1% of the time. About 25% of adverse drug events are due to medication errors.
  • 30.
    The point atwhich a drug is again given to a patient after its previous withdrawal. Re-challenge The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed. De-challenge What is a signal? Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action.
  • 32.
    What is DayZero? Day zero remain the day that the first information was received. Or Day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available. The WHO Drug Dictionary (DD), MedDRA and the WHO Adverse reactions terminology (WHO-ART). WHODD= used for drug coding MedDRA, WHO-ART = coding of events. What is WHO ART, WHO DD and MedDRA and the difference between them?
  • 33.
    What is SUSAR? USAR:An unexpected adverse reaction (UAR) is an adverse reaction that is not consistent with the product information in the SPC. A suspected unexpected serious adverse reaction (SUSAR) is any UAR that at any dose ✓ Results in death ✓ Is life-threatening (i.e. the subject was at risk of death at the time of the event) ✓ Refer to an event that hypothetically might have caused death if it were more severed ✓ Requires hospitalisation or prolongation of existing hospitalisation ✓ Results in persistent or significant disability or incapacity ✓ Is a congenital anomaly or birth defect. ✓ The development of SUSAR is uncommon (unexpected issue) observed during a clinical trial and for which there is a relationship with the experimental drug, whatever the tested drug or its comparator.
  • 34.
    Definitions 02. Terms You ShouldKnow Before Applying For PV
  • 35.
    Absolute risk Risk ina population of exposed persons; the probability of an event affecting members of a particular population (e.g. 1 in 1,000). Absolute risk can be measured over time (incidence) or at a given time (prevalence). Adverse Event (AE) Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Adverse Drug Reaction (ADR) A response that is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or modifies the physiological function of the body. (WHO, 1972). “A response to a medicinal product which is noxious and unintended.”
  • 36.
    Cohort Event Monitoring(CEM) is a prospective, observational study of events that occur during the use of medicines, for intensified follow-up of selected medicinal products phase. Patients are monitored from the time they begin treatment, and for a defined period of time.
  • 37.
    Association Events are associatedwith time but not necessarily linked as cause and effect. Cem-Flow Software developed by UMC for collection and analysis of data in Cohort Event Monitoring. Biological products Medical products prepared from biological material of human, animal or microbiologic Compliance Faithful adherence by the patient to the prescriber’s instructions. De-challenge The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of adverse effects may be observed.
  • 38.
  • 39.
    Data mining A generalterm for computerised extraction of potentially interesting patterns from large data sets is often based on statistical algorithms. A related term with essentially the same meaning is ‘pattern discovery’. In pharmacovigilance, the commonest application of data mining is so called disproportionality analysis, for example using the Information component (IC). Disproportionality analysis Screening of ICSR databases for reporting rates which are higher than expected. For drug- ADR pairs, common measures of disproportionality are the Proportional Reporting Ratio (PRR), the Reporting Odds Ratio (ROR), The Information Component (IC), and the Empirical Bayes Geometrical Mean (EBGM). There are also disproportionality measures for drug-drug-ADR triplets, such as Omega (Ω). Critical terms Some of the terms in WHO-ART are marked as ‘Critical Terms’. These terms either refer to or might be indicative of serious disease states, and warrant special attention, because of their possible association with the risk of serious illness which may lead to more decisive action than reports on other terms
  • 40.
    Effectiveness/risk The balance betweenthe rates of effectiveness of medicine versus the risk of harm is a quantitative assessment of the merit of medicine used in routine clinical practice. Comparative information between therapies is most useful. This is more useful than the efficacy and hazard predictions from pre- marketing information that is limited and based on selected subjects. Efficacy The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard). Harm The nature and extent of actual damage that could be caused by a drug. Not to be confused with risk.
  • 41.
    Epidemiology It is thescience concerned with the study of the factors determining and influencing the frequency and distribution of disease, injury and other health-related events and their causes in a defined human population to establish programs to prevent and control their development and spread. Essential medicines Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Excipients All materials included in making a pharmaceutical formulation (e.g. a tablet) except the active drug substance(s).
  • 42.
    Formulary A listing ofmedicinal drugs with their uses, methods of administration, available dose, dosage forms, side effects, etc, sometimes including their formulas and methods of preparation. Frequency of ADRs In giving an estimate of the frequency of ADRs the following standard categories are recommended: ❖ Very common* > 10% ❖ Common (frequent) >1% and <10% ❖ Uncommon (infrequent) >0.1% and < 1% ❖ Rare >0.01% and <0.1%Very rare* <0.01%
  • 43.
    Generic (multisource product) Theterm ‘generic product’ has somewhat different meanings in different jurisdictions. Generic products may be marketed either under the non- proprietary approved name or under a new brand (proprietary) name. They are usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after the expiry of the patent or other exclusivity rights. Herbal medicine Includes herbs, herbal materials, herbal preparations and finished herbal products.
  • 44.
    Homoeopathy Homoeopathy is atherapeutic system that works on the principle of ‘like treats like’. An illness is treated with a medicine that could produce similar symptoms in a healthy person. The active ingredients are given in the highly diluted form to avoid toxicity. Homoeopathic remedies are virtually 100% safe. Incidence A number of new cases of an outcome that develop over a defined period in a defined population at risk. Information component (IC) The Information component (IC) measures the disproportionality in reporting a drug- ADR pair in an ICSR database relative to the expected reporting based on the drug's overall reporting and the ADR. Positive IC values indicate higher reporting than expected. The IC has also been implemented on electronic health records to detect interesting temporal relationships between drug prescriptions and medical events.
  • 45.
    Individual Case SafetyReport (ICSR) A report that contains ‘information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient’. MedDRA MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO Adverse Reactions Terminology, is now mapped to MedDRA. Medical error “An unintended act (either of omission or commission) or one that does not achieve its intended outcomes.”
  • 46.
    Member countries Countries thatcomply with the criteria for, and have joined the WHO Programme for International Drug Monitoring. Odds and odds ratio Probability of an occurrence p divided by the probability of its non-occurrence (1 - p). The Ratio of the Odds in a given population and the Odds in another population. National Pharmacovigilance centres Organisations recognised by governments to represent their country in the WHO Programme (usually the drug regulatory agency). A single, governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety.
  • 47.
    Omega (Ω) A measureof disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to highlight potential signals of drug-drug interactions. Just like the more established disproportionality measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of reports. A positive Ω indicates higher reporting than expected. Medicinal product available to the public without a prescription. OTC (Over the Counter) medicine PaniFlow Software developed by UMC for collection and analysis of data concerned with vaccinations in a pandemic situation.
  • 48.
    A systematic reviewof the global safety data became available to the manufacturer of a marketed drug during a specific time period. Produced in an internationally agreed format. Periodic Safety Update Report (PSUR) Pharmacoepidemiology Study of the use and effects of drugs in large populations.
  • 49.
  • 50.
    Post-marketing The stage whena drug is generally available on the market. Predisposing factors Any aspect of the patient’s history (other than the drug) which might explain reported adverse events (genetic factors, diet, alcohol consumption, disease history, polypharmacy or use of herbal medicines, for example). Prescription Only Medicine (POM) Medicinal products are available to the public only on prescription.
  • 51.
    Prescription Event Monitoring (PEM) Thesystem created to monitor adverse drug events in a population. Prescribers are requested to report all events, regardless of whether they are suspected adverse events, for identified patients receiving a specified drug. Also more accurately named Cohort Event Monitoring. Prevalence A number of existing cases of an outcome in a defined population at a given point in time. Rational drug use An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best understanding of their appropriateness for the indication and the particular patient, and their benefit, harm effectiveness and risk.
  • 52.
    Prophylaxis Prevention or protection. Recordlinkage Method of assembling information contained in two or more records, e.g. In different sets of medical charts, and vital records such as birth and death certificates. This makes it possible to relate significant health events that are remote from one another in time and place. An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best understanding of their appropriateness for the indication and the particular patient, and their benefit, harm effectiveness and risk. Rational drug use Reference risk Risk in a population of unexposed persons; also called baseline risk. Reference risk can be measured over time (incidence) or at a given time (prevalence). The unexposed population refers to a reference population, as closely comparable to the exposed population as possible, apart from the exposure.
  • 53.
    Relative risk Ratio ofthe risk in an exposed population (absolute risk) and the risk in an unexposed population (reference risk). Relative risk is the result of relative comparison between outcome frequency measurements, e.g. incidences. The probability of harm being caused; the probability (chance, odds) of an occurrence. Risk Regulatory authority The legal authority in any country with the responsibility of regulating all matters relating to drugs. Any unintended effect of a pharmaceutical product occurring at a normal dosage is related to the pharmacological properties of the drug. Side effect
  • 54.
    Serious Adverse Eventor Reaction A serious adverse event or reaction is any untoward medical occurrence that at any dose: ❖ results in death; ❖ requires inpatient hospitalization or prolongation of existing hospitalization; ❖ results in persistent or significant disability/incapacity; ❖ is life-threatening. Triage It is the process of placing a potential adverse event report as a serious/ non- serious case, valid case/ duplicate case/No case, and prioritizing case reporting.
  • 55.
  • 56.
    Reported information ona possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually, more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information. The publication of a signal usually implies the need for some kind of review or action. Signal Summary of Product Characteristics (SPC) A regulatory document is attached to the marketing authorization forms the basis of the product information made available to prescribers and patients. Spontaneous reporting A System whereby case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority.
  • 57.
    Thalidomide Drug was prescribedin the 1950s as a mild sleeping pill and remedy for morning sickness for pregnant women. This led to serious birth defects and the start of modern pharmacovigilance. Returning to favour in the treatment of serious diseases such as cancer and leprosy. Unexpected adverse reaction An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug. Traditional medicines Traditional medicine is the total of the knowledge, skills, and practices based on the theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
  • 58.
    VigiMed Share point-based conferencingfacility, exclusive to member countries of the WHO Programme for International Drug Monitoring for fast communication of topical pharmacovigilance issues. A statistical tool within Vigi-Search with vast statistical material calculated for all Drug- ADR pairs (combinations) available in Vigi-Base. The main features include the disproportionality measure (IC value) stratified in different ways and useful filter capabilities. VigiMine VigiFlow Vigi-Flow is a complete ICSR management system created and maintained by the UMC. It is web-based and built to adhere to the ICH-E2B standard. It can be used as the national database for countries in the WHO Programme as it incorporates tools for report analysis and facilitates sending reports to Vigi-Base.
  • 59.
    VigiBase The name ofthe WHO Global ICSR Database. VigiSearch A search service for accessing ICSRs stored in the Vigi-Base database offered by the UMC to national pharmacovigilance centres and other third-party inquirers. WHO-ART Terminology for coding clinical information concerning drug therapy. WHO-ART is maintained by UMC. WHO Drug Dictionary (WHO DD) The WHO Drug Dictionary is an international classification of drugs providing proprietary and non-proprietary names of medicinal products used in different countries, together with all active ingredients.
  • 60.
    Explain the hierarchyin MedDRA. ❖ System Organ Class (SOC) ❖ High Level Group Term (HLGT) ❖ High Level Term (HLT) ❖ Preferred Term (PT) ❖ Lower Level Term (LLT) What is MedDRA used for? Pre-clinical Phase 1 Phase 2 Phase 3 Phase 4
  • 61.
    Companies list 03. PAN India PVcompanies list alphabetically
  • 62.
    ABBOTTS COGNIZANT I 3GLOBAL DRUG SAFETY LAURUS LABS PARAXEL SRISTEK ACCENTURE CREST. I GATE PATNI COMPUTERS MAHINDRA SATYAMBSG PIRAMAL SUN PHARMA ALEMBIC DIAGNOSEAR CH ICON MAKROCARE PPD SYMOGEN APC PHARMA. DR REDDY’S iMEDGlobal, MANKIND QUANTUM SOLUTIONS SYNOGEN APCER ECRON ACUNOVA IMS HEALTH MEDHIMALAYAS QUINTILES TAKE SOLUTIONS APCER EMCURE INC RESEARCH MEDPACE. SCIFORMIX RATIOPHARM TCS ASTRAZENECA FDC Infocorp Soft Solutions MICRO LABS RX MD THOMSON REUTERS AUROBINDO FORTIS HEALTH CARE INVENTIVE MSD (MERCK) SANTHA BIOTECH USV LIMITED BESTOCHEM G7 INFOTECH IPCA LABORATORIES NEKTAR THERAPEUTICS SCIFORMIX. VIMTA LABS BIOCAD GENPACT IPLEX NORWICH CLINICAL SERVICES SHANTHA BIOTECHNICS WIPRO BIOCON GRANULES JUBILIANT-BIOSYS NOVARTIS SIRO CLINPHARM WNS BIOLOGICAL E. LTD GVK KINAPSE NOVO NORDISK SP softtech WOCKHARD T BLUEFISH HCL LAMBDA OMNICARECLINICA L RESEARCH SRI KRISHNA PHARMA 4C Pharma Solutions
  • 63.
    Important For free SimpleGuidance |Support| Mentorship on jobs & business in India, Watch this short video recorded by the government college https://www.youtube.com/watch?v=UfB2fvTBM3w&t=659s
  • 64.
    For Job OrientedRegular / Weekend /Online Certified Industrial Training | Internship & Short Term Courses with placements assistance and guarantee. Kindly call us @ +91-9028839789. Mumbai Pune Aurangabad Kolhapur Kerala Online/Offline in the below cities of India. Pharmacovigilance | Clinical Research | Clinical Data Management. Drug Regulatory Affairs | Pharma Q.A / Q.C |Pharma Production. Pharma Digital Marketing | R & D |Medical Coding. Medical Transcription | Medical Writing |Research Publications. Course In Course In Course In Course In
  • 68.
    Candidate calls |Counselling by Pistyn experts on Career! Enrollment to placement procedures campus to corporate! Candidate enrolls online / Offline via Pristyn System! Training / Course starts with the regular oral assessment! Industrial Internship + Practical field starts! Placement & certification!
  • 69.
  • 71.