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Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch).
2. Pharmacovigilance Pharmacovigilance (PV) Drug Safety It is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse reaction with Pharmaceutical products. "Pharmacovigilance” ( Pharmakon -drug +Vigilare to keep watch) PHARMACOVIGILANCE 3.
The goal of pharmacovigilance is to protect patients and the public wherever possible and to disseminate knowledge among the relevant professional communities and to patients in order to minimise risk.
In 1986, CIOMS set up its first Working Group on pharmacovigilance, a Working Group on International Reporting of Adverse Drug Reactions to explore means of coordinating and standardizing international adverse drug reporting by pharmaceutical manufacturers to regulatory authorities.
5+ years work and teaching experiance in Pharmacovigilance/CDM/ CR
Pharmaco vigilance-Argus safety database
Pharmaco vigilance-Argus safety database
- What is Pharmacovigilance?
Pharmacovigilance has been defined by the World Health Organisation (WHO) as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem”
2. What are the minimum criteria required for a valid case?
- An identifiable reporter
- An identifiable patient
- A suspect product
- An adverse drug event
3. What is an Adverse Drug Event (ADE)?
The ICH E2A guideline describes Adverse Events as any “untoward medical occurrence” which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to that person.
4. What is an Adverse Drug Reaction (ADR)?
ICH E2A characterizes Adverse Reactions according to the stage of the medicinal product’s life cycle. If the product has not yet been marketed, Adverse Reactions are any “noxious and unintended responses” to the product at any dose. The effect of this classification is to reasonably establish that a relationship between the product and the reaction “cannot be ruled out”. Once the product has been placed in the market, “Adverse Reactions” encompass responses which are again “noxious and unintended” but occur at the established routine dosages which have been defined for use in humans to prevent, diagnose, or treat disease or modify “physiological function”.
5. What is the difference between an ADE and ADR?
Adverse drug event and adverse drug reaction both are adverse occurrence but if one finds the causality for adverse occurrence its adverse drug reaction and if one fails to find causality for adverse occurrence then it is referred to as adverse drug event.
6. 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.
7. 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
- Life threatening
- Hospitalization or prolongation of hospitalization.
- Congenital anomaly /Birth Defect
- Requiring intervention to prevent permanent damage or impairment
- Medically significant
8. What is the yellow card in pharmacovigilance?
The Yellow Card Scheme is the UK system for collecting information on 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. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.
9.What is informed consent?
Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information.
10.Name the regulatory bodies in USA, UK, Japan and India?
USA: United States Food and drug administration (USFDA).
UK: European Medicines Agency (EMEA).
Japan: Ministry of Health, Labour and Welfare (MHLW).
India: Central Drugs Standard Control Organization (CDSCO)
11.What is Volume 9A?
Volume 9A brings together “The rules governing medicinal products in the European Union”contains general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorisation Holders and Competent Authorities of medicinal products for human use; it incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH). With the application of the new pharmacovigilance legislation as from July 2012 Volume 9A is replaced by the good pharmacovigilance practice (GVP) guidelines released by the European Medicines Agency.
12.What do the different part of Volume 9A deal with?
Part I deals with Guidelines for Marketing Authorisation 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.
13. Difference between NDA and ANDA?
NDA means New Drug Application. When the sponsor of the new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval, the sponsor submits to the FDA a new drug application.
ANDA means Abbreviated New Drug Application. It contains data that, when submitted to FDA, provides for the review and ultimate approval of a generic drug product.
14.What are the phases of clinical trials?
Phase I studies assess the safety of a drug or device.
Phase II studies test the efficacy of a drug or device.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.
15. What do you mean by MedDRA?
Medical Dictionary for Regulatory Activities.
16.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)
Suspected Unexpected Serious Adverse Reaction
Serious Adverse Event
Council for International Organizations of Medical Sciences
Adverse Drug Event
Suspected Serious Adverse Reaction
Adverse Drug Reaction
Individual Case Safety Report
Periodic Safety Update Report
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Health Insurance Portability and Accountability Act
Electronic Standards for the Transfer of Regulatory Information
International Birth Date
18. What do you know about E2a, E2b and E2c guidelines?
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- E2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports
- E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
- E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
- E2C (R2) Periodic Benefit-Risk Evaluation Report
19.What is IND approval?
The United States Food and Drug Administration’s Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
20.What is EudraVigilance?
The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.
Course Batch Timings
Live Instructor Led Course
100-120 hrs of Class room or Online Live Instructor-led Classes conducting by industry domain specific professionals with lab support. Weekday class: 50 sessions of 2 hours each. and Weekend class:32 sessions (16 weekends) of 3 hours each.
Live project or Real-life Case Studies
Live project based on any of the selected use cases, involving DATA SCIENCE.
Each class will be followed by practical assignments and interview questions which can be completed before the next class.
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