1. What is Pharmacovigilance?
A: The World Health Organisation (WHO), has defined Pharmacovigilance as “Science and activities related to the detection and assessment of adverse effects or other drug-related problems”
Pharmacovigilance, or simply, Pharmacovigilance, is the science of gathering, monitoring, researching and evaluating information from patients and healthcare providers on adverse effects of medicines, biological products and herbal remedies.
2. Why is Pharmacovigilance important?
A: Safety of drugs is dependent on pharmacovigilance. Drug companies can use PV analyses to determine the drug’s safety profile.
These data can be used to further R&D, or submitted to regulatory authorities for access to new markets.
Both clinical research PV and consumer-based PV provide valuable insight into the safety profile of pharmaceutical drugs.
3. What are the minimum criteria required for a valid case?
- An identifiable reporter
- An identifiable patient
- A suspect product
- An adverse drug event
4. What is an Adverse Drug Event (ADE)?
A: Adverse Events are defined by the ICH E2A guideline as “untoward medical occurrences” that occur to a patient or subject during a clinical investigation where a pharmaceutical product was given.
5. What is an Adverse Drug Reaction (ADR)?
A: A negative drug reaction is “a response to a drug that is noxious or unintended” and occurs at doses normally administered in man for the treatment, prophylaxis or diagnosis of disease.
It is important to note that adverse drug reactions and drug use can be linked. An adverse drug reaction, in simple terms, is any harm that occurs when a drug is used at normal dosages.
ICH E2A defines adverse reactions according to the stage in the medicinal product’s development. Adverse reactions are any “noxious or unintended reactions” to the product, even if it has not been commercialized.>
6. What is the difference between an ADE and ADR?
A: Adverse drug reaction and adverse drug event are both adverse occurrences. However, if the cause of adverse occurrence is found then adverse drug reaction can be called. If not, it will be referred to as an adverse drug event.
7. What do you know about ICSR?
A: Individual Case Study Report (ICSR) is the full form of ICSR. It is a report on an adverse event that has occurred to a patient. ICSR is based upon reports/information from healthcare providers and patients from member countries of WHO Programme.
8. Do you have any idea about VigiBase?
A: It is the largest repository of drug safety data across the globe. It is maintained and managed by UMC (Uppsala Monitoring Centre).
9. What is Development Safety Update Report (DSUR)
A: “DSURs” are new, globally harmonised safety documentation that cover the safety overview of pharmaceutical products in their production or during clinical trials.
The new DSUR (described in the ICHE2F Guideline), is heavily based upon the PSUR format that was used to update drug safety records during marketing.
10. When to submit DSUR?
A: Most countries submit the DSUR annually. Companies with open INDs and NDAs (or ex-US equivalents such as CTCs / CTXs and MAs respectively) can also make their regulatory departments harmonise the birthdate for DSURs and PSURs in such a way that a single date for submission is available.
For more information visit http://covalenttrainings.com/course/Clinical-Pharmacovigilance
or CALL +91-9848733309 for Instant Response
You can also reach us via live chat.