GlobalVigiPub provides you the free online pharmacovigilance training via the posts page on our website. This Guidance on drug safety is good enough to understand the Pharmacovigilance basics and get the roots of pharmacovigilance in detailed too. Just browse the posts and read to get the knowledge on Pharmacovigilance course
Pharmacovigilance Basic Terminologies and Interview Questions
Q: What is Pharmacovigilance?
A: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.
Q: What is need of Pharmacovigilance?
A: All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time. To study the side effects of medicines over longer period, there is need of pharmacovigilance.
Q: What is Applicant?
Ans: An individual or entity who holds the new drug application (NDA), abbreviated new drug application (ANDA), or the biologics license application (BLA).
Readers Note: A product is considered as standout product in the hair regrowth industry. Profollica can regenerate the follicular growth which results your hair back
Q: What is Affiliate?
Ans: Any individual or entity related by employment or organizational structure to the applicant, including all subsidiaries, whether domestic or foreign
Q: What is Causality?
Ans: It is an evaluation of the likelihood that a particular drug is the cause of an adverse event
Q: What is Unexpectedness?
Ans: Adverse experience unlisted in the current FDA-approved labelling for the drug or licensed biological product. This would include any section of the labelling that refers to adverse experience information.
Readers Note: Fight Back against Viruses, Inflammation and Promote Proper Immune System Function with Curcumin 2000 Extract
Q: What is Expectedness?
Ans: Adverse Experience – Adverse experience listed in the current FDA-approved labelling for the drug or licensed biological product. This would include any section of the labelling that refers to adverse experience information.
Q: What is seriousness criteria of a case?
Ans: Serious: Serious Adverse Event is any untoward medical occurrence that at any dose results in:
- Death
- Life-threatening adverse experience
- Initial inpatient hospitalization or prolongation of hospitalization
- Significant or persistent disability/incapacity.
- Congenital anomaly/birth defect (including that occurring in a foetus).
- Important medical event based upon appropriate medical judgment that may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the other outcomes listed in the definition of serious
An emergency room visit that results in admission to the hospital would also qualify for the initial inpatient hospitalization outcome. However, emergency room visits that do not result in admission to the hospital would not qualify
Readers Note: Intensive Stretch Mark Therapy with Skinception is noted treatment for years to come
Q: What is Adverse Reaction?
Ans: An untoward medical occurrence after administration of a medicinal product that necessarily have a causal relationship to the medicinal product.
Q: What is Adverse Event?
Ans: An untoward medical occurrence after administration of a medicinal product that does not necessarily have a causal relationship to the medicinal product.
Readers Note: if you really wants to rid of Alcohol, Just 7 Days to Drink less. Join in Online Alcohol Reduction Program
Q: What is Negative de-challenge?
Ans: Continued presence of an adverse experience after withdrawal of the suspect product.
Q: What is Positive De-challenge?
Ans: Partial or complete disappearance of an adverse experience after withdrawal of the suspect product.
Q: What is re-challenge ?
Ans: Reintroduction of a suspect product suspected of having caused an adverse experience following a positive de-challenge.
Readers Note: Natural support for your cholesterol. The Hypercet cholesterol Formula acts as a general tonic supporting the cardiovascular system. Supports good and bad cholesterol levels within the normal range along with the ability to deal with harmful free radicals
Q: What is Negative Re-challenge?
Ans: Failure of the product, when reintroduced, to produce signs or symptoms similar to those observed when the suspect product was previously introduced.
Q: What is Positive Re-challenge?
Ans: Reoccurrence of similar signs and symptoms upon reintroduction of the suspect product.
Q: What is Disability?
Ans: A substantial disruption in one’s ability to conduct normal life functions.
Readers Note: Quit Smoking. Really it’s a Magic. Get it with Stop Smoking Program
Q: What to be considered as Initial Reporter?
Ans: The original source of information concerning an adverse experience (e.g., consumer, healthcare professional).
Q: What is Life-threatening Adverse Experience?
Ans: An adverse experience that, in the view of the initial reporter, places the patient at immediate risk of death from the adverse experience as it occurred. It does not include an adverse experience that, had it occurred in a more severe form, might have caused death.
Q: What is Lack of Therapeutic Effect?
Ans: Failure to produce the expected pharmacological action for an approved indication.
Readers Note: The clinically proven and natural premium fitness supplements as PrimeGENIX for men over 40 who want to get in shape and have more energy
Q: What is Overdose?
Ans: Exposure to any dose of a medicinal product significantly higher than that recommended in the product information
Q: What is Abuse?
Ans: The intentional non-therapeutic use of a product over-the counter or prescription for a perceived reward or desired non-therapeutic effect.
Q: What is Misuse?
Ans: Exposure to a medicinal product that is intentionally and inappropriately used not in accordance with the authorised product information
Readers Note: Try this unique eyelash growth serum Idol Lash that will help you achieve Longer, Darker, Thicker and Beautiful eyelashes in a matter of weeks
Q: What is Off-Label Usage?
Ans: The intentional use of a medicinal product for a medical condition not listed in the prescribing information, even though it may be effective.
Q: What is Medication error?
Ans: Any unintentional, preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer.
Q: What is Near Miss?
Ans: A prescribing or dispensing error which was identified before reaching the patient thereby preventing a potential adverse drug reaction
Readers Note: Provillus Hair Loss Treatment. Why more people are turning to it to prevent hair loss for MEN, for WOMEN and regrow hair with the only FDA approved ingredient on the market
Q: What is Occupational Exposure?
Ans: The exposure to a medicinal product during the normal course of one’s professional or non-professional occupation
Q: What is Drug exposure during pregnancy?
Ans: Scenario where the embryo or foetus may have been exposed to medicinal products (either through maternal exposure and/or if the suspected medicinal product was taken by the father)
Q: What is Pharmacovigilance? Definition of Pharmacovigilance?
A: Pharmacovigilance is defined by WHO as “the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems”
Readers Note: How to get Smoke-free just in short span
Q: What is Vigibase?
A: VigiBase is the unique WHO global database of individual case safety reports (ICSRs). It is the largest database of its kind in the world, with over 25 million reports of suspected adverse effects of medicines.
Q: What is declaration of Helsinki?
A: The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
Q: What is Eudralex?
A: EudraLex is the collection of rules and regulations governing medicinal products in the European Union
Readers Note: A specially designed The Garcinia UltraPure weight Loss Program is combined with an exciting new breakthrough ingredient that comes with a complete online comprehensive diet and weight loss program to help you lose weight
Q: How many volumes are there in Eudralex?
A: Total 10 volumes
Q: Which volume of Eudralex deals with Pharmacovigilance?
A: Volume 9
Q: What is guidance of Pharmcovigilance for veterinary products?
A: Volume 9 B
Readers Note: A complete protein diet. Pure liquid egg whites are the purest form of protein known to man in the entire world and are 100% bio-available
Q: What is guidance of Pharmcovigilance for Human products?
A: Volume 9 A
Q: What the Black triangle symbol indicates in UK?
A: A Black Triangle symbol is assigned to any new drug or new vaccine or new active substance or a new biosimilar medicine or new combination of medicines or active substances or a new route of administration or a new drug-delivery system.
Q: What is Black Box warnings on Medicinal products in USA?
A: Black Box warnings are also called as Boxed warnings. A drug gets a black box warning when it has potentially serious adverse reactions that could lead to hospitalization, life threatening and death.
Readers Note: A unique 2-step process releases free oxygen to oxidize and lift organic stains away from teeth. Let us begin this patented dental whitening system to remove stains with only one use