- What is GVP?
Good Pharmacovigilance Practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.
GVP guidelines are divided into chapters which include two categories:
- modules covering the most important pharmacovigilance processes
- product- or population-specific issues
2. What Are Data Assessments In Pharmacovigilance?
Data assessments are:
- Individual case report assessment
- Aggregated assessment and interpretation
- Signal detection
- Interactions and risk factors
- Serial study
- Frequency
- Estimation
3. When were GVP guidelines implemented?
They were implemented from July 2012
4. What is the DSUR Frequency?
The first DSUR period should not be longer than 1 year. The DSUR is always submitted on a yearly basis.
5. What is PADER frequency?
PADERs quarterly during the first 3 years. Annually thereafter
6. What is an Orphan Drug?
Drug (or biological product) used for the prevention, diagnosis or treatment of a Rare Disease or diagnosis of a disease that is life-threatening or chronically debilitating.
7. What Is An Iq Document?
Installation Qualifications are a collection of test cases used to verify the proper installation of a System. Installation Qualifications must be performed before completing Operational Qualification and Performance Qualification.
8. What Is Dead Leg?
A dead leg is defined as an area in a piping system where liquid can become stagnant and not be exchanged during flushing.
9. What is SAS?
SAS means Statistical Analysis System, which is an integrated set of software products.
10. What is Polypharmacy?
The concomitant use of more than one drug, sometimes prescribed by different practitioners.
11. What is VigiBase?
The name of the WHO Global ICSR Database.
12. What is VigiFlow?
VigiFlow is a complete ICSR management system created and maintained by the UMC.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 VigiBase.
13. What is Vigisearch?
This is a custom search service offered by the UMC to third-party inquirers for which several types of standard presentation are available.
14. What is Vigimed?
E-mail conferencing facility, exclusive to member countries of the WHO Programme for International Drug Monitoring.
15. What is PDV?
The logical area in the memory is represented by PDV or Program Data Vector. At the time, SAS creates a database of one observation at a time. An input buffer is created at the time of compilation which holds a record from an external file. The PDV is created following the input buffer creation.
16. What is Caveat document?
The formal advisory warning accompanying data release from the WHO Global ICSR Database: it specifies the conditions and reservations applying to interpretations and use of the data.
17. What is Data-mining?
At the UMC, the use of an automated tool, based on Bayesian logic, for the scanning of the WHO database (Vigibase) in the process of detecting drug-adverse reaction associations: the BCPNN. Knowledge-detection is the preferred term for the process.
18. What is Neural network?
A type of artificial intelligence used in the BCPNN to scan the WHO ADR database (Vigibase).
19. What is Martindale?
One of the prime reference sources for information about drugs throughout the world. Published by the Pharmaceutical Press, UK.
20. What is Number needed to harm (NNH)?
The number needed to harm (NNH) is an epidemiological measure that indicates how many patients on average need to be exposed to a risk-factor over a specific period to cause harm in an average of one patient who would not otherwise have been harmed. It is defined as the inverse of the attributable risk.
21. What are Excipients?
Materials included to make a pharmaceutical formulation (e.g. a tablet) apart from the active drug substance, e.g. fillers, stabilisers, flavouring agents, colouring agents.
22. What are SSFFCs?
There is currently no universally agreed definition of what used to be widely known as ‘Counterfeit medicine’. Since the 70th World Health Assembly in 2017, WHO is using the term “Substandard and Falsified (SF) medical products.
23. What is Ames test?
This test for genotoxicity, developed in the 1970s, determines the reversion of a mutant his gene in Salmonella typhimurium when exposed to a genotoxic agent that causes base changes affecting the mutant gene.
24. What are immunoinformatics?
The application of informatics techniques to molecules of the immune system. One of the key goals of immunoinformatics is the development of computer aided vaccine design (CAVD), or computational vaccinology, and its application to the search for new vaccines. Key to solving this challenge is the prediction of immunogenicity, be that at the level of epitope, subunit vaccine or attenuated pathogen.
25. What is Post-authorization safety study(PASS)?
A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures. The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee(PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results.
26. What are Xenobiotics?
A compound foreign to an organism. From the Greek xenox = foreign, bios = life. Xenobiotics include drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
27. What is Developmental International Birth Date?
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR is the first anniversary of the DIBD
28. What is ADME/Tox?
Studies undertaken to determine the Absorption, Distribution, Metabolism, Excretion, and Toxicology properties of compounds.
29. What is MedWatch?
A system maintained by the U.S. Food & Drug Administration (FDA) for the voluntary reporting of adverse events, potential and actual medical product errors, and product quality problems associated with the use of FDA-regulated medicines, biologics, devices, and dietary supplements.
30. What are the modules associated with GVP
- Module I: – Quality System
- Module III, IV: – Inspections and audits
- Module V Risk management system
- Module VI Reporting of adverse reactions
- Module VII PSUR
- Module VIII PASS
- Module IX Signal management
- Module X Additional monitoring
- Module XV Safety communication