What is GVP module?
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.
What is GVP in clinical trials?
Good Pharmacovigilance Practices (GVP): A Quick-Guide. Advances in pharmaceutical research continue to save lives, alleviate pain, and prevent disease. One result of such progress is a continuous evolution in how the safety and efficacy of these incredible medicines are monitored.
What is GVP Module VI?
Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected. adverse reactions to medicinal products (Rev 2) Date for coming into effect of first version.
What does GVP stand for in pharmaceutical industry?
Guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal p. Page 1. See websites for contact details. European Medicines Agency www.ema.europa.eu. Heads of Medicines Agencies www.hma.eu.
What does a QPPV do?
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU.
What does QPPV stand for?
Qualified Person for PharmacoVigilance (QPPV)
What is GCP and GVP?
Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP) inspections. Swissmedic inspects clinical trials of medicinal products conducted in Switzerland on a random basis according to defined risk criteria.
Which database are used by EMA for medical literature monitoring?
the EudraVigilance database
For further details please refer to the Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (Doc. Ref. EMA/161530/2014).
What is invalid case in pharmacovigilance?
Case to be considered as invalid for below criteria: A report referring to a definite number of patients should not be regarded as a case until the minimum four criteria for case reporting are met.
What is valid case in pharmacovigilance?
The criteria for a valid case are: ● an identifiable patient; ● a suspect drug; ● a suspect reaction; ● an identifiable HCP reporter. When one or more of these criteria are missing, it is expected that the MAH attempts to follow the case up in order to validate the report.
Why pharmacovigilance is done?
Essentially, it is drug safety. Pharmacovigilance ensures the rigorous testing of clinical drugs to improve patient care and reduce the risk of negative side effects. Present throughout the drug lifecycle, PV certifies whether a drug works and if it is safe to use.
What is required for pharmacovigilance?
The basic qualifications for a career in pharmacovigilance include undergraduate or graduate degree in pharmacy, human or veterinary medicine, nursing, biochemistry, biotechnology, microbiology or allied health sciences.
What is the new EMA guideline on GVP module VII (PSUR)?
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR). The explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the Periodic Safety Update Single Assessment (PSUSA) process.
What are the different GVP modules?
GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency’s website (see bullet points below Final GVP modules table).
What is the explanatory note to good pharmacovigilance Practices module VII?
The explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the Periodic Safety Update Single Assessment (PSUSA) process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module VII, which will eventually replace it.
What are the chapters of the guideline on GVP?
The guideline on GVP is divided into chapters that fall into two categories: modules covering major pharmacovigilance processes; product- or population-specific considerations.