What is pharmacovigilance severity?
What is pharmacovigilance severity?
The seriousness criterion ‘Life-threatening’ in this context refers to a reaction in which the patient was at risk of death at the time of the reaction; it does not refer to a reaction that hypothetically might have caused death if more severe.
What is Pharmacovigilance master file?
A Pharmacovigilance System Master File (PSMF) is a comprehensive document containing the detailed description of a Marketing Authorization Holders’ (MAH’s) pharmacovigilance (PV) system ensuring the safety of their products.
What are the types of pharmacovigilance?
1.1 Defining pharmacovigilance They may vary in presentation and occurrence and are commonly divided into type A (augmented pharmaceutical response) and type B (bizarre or hypersensitivity) adverse drug reactions (3). throughout a drug’s market life. Pre-marketing safety assessment is generally limited for children.
What is Aesi pharmacovigilance?
Definition of Adverse event of. special interest (AESI) An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.
Who is the manager of GVP module VI?
Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) Effective date: 16-09-2014 By: Dr. Bipin Chandra Bhagath. L MBBS,MD, PGDCR Manager Pharmacovigilance Physician & Clinical Microbiologist 3/5/2017 1
What are the chapters of the GVP guideline?
The guideline on GVP is divided into chapters that fall into two categories: modules covering major pharmacovigilance processes; product- or population-specific considerations.
Where do GVP modules refer to European Medicines Agency?
Where GVP modules refer to the European Medicines Agency’s and the Heads of Medicines Agencies ‘ procedural advice on referral procedures for safety reasons, consult referral procedures page. These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
What is explanatory note in relation to GVP VII?
In relation to the GVP VII module please note that an explanatory note and a question and answer guidance document for assessors have been developed to clarify certain aspects of the single assessment that are specific to nationally authorised products.
