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)
How many modules are there in pharmacovigilance?
The pharmacovigilance system is comprised of 5 modules.
Which are the 4 elements necessary for considering the the event reportable?
The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.
What is a special situation in pharmacovigilance?
Special Situations are non-standard medical conditions that provide valuable. information (e.g. clinical, safety) about a medicinal product, even when they.
What are the guidelines in pharmacovigilance?
The following principles underpin this guideline: • Planning of pharmacovigilance activities throughout the product life-cycle; • Science-based approach to risk documentation; • Effective collaboration between regulators and industry; • Applicability of the Pharmacovigilance Plan across the three ICH regions.
WHO causality categories for ADR?
ADRs were classified into six categories (certain, probable, possible, unlikely, conditional, unassessable), according to WHO-UMC criteria. Additionally, the judge was required to register the suspected drug(s) to have caused ADR.
What is stage first of QBD?
QbD Validation Strategies: The Process Design Phase Part 1
|Stage of Process Validation||Document|
|Stage 1 Process Design||Control strategy document|
|Final manufacturing process description document|
|Stage 2 Process Qualification||Protocol for process performance qualification (PPD)|
Who can report the ADR AE?
ADEs can be reported directly by the HCP or consumer to the FDA using MedWatch, or they can be reported to the manufacturer who in turn reports them to the FDA (FIGURE 1).
What is nullification in PV?
Case Nullification- When case is found to be duplicate of pre-existing case but submissions of reports was done in previous version. In such scenario, the duplicate case cannot be deleted directly but needs nullification.
What is GCP and ICH?
ICH-GCP. The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
How do I report ADR?
Use one of the methods below to submit voluntary adverse event reports to the FDA:
- Report Online.
- Consumer Reporting Form FDA 3500B.
- Call FDA at 1-800-FDA-1088 to report by telephone.
- Reporting Form FDA 3500 commonly used by health professionals.