What is a pharmacovigilance system?
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.
How many modules are there in pharmacovigilance?
The pharmacovigilance system is comprised of 5 modules.
What is PSMF pharmacovigilance?
Postmarketing Expertise for Pharmacovigilance Systems The Pharmacovigilance System Master File is designed to summarize the pharmacovigilance (PV) system of the Marketing Authorization Holder (MAH) and is business critical.
What is Mah in pharmaceutical?
The drug Marketing Authorization Holder (MAH) system is a highlight in China’s revised Drug Administration Law. One of the breakthroughs the MAH system has brought to China’s pharmaceutical industry is that a drug marketing authorization holder no longer has to be the manufacturer.
What are types of pharmacovigilance?
There are four important methods in Pharmacovigilance such as,
- Passive surveillance.
- Active surveillance.
- Cohort event monitoring.
- Targeted Clinical Investigations.
What are the types of pharmacovigilance?
What does QPPV stand for?
Qualified Person for PharmacoVigilance (QPPV)
What is GVP module2?
GVP Module II It reflects the global collection, handling, assessment, storage and reporting of safety information for EU authorised medicinal products, presenting information on the pharmacovigilance system applied at global, regional and local levels.
What is MAA filing?
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
What is MA holder?
MA Holder means the entity that holds the Marketing Approval for a product in a given country.
What are different types of pharmacovigilance?
What are the steps involved in pharmacovigilance?
What are the main areas of pharmacovigilance?
- Operations. The operations sector is the area in which life science graduates normally start their career in the industry.
- Surveillance. This sector mostly concentrates on risk management and signal detection jobs.
- Qualified Persons in Pharmacovigilance.
What is a QP in pharma?
A Qualified Person is a technical term used in EU pharmaceutical regulation. The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.
What is GPP in pharmacovigilance?
Good Pharmacovigilance Practices (GPP) is a quality system for warehouse and distribution centers dedicated for medicines. Internationally accepted pharmaceutical GDP regulations stipulate that distributors of pharmaceutical products must align their operations with the standards.
What are ICH guidelines for pharmacovigilance?
ICH guidelines for pharmacovigilance reporting of adverse drug reactions in the investigational phase of drug development. The ICH has published a number of documents setting standards for safety, both clinical and pre-clinical. Pre-clinical guidelines have an “S” designation e.g. S1, S2 etc.
What are the 4 types of procedures for approval of drug in EU?
EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure.
- The Basic Regulation.
- Investigational New Drug Application.
What is pharmacovigilance and why is it important?
– ensure appropriate, rational and safe use of medical drugs – evaluate the risks and benefits of certain drugs on the market – communicate these risks and possible benefits to patients
What is the process of Pharmacovigilance?
Pharmacovigilance process . As defined in the definition, the Pharmacovigilance process consists of 4 stages. Detection: Collection of Individual Case Safety Reports (ICSRs) Assessment; Understanding and; Prevention of adverse effects; Pharmacovigilance Process Overview Pharmacovigilance Process (Stage 1): Detection
What is the aim of Pharmacovigilance?
– Periodic report compilation – Signal analysis – Risk-benefit assessment
What are the objectives in pharmacovigilance?
– Provide relief pharmacist services for multiple retail drug outlets in Colorado – Provide relief pharmacist coverage for outpatient hospital pharmacies and long term care pharmacies in Colorado – Establish new relationships with clients and maintain existing contracts for the company