What is a pharmacovigilance system master file?

What is a pharmacovigilance system master file?

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products. The PSMF is not part of the marketing authorisation (MA) dossier and is maintained independently from the MA.

What does PSMF stand for in pharmacovigilance?

Pharmacovigilance System Master File
The Pharmacovigilance System Master File is designed to summarize the pharmacovigilance (PV) system of the Marketing Authorization Holder (MAH) and is business critical.

How do you set up a pharmacovigilance system?

Setting up a pharmacovigilance system requires a great deal of expertise in risk management planning, data collection, analysis, and writing/reporting standards. In addition, you need to invest in a safety database and a network of qualified experts with knowledge of the local language, regulations, and resources.

What details need to be provided in the cover page of PSMF?

Cover Page: 1- The unique number (Revision No.) 2- The name of the MAH, QPPV or LSR (including third party). 3- The name of other concerned MAH(s) (sharing the pharmacovigilance system). If applicable 4- The list of PSMFs/ PSSFs for the MAH (Products with a different pharmacovigilance system) If applicable.

How do you become a QPPV?

The minimum qualifications, training and experience required by a QPPV is a 4 year university degree, which must be within the sphere of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology.

What Mah stands for in pharmacovigilance?

Marketing Authorization Holder
Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called a Marketing Authorization Holder (MAH).

What are pharmacovigilance systems?

Pharmacovigilance system involves collection, monitoring , researching upon, assessing and evaluating information received from health care workers such as doctors, dentists, pharmacists, nurses and other health professionals for understanding the adverse drug reaction.

What is the national coordinating Centre for pharmacovigilance in India?

Indian Pharmacopoeia Commission
The National Coordination Centre-Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India is the WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services.

What is vaccine pharmacovigilance?

Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of any other vaccine- or immunization-related issues.

What is an EU QPPV?

The appointment of a European Union (EU) Qualified Person for Pharmacovigilance (QPPV) is a mandatory requirement for all medicinal products authorised within the EU and they are responsible for ensuring that the Marketing Authorisation Holder’s pharmacovigilance system is compliant with EU requirements.

How do I get a UK PSMF number?

A UK PSMF number can be requested via the MHRA Submissions Portal. You should follow the online instructions for requesting a UK PSMF number and you should receive the number by email immediately upon completion of the form. The address from which the PSMF can be electronically accessed must be in the UK.

What is pharmacovigilance?

An Introduction to the Pharmacovigilance System Master File SCOTT MCCULLOCH, PHARMACOVIGILANCE SOLUTIONS DIRECTOR TransPerfect – Life Sciences November 5, 2013 2. Pharmacovigilance exists to ensure the safety of development for medicinal products. 3.

What is a QPPV’s role in the pharmacovigilance system?

It is therefore an important tool for providing oversight of the pharmacovigilance system and can be used by the EEA QPPV to assist with their oversight.

When was the 9th Annual Conference on Pharmacovigilance held?

Create your free account to continue reading. Presented at Arena’s 9th Annual Pharmacovigilance, Drug Safety and Risk Management Conference in London in November 2013. A Practical Guide on Pharmacovigilance for Beginners, Dr.S.Gunasakaran,MBBS,M…