What are the GVP modules that speak about pharmacovigilance?

Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC) (PDF/80.24 KB)

Risk-management plans.
Pharmacovigilance: regulatory and procedural guidance.

How many GVP modules are there?

This new guidance on good pharmacovigilance practices (GVP) is organised into Modules, and the first seven Modules on prioritised topics are now available for public consultation.

What is GVP module1?

This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the Agency. The Agency likewise maintains a pharmacovigilance system to fulfil its pharmacovigilance activities.

Why is the concept of additional monitoring of medicinal products needed?

Additional monitoring aims to enhance reporting of suspected adverse drug reactions for medicines for which the clinical evidence base is less well developed.

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 is E2B in Pharmacovigilance?

by Pharmacovigilance Team on Mon, Dec 04, 2017. The International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR).

What does QPPV stand for?

QPPV – Qualified Person for Pharmacovigilance (EU QPPV)

What is PV system master file?

A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with respect to one or more authorized medicinal products.

Which drugs have a black triangle?

A black triangle is assigned to any new medicine when approved for the first time if it contains a new active substance, or is a biological medicinal product such as plasma derived medicines, vaccines or biosimilars.

What is Type A adverse drug reaction?

Type A Reactions Type A (augmented) reactions result from an exaggeration of a drug’s normal pharmacological actions when given at the usual therapeutic dose and are normally dose-dependent. Examples include respiratory depression with opioids or bleeding with warfarin.

What is the role of pharmacovigilance?

Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems.

What was the guideline on GVP in 2010?

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.

What are the GVP modules for pharmacovigilance?

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).

Is the EMA guideline on GVP a deliverable?

Guideline on GVP. The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation. Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States. The guideline on GVP is divided into chapters that fall into two categories: modules covering major pharmacovigilance processes;