What are the GVP modules?

What are the GVP modules?

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 modules are there in GVP?

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 Module VI?

GVP Module VI: Management and Reporting of Adverse Reactions to Medicinal Products. This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals.

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 Psur and DSUR?

The DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR). It covers drugs, biological, vaccines and combo products. It is a stand-alone document that is not just a data dump but is an analytical document.

What is GVP compliance?

The main objectives that Good Pharmacovigilance Practices (GVP) compliance applicable to pharmaceuticals are: Promoting the safe and effective use of pharmaceutical products, particularly by providing timely information about the safety of medical products to patients, healthcare professionals, and the general public.

What is EudraVigilance database?

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). better product information for medicines authorised in the EEA.

What is EMA in pharmacovigilance?

The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.

What are solicited reports?

Solicited reports means those Reports that are derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers or information gathering on efficacy or …

What is Cioms report?

The CIOMS Form 1 was later the basis for establishing many of the national reporting forms. The initial report of the Working Group was published in 1987, and the final report of the CIOMS Working Group I “International Reporting of Adverse Drug Reactions” was published in 1990.

What is AE in PV?

Adverse Event (AE) Any untoward medical occurrence that happens during treatment with a medical product, whether or not it has a causal relationship with this treatment. Note: Side effect” is a lay-man’s term for Adverse Event and should not be used in pharmacovigilance.

Where can I find a glossary of bowling terms?

This glossary relates mainly to terms applicable to ten-pin bowling. For candlepin terms, see Candlepin bowling#Jargon. An 1892 glossary of bowling terms from a publication of Spalding’s Athletic Library. Lines corresponding to angles of entry for 2°, 4° and 6°.

What does the term ” limited quantity ” mean in Bowling?

Often, the term specifically refers to the limited quantity of balls permitted under rules of a particular competition. Balls in an arsenal are usually chosen to be mutually distinct in coverstock, core characteristics, and pin configuration, to achieve desired ball paths under different lane conditions.

What are the different types of bowling pins?

1 Flat 10: A leave of the 10 pin, in which the 6 pin lies “flat” in the gutter. 2 Flush: A full pocket hit which usually results in sending all ten pins into the pit. 3 Follow-through: The continued motion of the bowling arm after ball release, used to help ensure the ball rolls over a target.

How are breakpoints adjusted in a bowling game?

Breakpoints can be adjusted by making changes in alignment, target, ball, ball surface and ball speed. Refers to a ball that crosses over to the other side of the head pin opposite the side it was thrown (i.e. a Brooklyn strike hit the 1-2 pocket for a right-hander).