Pharmacovigilance Interview Questions : What are the key organisations in PV | Question - 3

What are the key organisations in Pharmacovigilance? Question - 3 Pharmacovigilance Interview Questions by Ramya. Watch all Interview Questions https://bit.ly/3iWqGRV . To know more details visit https://www.greatonlinetraining.com
These are
the WHO,
the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use  ICH, and
the Council for International Organizations of Medical Sciences (CIOMS).
the International Society of Pharmacovigilance (ISoP)

Then, there are country-level regulatory agencies such as US-FDA, UK-MHRA, Japan-PMDA, Health Canada, Australia - TGA, China-FDA, European Medicines Agency, the Central Drugs Standard Control Organization India, etc,.

ISoP:
The International Society of Pharmacovigilance is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally and enhance all aspects of the safe and proper use of medicines, in all countries.

ICH:

The International Council for Harmonisation is a global organization with members from the European Union, the United States and Japan; its goal is to recommend global standards for drug companies and drug regulatory authorities around the world, with its activities overseen by the Steering Committee overseeing harmonization activities.

Efficacy Guidelines :

E2A - E2F Pharmacovigilance guidelines provide details on standards for expedited reporting for clinical trials and post marketing trials, data elements for ICSR reporting, periodic reports like Periodic Benefit-Risk Evaluation Report and Developmental Safety Update reports and pharmacovigilance planning

CIOMS:
The CIOMS, a part of the WHO, that provides guidance on drug safety related topics through its Working Groups.
These groups have published many guidelines for practice, including:
Definition and Application of Terms for Vaccine Pharmacovigilance Safety
Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V)
Development and Rational Use of Standardised MedDRA Queries (SMQs)
Management of Safety Information from Clinical Trials (CIOMS VI)
Development Safety Update Reports (CIOMS VII)
Practical Aspects of Signal Detection in Pharmacovigilance (CIOMS VIII)
Benefit-risk balance for marketed drugs (CIOMS IV)
International Reporting of Periodic Drug Safety Update Summaries (CIOMS II)
Guideline for Preparing Core Clinical Safety Information on Drugs (CIOMS III).
CIOMS Form I form provides a standardised format for the reporting of suspected adverse reactions to any particular medical product

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