Meddra Msso

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In the late 1990s, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardized medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Today, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organizations and health care professionals allows better global protection of patient health.

Company Details

Employees
27
Founded
-
Address
Mclean, Va 22102, Us
Industry
Pharmaceutical Manufacturing
NAICS
Pharmaceutical and Medicine Manufacturing
Medicinal and Botanical Manufacturing
Pharmaceutical Preparation Manufacturing
In-Vitro Diagnostic Substance Manufacturing
Biological Product (except Diagnostic) Manufacturing
Website
meddra.org
HQ
McLean, VA
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News

The Role of MedDRA in Global Pharmacovigilance and Public Health during COVID-19: Pandemic Preparedness and Response - Frontiers

The Role of MedDRA in Global Pharmacovigilance and Public Health during COVID-19: Pandemic Preparedness and Response Frontiers

Basophil activation test and lymphocyte transformation test in cefuroxime-induced anaphylactic reactions - Frontiers

Basophil activation test and lymphocyte transformation test in cefuroxime-induced anaphylactic reactions Frontiers

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine ... - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine ... Centers for Disease Control and Prevention | CDC (.gov)

Anaphylaxis in Clinical Trials of Sublingual Immunotherapy Tablets - ScienceDirect.com

Anaphylaxis in Clinical Trials of Sublingual Immunotherapy Tablets ScienceDirect.com

How to interact with medical terminologies? Formative usability evaluations comparing three approaches for supporting the use of MedDRA by pharmacovigilance specialists - BMC Medical Informatics and Decision Making

How to interact with medical terminologies? Formative usability evaluations comparing three approaches for supporting the use of MedDRA by pharmacovigilance specialists BMC Medical Informatics and Decision Making

Safety Monitoring of COVID-19 mRNA Vaccine Second Booster ... - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of COVID-19 mRNA Vaccine Second Booster ... Centers for Disease Control and Prevention | CDC (.gov)

Evaluation of Natural Language Processing (NLP) systems to annotate drug product labeling with MedDRA terminology - ScienceDirect.com

Evaluation of Natural Language Processing (NLP) systems to annotate drug product labeling with MedDRA terminology ScienceDirect.com

Semantic Queries Expedite MedDRA Terms Selection Thanks to a Dedicated User Interface: A Pilot Study on Five Medical Conditions - Frontiers

Semantic Queries Expedite MedDRA Terms Selection Thanks to a Dedicated User Interface: A Pilot Study on Five Medical Conditions Frontiers

Safety Monitoring of JYNNEOS Vaccine During the 2022 Mpox Outbreak — United States, May 22–October 21, 2022 - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of JYNNEOS Vaccine During the 2022 Mpox Outbreak — United States, May 22–October 21, 2022 Centers for Disease Control and Prevention | CDC (.gov)

Feasibility of disease terminology systems for mapping orphan conditions and therapeutic indications of designated orphan medicines in the European Union - ScienceDirect.com

Feasibility of disease terminology systems for mapping orphan conditions and therapeutic indications of designated orphan medicines in the European Union ScienceDirect.com

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine... - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine... Centers for Disease Control and Prevention | CDC (.gov)

COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says - Frontiers

COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says Frontiers

OntoADR a semantic resource describing adverse drug reactions to support searching, coding, and information retrieval - ScienceDirect.com

OntoADR a semantic resource describing adverse drug reactions to support searching, coding, and information retrieval ScienceDirect.com

COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021 | MMWR - Centers for Disease Control and Prevention | CDC (.gov)

COVID-19 Vaccine Safety in Children Aged 5–11 Years — United States, November 3–December 19, 2021 | MMWR Centers for Disease Control and Prevention | CDC (.gov)

Tolerability profile of paliperidone palmitate formulations: A pharmacovigilance analysis of the EUDRAVigilance database - Frontiers

Tolerability profile of paliperidone palmitate formulations: A pharmacovigilance analysis of the EUDRAVigilance database Frontiers

COVID-19 mRNA Vaccine Safety Among Children Aged 6 months to... - Centers for Disease Control and Prevention | CDC (.gov)

COVID-19 mRNA Vaccine Safety Among Children Aged 6 months to... Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine .. - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine .. Centers for Disease Control and Prevention | CDC (.gov)

COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021 - Centers for Disease Control and Prevention | CDC (.gov)

COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021 Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of mRNA COVID-19 Vaccine Third Doses ... - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of mRNA COVID-19 Vaccine Third Doses ... Centers for Disease Control and Prevention | CDC (.gov)

Notes from the Field: Safety Monitoring of Novavax... - Centers for Disease Control and Prevention | CDC (.gov)

Notes from the Field: Safety Monitoring of Novavax... Centers for Disease Control and Prevention | CDC (.gov)

Drug-Induced Stuttering: Occurrence and Possible Pathways - Frontiers

Drug-Induced Stuttering: Occurrence and Possible Pathways Frontiers

Real-world study of antiresorptive-related osteonecrosis of jaw based on the US food and drug administration adverse event reporting system database - Frontiers

Real-world study of antiresorptive-related osteonecrosis of jaw based on the US food and drug administration adverse event reporting system database Frontiers

Characteristics of drug safety alerts issued by the Spanish Medicines Agency - Frontiers

Characteristics of drug safety alerts issued by the Spanish Medicines Agency Frontiers

First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021 | MMWR - Centers for Disease Control and Prevention | CDC (.gov)

First Month of COVID-19 Vaccine Safety Monitoring — United States, December 14, 2020–January 13, 2021 | MMWR Centers for Disease Control and Prevention | CDC (.gov)

Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms - ScienceDirect.com

Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms ScienceDirect.com

Ontological and Non-Ontological Resources for Associating Medical Dictionary for Regulatory Activities Terms to SNOMED Clinical Terms With Semantic Properties - Frontiers

Ontological and Non-Ontological Resources for Associating Medical Dictionary for Regulatory Activities Terms to SNOMED Clinical Terms With Semantic Properties Frontiers

Serious adverse events reported from the COVID-19 vaccines: A descriptive study based on WHO database - medRxiv

Serious adverse events reported from the COVID-19 vaccines: A descriptive study based on WHO database medRxiv

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018 - Centers for Disease Control and Prevention | CDC (.gov)

Postlicensure Safety Surveillance of Recombinant Zoster Vaccine (Shingrix) — United States, October 2017–June 2018 Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of COVID-19 Vaccine Booster Doses Among ... - Centers for Disease Control and Prevention | CDC (.gov)

Safety Monitoring of COVID-19 Vaccine Booster Doses Among ... Centers for Disease Control and Prevention | CDC (.gov)

ImmPort, toward repurposing of open access immunological assay data for translational and clinical research - Nature

ImmPort, toward repurposing of open access immunological assay data for translational and clinical research Nature

Analysis of Drug-Induced Gastrointestinal Obstruction and Perforation Using the Japanese Adverse Drug Event Report Database - Frontiers

Analysis of Drug-Induced Gastrointestinal Obstruction and Perforation Using the Japanese Adverse Drug Event Report Database Frontiers

Anxiety-Related Adverse Event Clusters After Janssen COVID-19... - Centers for Disease Control and Prevention | CDC (.gov)

Anxiety-Related Adverse Event Clusters After Janssen COVID-19... Centers for Disease Control and Prevention | CDC (.gov)

Safety Profile of Extended-Release Niacin in the AIM-HIGH Trial - The New England Journal of Medicine

Safety Profile of Extended-Release Niacin in the AIM-HIGH Trial The New England Journal of Medicine

Statistical methods leveraging the hierarchical structure of adverse events for signal detection in clinical trials: a scoping review of the methodological literature - BMC Medical Research Methodology

Statistical methods leveraging the hierarchical structure of adverse events for signal detection in clinical trials: a scoping review of the methodological literature BMC Medical Research Methodology

From narrative descriptions to MedDRA: automagically encoding adverse drug reactions - ScienceDirect.com

From narrative descriptions to MedDRA: automagically encoding adverse drug reactions ScienceDirect.com

A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report - medRxiv

A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report medRxiv

COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database - Frontiers

COVID-19 Vaccine-Associated Transient Global Amnesia: A Disproportionality Analysis of the WHO Safety Database Frontiers

Neuropsychiatric Adverse Events of Montelukast: An Analysis of Real-World Datasets and drug−gene Interaction Network - Frontiers

Neuropsychiatric Adverse Events of Montelukast: An Analysis of Real-World Datasets and drug−gene Interaction Network Frontiers

Frequent discussion of insomnia and weight gain with glucocorticoid therapy: an analysis of Twitter posts - Nature

Frequent discussion of insomnia and weight gain with glucocorticoid therapy: an analysis of Twitter posts Nature

Predicting potential adverse events using safety data from marketed drugs - BMC Bioinformatics

Predicting potential adverse events using safety data from marketed drugs BMC Bioinformatics

Pharmacovigilance on cannabidiol as an antiepileptic agent - Frontiers

Pharmacovigilance on cannabidiol as an antiepileptic agent Frontiers

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase - Frontiers

Suspected cutaneous adverse drug reactions reported with traditional medicines: analysis of data for United Nations Asia region from WHO VigiBase Frontiers

Cadec: A corpus of adverse drug event annotations - ScienceDirect.com

Cadec: A corpus of adverse drug event annotations ScienceDirect.com

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