What is MedDRA MSSO?
/ Organisation / Maintenance and Support Services Organization. Under the oversight of the ICH MedDRA Management Committee, the key function of the MSSO is to maintain, distribute, and support MedDRA on behalf of MedDRA users.
Which terms are included in MedDRA?
MedDRA includes standardised terms for:
- symptoms, signs, diseases, syndromes and diagnoses.
- medical device malfunctions.
- medication errors.
- medical, social and family history information.
- sites (e.g. application, implant and injection sites)
- medical and surgical procedures.
- approved uses for medications and medical devices.
What is MedDRA coding?
MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans.
What is MedDRA and how is it used?
MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre- marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
What is the pharmacovigilance process?
Pharmacovigilance (PV) is the process of detecting and monitoring adverse drug reactions (ADR), adverse events (ADE), detecting potential ‘signals’ throughout the drug/medical device lifecycle, and also tracking trends in consumers’ sentiments regarding a particular product (drug/medical device) over time.
What is the frequency for MedDRA updates?
The MSSO and JMO release updated MedDRA versions twice a year – in March and September. The English and Japanese translation are released on the 1st of March and September and all other translations are released on the 15th.
What is MSSO in pharmacovigilance?
MSSO. Maintenance and Support Services Organization, the repository, maintainer, and distributor of MedDRA.
Why is MedDRA coding needed?
MedDRA is used for coding therapeutic indications which include signs, symptoms, diseases, diagnosis, or prophylaxis of disease, and modi-fication of functions, coding names and quantitative results of investigations, surgical procedures and medical/social/family history.
Why do we use MedDRA?
MedDRA is used to classify adverse event data from clinical trials; from spontaneous adverse event reports by health care professionals, patients and others; and from other sources of adverse event data.
What is the importance of MedDRA?
MedDRA is an important ICH product for the communication of clinical information. It is mature, current and available in many languages. Use of MedDRA allows information exchange and analysis among many partners over the entire lifespan of products in an efficient manner with accuracy and reproducibility.
What are the main components of pharmacovigilance?
Activities involved in pharmacovigilance
- Case-control study (Retrospective study).
- Prospective study (Cohort study).
- Population statistics.
- Intensive event report.
- The spontaneous report in the case is the population of the single case report.
What is the aim of pharmacovigilance?
The aims of pharmacovigilance are to: — improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions; — improve public health and safety in relation to the use of medicines; — detect problems related to the use of medicines and communicate the findings in a timely …
What are some points to consider when using MedDRA?
Some Points to consider •Obtain clarification of data that are ambiguous, confusing, or unintelligible •Do Not Alter MedDRA :Users must not make ad hoc structural alterations, including changing the primary SOC allocation •Avoid company-specific “work-arounds” for MedDRA deficiencies, submit change request to MSSO •Select current LLTs only
Why do you need a MedDRA MSSO style guide?
The MedDRA MSSO Style Guide was developed to provide a quick reference guide to aid in the writing process, to ensure a consistent look and feel of the MSSO brand in all documentation. In addition to these types of documents, CM services are provided for other documents for the purpose of storage and control.
How does MedDRA learning series coding with MedDRA work?
MedDRA learning series – coding with MedDRA Once the adverse event report or case is received to safety team, the case is triaged and reviewed and the medically most important or “primary event” is chosen. The case will be sent for data entry.
Do you abbreviate MedDRA terms in the text?
A few terms, however, are abbreviated in all forms of writing, e.g., Ph.D., B.S., Mr., Mrs., Dr., Prof. Do not abbreviate MedDRA terms. The first time an acronym appears in the text, expand the acronym and follow it with the acronym in parentheses. Afterwards, use the acronym. Organization (MSSO) has been chartered…