Rapid submission of an ICSR to the Regulatory Authorities in compliance with the legislation and local regulatory guidelines.

ADR consistent with the reference safety information (Investigator’s brochure for an investigational product, summary of product characteristics) for an approved product.

The EMA’s system to support the electronic exchange, management, and evaluation of ICSRs related to all medicinal products authorized in the European Economic Area (EEA).

European collaboration that established a collection of DNA samples for studying genes which influence SARs or ADRs, for the purpose of a better understanding of

The ability of a drug to produce the intended effect (scientific evaluation).

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source: Clinicaltrials.gov

The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study. Source:

Principal indicator(s) used for assessing the primary question (i.e., hypothesis) of a clinical trial. A variable that pertains to the efficacy or safety evaluations of

See Patient-Reported Outcome (PRO) – ePRO collects this information electronically with an app, wearable, web page, etc.

System capturing subject Case Report Form information.

The eXtended EudraVigilance Product Report Message (XEVPRM) is the message format for sending XEVMPD messages to EMA.

The Extended EudraVigilance Medicinal Dictionary (XEVMPD) is the EMA’s current database for tracking pharmaceutical product data for drug safety monitoring and tracking. XEVMPD will gradually

Any ingredient intentionally added to a drug or biologic that is not intended to have a therapeutic effect but may improve product delivery. Examples of

An agency of the European Union in charge of the evaluation and supervision of medicinal products.

The European Economic Area (EEA) is a collection of European countries, primarily made up of the EU nations with the addition of other participating countries

The EDQM is a leading organisation that protects public health by: enabling the development, supporting the implementation and monitoring the application of quality standards for

Structured information part of the eCTD module 1 specific to the product and the application information (full name, applicant, regulatory activity, type of application, procedure

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions [including eCTD]. The FDA ESG enables

[FDA] Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the

PDF fillable form included in EMA human and vet MAAs and Variations, which will be replaced by DADI. Source: http://esubmission.ema.europa.eu/eaf/

[FDA] A supplement to an approved application proposing to make one or more related changes from among the following changes to product labeling: Add or

Criteria published by various Health Authorities that define technical criteria for accepting an eCTD submission. Validation criteria may apply to XML backbones, files, folder structures

The Submission XML Table of Contents file which provides an interface for industry-to-agency transfer of regulatory information that takes into consideration the facilitation of the

An electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. For