Category: E

Expedited Reporting

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

Read More »

Expected Adverse Drug Reaction

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

Read More »

EudraVigilance

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).

Read More »

EUDRAGENE

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

Read More »

Exclusion Criteria

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

Read More »

Enrollment

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:

Read More »

Endpoint

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

Read More »

Excipient

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

Read More »

Envelope

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

Read More »

Electronic Signature

[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

Read More »

Efficacy Supplement

[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

Read More »

eCTD Validation Criteria

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

Read More »

eCTD Backbone

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

Read More »

eCopy

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

Read More »