Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance

An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.

Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication

A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out bymore than one investigator. Source: FDA

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. Source: ICH E6

An oversight visit to a clinical trial site to review the progress of the study and ensure protocol adherence, accuracy of data, safety of subjects

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol,

An EU Procedure Type in which the competent authority of the lead EU country reviews and approves the application. Other EU member states agree to

CTD Module of the clinical data/reports.

CTD Module of the non clinical data/reports.

CTD Module of the quality documents.

CTD Module of the quality/non clinical/clinical summaries documents.

CTD Module of the regional and administrative information.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which

A clinically validated international medical terminology dictionary used by regulatory authorities in the pharmaceutical industry during the regulatory process, e.g., pre-marketing, post-marketing, data entry.

The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. Source: Marketing

An application made to a European regulatory authority for approval to market a medicine within the European Union. Also use din other markets and as

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended

[FDA] a supplement to an approved application which includes a change(s) to the manufacturing process, including product testing or changes to the facility(ies) involved in