A (5) | B (1) | C (14) | D (2) | E (14) | F (4) | G (1) | H (1) | I (14) | J (1) | L (1) | M (4) | N (4) | O (1) | P (15) | Q (2) | R (2) | S (7) | T (2) | V (1)

Latest Glossary Definitions

Anonymization Report (AR)

Part of the Policy 70 submission package. It should describe the methodology of the anonymisation applied in the submitted clinical reports, and how the risk of re-identification has been addressed.

Integrated summary of safety (ISS)

Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.

Good clinical practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are accurate, and that the rights, integrity, and confidentiality of trial subjects ar

Briefing book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.

Paediatric investigation plan (PIP)

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children in Europe.

Commercially confidential information (CCI)

In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.

Clinical evaluation report (CER)

Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.

Justification table

In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.

Anonymization

The process of rendering data into a form which does not identify individuals and where identification is not likely to take place, for example to comply with the requirements of Policy 70. 

Pages