Periodic Safety Update Report definition

Periodic Safety Update Report means a report prepared to meet the requirements of the 2001 Directive;

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Periodic Safety Update Report means a report on the safety experience of a drug at defined times, after the drug is registered;

Examples of Periodic Safety Update Report in a sentence

X Periodic Safety Update Report PSURs (Production) Vifor is responsible for the preparation of the PSUR in ICH format.
VGN shall prepare the Periodic Safety Update Report for the Product in the Territory, according to its internal standard operating procedures and in the format as detailed in ICH E2C.
Notwithstanding the foregoing, Lilly shall not be obligated to provide Zosano copies of any Lilly Forteo® Regulatory Filings to the United States Food & Drug Administration for more than the past five (5) years and such copies shall be limited to the IND Annual Report, Developmental Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR).
Periodic Safety Update Report (PSUR), Summary Bridging Report, Addendum Report (ICH E2C (R1)) Periodic benefit-risk evaluation report (PBRER) (ICH E2C (R2)) PSUR (GVP, Module VII) Safety information should be exchanged independent of the causal relationship.
For ADR and Periodic Safety Update Report (PSUR) reporting purposes, reference to a post-authorisation study means any post-authorisation study of which the marketing authorisation holder is aware.
Periodic Safety Update Report (“PSUR”): A report of Adverse Events prepared and submitted on a periodic basis to Regulatory Authorities PSUR includes updates on urgent Safety Issues, major signal detection/evaluation, and changes in efficacy.
Annual summary reports may be submitted in the form of a Periodic Safety Update Report (PSUR) as defined by ICH E2C(R1) guideline.
Spontaneous Reports Non-serious AEs from spontaneous source are sent as separate line-listing within the respective "Periodic Safety Update Report" (see 5.1.3.).
Periodic Safety Update Report (“PSUR”): A report of Adverse Events prepared and submitted on a periodic basis to Regulatory Authorities.
Such aggregate safety reports shall be prepared in accordance with applicable regulatory requirements, and shall include without limitation the Periodic Safety Update Report (PSUR) and the Periodic Adverse Drug Experience Report (PADER).

More Definitions of Periodic Safety Update Report

Periodic Safety Update Report means, subject to any amendment pursuant to the ICH from time to time, a safety report generated at set times and manner according to ICH guidelines for the purpose of demonstrating the current risk/benefit analysis of the Product according to present knowledge and produced to provide a historical perspective on the safety issues surrounding the Product;

Periodic Safety Update Report or “PSUR” means the periodical reports containing the records referred to in Articles 107b–107g of Directive 2001/83/EC (as amended), i.e. the format and content for providing an evaluation of the risk-benefit balance of a medicinal product for submission at defined time points during the post-authorisation phase. If the periodical report is a periodic benefit-risk evaluation report (PBRER) with greater emphasis on benefit than the PSUR, the PBRER should follow the format of the ICH guideline E2C on periodic benefit-risk evaluation report (PBRER). PSUR finalized and submitted by ▇▇▇▇▇▇▇ should follow the format given in applicable legislation in the Territory.

Periodic Safety Update Report means a report containing update safety data pertaining to a registered health product and a scientific evaluation report regarding the benefits and risks of the health product;