Development Safety Update Report definition

Development Safety Update Report. (or “DSUR”) means a periodic safety report in relation to use of the IMP in the Clinical Trial which: (i) is written by or on behalf of the Charity in accordance with the Charity’s Standard Operating Procedures; (ii) meets the standards of the ICH Guidelines for Development Safety Update Reports as per ICH Topic E2F; and (iii) is required to be submitted annually to the Regulatory Authority in each ICH member state in which the clinical trial is conducted (and to the applicable Ethics Committee) within 60 days of the anniversary of the date of the DIBD.
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Development Safety Update Report. (or “DSUR”) means a periodic safety report in relation to use of the IMP in the Clinical Trial which: (i) is written by the Charity in accordance with the Charity’s standard operating procedures or by the Company; (ii) meets the standards of the ICH Guidelines for Development Safety Update Reports as per ICH Topic E2F; and (iii) is required to be submitted annually to the Regulatory Authority in each ICH member state in which the clinical trial is conducted (and to the applicable Ethics Committee) within [***] of the anniversary of the date of the DIBD.
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Development Safety Update Report. (or “DSUR”) means a periodic safety report in relation to use of the IMP in the Clinical Trial which: (i) is written by or on behalf of the Charity in accordance with the Charity’s Standard Operating Procedures; (ii) meets the standards of the ICH Guidelines for Development Safety Update Reports as per ICH Topic E2F; and (iii) is required to be submitted annually to the Regulatory Authority in each ICH member state in which the clinical trial is conducted (and to the applicable Ethics Committee) within 60 days of the anniversary of the date of the DIBD. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential Portions are marked: [***].
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Examples of Development Safety Update Report in a sentence

  • The term “DSUR” shall mean the International Conference on Harmonization’s Development Safety Update Report which provides a brief overview of safety for a project on an annual basis.

  • The Party responsible for the Development Safety Update Report or Global Development Safety Update Report shall provide the other Party with a draft for review.

  • X Development Safety Update Report (DSUR), (clinical trials) The sponsor is responsible for the preparation of the Development Safety Update Report.

  • No communication regarding omilancor has been conducted with the FDA since November 6, 2021 except a Development Safety Update Report submitted in August of 2022.

  • The Development Safety Update Report (DSUR) will be prepared annually for safety information collected over the period of one year starting from the date of the first regulatory approval granted (CTA approval dated dd/mmm/yyyy).

  • In addition, as appropriate, such Pharmacovigilance Agreement shall include the safety data exchange procedures governing the exchange of information affecting the class (e.g., Serious Adverse Events, emerging safety issues) and address responsibilities for Development Safety Update Report (“DSUR”), Periodic Safety Update Reports (“PSUR”) and Risk Management Plans (“RMP”).

  • Cara will also provide the DSUR (Development Safety Update Report) and the PBRER (Periodic Benefit-Risk Evaluation Report) so that Maruishi can submit the report to the Regulatory Authority by the due date.

  • Any periodic reports (e.g. Development Safety Update Report (DSUR)), shall be transmitted to Sanofi by the Institution at the time of submission to Regulatory Authority.

  • Allergan will provide Molecular Partners with reasonable access to safety data relating to such Licensed Products from such safety database to the extent required under applicable Law and the periodic safety reports that have been submitted to Regulatory Authorities, including, if submitted, any Development Safety Update Report (DSUR).


More Definitions of Development Safety Update Report

Development Safety Update Report or “DSUR” means a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation (pursuant to FDA Guidance for Industry E2F August 2011). A DSUR may be submitted to the FDA in place of an IND Annual Report.
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Development Safety Update Report has the meaning set forth in Section 3.9 (Pharmacovigilance).
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Development Safety Update Report or “DSUR” means a document within the meaning of ICH Guideline E2F (Development Safety Update Report).
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Development Safety Update Report. (or “DSUR”) means a periodic safety report in relation to use of the IMP in the Clinical Trial which: (i) is written by or on behalf of the Charity in accordance with the Charity’s Standard Operating Procedures; (ii) meets the standards of the ICH Guidelines for Development Safety Update Reports as per ICH Topic E2F; and (iii) is required to be submitted annually to the Regulatory Authority in each ICH member state in which the clinical trial is conducted (and to the applicable Ethics Committee) within 60 days of the anniversary of the date of the DIBD. Confidential treatment has been requested for certain portions of this exhibit pursuant to a request for confidential treatment under Rule 24b-2 of the Exchange Act of 1934, as amended. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Confidential portions are marked: [***].
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Related to Development Safety Update Report

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.