PSUR definition

PSUR shall have the meaning set forth in Section 4.1(a).
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PSUR means the Periodic Safety Update Report, a document required by the RAs summarising safety information on an authorised MP collected during a defined period of time, plus certain accumulated safety information, and written according to the ICH E2C(R1) guidelines.
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PSUR has the meaning set forth in Section 5.1 hereof. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Examples of PSUR in a sentence

  • The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.

  • If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

  • As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).

  • If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

  • That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

  • The marketing authorisation holder (MAH) shall provide the competent authority with a consolidated version of the file in respect of quality, safety and efficacy including an evaluation of data contained in suspected adverse reaction reports, Periodic Safety Update Report (PSUR) data (if applicable) and any relevant new information affecting the benefit/risk of the product together with a list of all variations introduced since the MA was granted.

  • Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.

  • The PSUR or PBRER should be compiled in accordance with the requirements of the current ICH E2C Expert Group on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.

  • C gives us the location of a call center, but does not tell us whether the person works there or not.

  • While PSUR and PBRER may be used interchangeably in this guideline, it must be understood that these documents are different.


More Definitions of PSUR

PSUR means a report of Adverse Events in the format required by applicable legislation in the applicable Territory prepared and submitted by a Party in respect of the Product on a periodic basis to Regulatory Authorities, and which shall include updates on urgent safety matters or issues, major signal detection and/or evaluation, and changes in efficacy.
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PSUR means a periodic safety update report required to be submitted to an applicable Regulatory Authority in the Territory.
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PSUR has the meaning set forth in Section 3.9 (Pharmacovigilance).
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PSUR shall have the meaning assigned to such term in Section 9.1.3.
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Related to PSUR

  • CPSU means Central Public Sector Undertaking

  • CEQA means the California Environmental Quality Act.

  • 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.

  • Medical evaluation means the process of assessing an individual's health status that includes a medical history and a physical examination of an individual conducted by a licensed medical practitioner operating within the scope of his license.

  • Licensed behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified Behavior Analyst or a board certified Assistant Behavior Analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization and whom the Board of Psychological Examiners licenses as a Behavior Analyst.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • PSU means Public Sector Undertaking

  • MIB means the Ministry of Information & Broadcasting in India.

  • Baseline means the “Initial Small Business Lending Baseline” set forth on the Initial Supplemental Report (as defined in the Definitive Agreement), subject to adjustment pursuant to Section 3(a).

  • DOI means the United States department of interior.

  • CRO means a contract research organization.

  • biodiversity means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems;

  • Performance Review means a summative evaluation of a teacher other than a beginning teacher and used to determine whether the teacher’s practice meets school district expectations and the Iowa teaching standards, and to determine whether the teacher’s practice meets school district expectations for career advancement in accordance with Iowa Code section 284.7.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • MCO means an organization having a certificate of authority or certificate of registration from the 11 Washington State Office of Insurance Commissioner that contracts with HCA under a comprehensive 12 risk contract to provide prepaid health care services to eligible HCA Enrollees under HCA managed 13 care programs.

  • CMS means the Centers for Medicare and Medicaid Services.

  • PSUs means the outstanding performance share units governed by the performance share unit plan of the Company dated December 16, 2013, as amended from time to time;

  • Peer-reviewed medical literature means a scientific study published only after having been critically

  • ESPD means the European Single Procurement Document completed by the Contractor and sent to the Authority on 27th March 2019

  • PSR means the European Union (Payment Services) Regulations 2018 and any law that amends or replaces them. Some Terms and Conditions are written to make clear they apply only if PSR applies to the Account. For example, PSR applies to accounts where the customer uses the account for payment transactions and can place, transfer or withdraw funds without any restriction. We call such accounts PSR regulated;

  • Target Audience means users on the Criteo Network who will be targeted with relevant performance advertising banners based on the Criteo Technology.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • University Grants Commission means the Commission established under section 4 of the University Grants Commission Act, 1956 (Central Act 3 of 1956);

  • QAP shall have the meaning set forth in Clause 11.2;