Development International Birth Date definition

Development International Birth Date. (or “DIBD”) means the first date that clinical trial authorisation is given by a Regulatory Authority for an interventional clinical trial using the IMP anywhere in the world.
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Examples of Development International Birth Date in a sentence

  • The <sponsor’s name>’s CTA was approved on <date> and this is the Development International Birth Date.

  • For example, there is a common birth date, the Development International Birth Date (DIBD).The report includes information on the marketing authorisation status worldwide, the cumulative exposure in clinical trials and marketing experience (if applicable), and a summary of the important risks.

  • The Development International Birth Date* (DIBD) is used to determine the start of the annual period for the DSUR.

  • The Development International Birth Date (DIBD) to be used will be [DD‑MMM‑YYYY].

  • January 2021 seems to be a fair time to start this which would mean that we would operate under our same ordinance for another calendar year.Merillat said you could make a motion that we go on record recommending an implementation date.

  • Reports must be provided at yearly intervals from the date of the approval of the first trial of the Investigational Medicinal Product anywhere in the world (the Development International Birth Date (DIBD).

  • The report will be submitted within 60 days of the Development International Birth Date of the trial each year until the trial is declared ended.

  • The report period to which each DSUR relates runs for one year, from the Development International Birth Date (DIBD, the first date of Clinical Trial Authorisation and the annual ‘data lock point’ for the study) up to, and including, the day before the DIBD in the next calendar year.

  • It is the responsibility of the CI to ensure a DSUR is submitted per drug on the anniversary of the Development International Birth Date (DIBD).

  • The Development International Birth Date (DIBD) is used to determine the start of the annual period for the DSUR.

Related to Development International Birth Date

  • International Student means a student holding a student visa for the purpose of obtaining an education in Australia and includes a student on a study abroad or international exchange program;

  • international air transport means air transport that passes through the airspace over the territory of more than one State;

  • International air transportation means transportation by air between a place in the United States and a place outside the United States or between two places both of which are outside the United States.

  • international waters means waters falling outside the sovereignty or jurisdiction of any State;

  • international voyage means a voyage from a country to which the present Convention applies to a port outside such country, or conversely.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • international application means an application filed under this Treaty;

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Transit-oriented development means infrastructure improvements that are located within 1/2 mile of a transit station or transit-oriented facility that promotes transit ridership or passenger rail use as determined by the board and approved by the municipality in which it is located.

  • international flight means all flights other than Domestic Flights.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • the International Bureau means the International Bureau of the World Intellectual Property Organization.

  • Commercial driver s license" means:

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • commercial air transport means an aircraft operation involving the transport of passengers, cargo, or mail for remuneration or hire.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Additional Business Centre(s means the city or cities specified as such in the relevant Final Terms;

  • Authorized nuclear pharmacist means a pharmacist who:

  • Commencement of Commercial Production means the first occurrence of Commercial Production in an Area.

  • International airport means an airport:

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Cannabis retailer means any licensed person or entity that purchases or otherwise obtains usable cannabis from cannabis cultivators and cannabis items from cannabis manufacturers or cannabis wholesalers, and sells these to consumers from a retail store, and may use a cannabis delivery service or a certified cannabis handler for the off-premises delivery of cannabis items and related supplies to consumers. A cannabis retailer shall also accept consumer purchases to be fulfilled from its retail store that are presented by a cannabis delivery service which will be delivered by the cannabis delivery service to that consumer.