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

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

  • 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) used by the Company is [—].

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

  • The Development Safety Update Report (DSUR) for CTIMPs must be submitted within 60 days of the Development International Birth Date (DIBD), which for the purposes of Cambridge Sponsored CTIMPs will be the anniversary of the clinical trials authorisation from the MHRA.A copy of the DSUR must also be sent to the REC accompanied by the REC CTIMP Safety Report Form (see 7.6).

  • 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.

  • Other mitigation strategies used to offset mitigation are likely to be either net neutral or provide some benefit to raptors and other large birds.

  • The RePHILL Trial Office will provide the MHRA with DSURs. The reports will be submitted within 60 days of the Development International Birth Date (DIBD) of the trial each year until the trial is declared ended.

  • The annual time point is referred to as the Development International Birth Date (DIBD) in EMA guidance.

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 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.

  • 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, 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 Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • 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;

  • Authorized nuclear pharmacist means a pharmacist who:

  • Commencement of Commercial Production means: (i) if a mill is located on the Property, the last day of a period of 40 consecutive days in which, for not less than 30 days, the mill processed ore from the Property at 60% of its rated concentrating capacity; or (ii) if a mill is not located on the Property, the last day of a period of 30 consecutive days during which ore has been shipped from the Property on a reasonably regular basis for the purpose of earning revenues, but any period of time during which ore or concentrate is shipped from the Property for testing purposes, or during which milling operations are undertaken as initial tune-up, shall not be taken into account in determining the date of Commencement of Commercial Production;

  • 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.

  • land development application means the application for a land development permit on a form provided by [local jurisdiction] along with the supporting documentation required in Section [Y]-10(a).

  • international carriage means any carriage in which, according to the contract of carriage, the place of departure and the place of destination are situated in two different States, or in a single State if, according to the contract of carriage or the scheduled itinerary, there is an intermediate port of call in another State;

  • Double Phase Aerosol Air Freshener means an aerosol air freshener with the liquid contents in two or more distinct phases that requires the product container be shaken before use to mix the phases, producing an emulsion.

  • Air freshener means any consumer product including, but not limited to, sprays, wicks, powders, and crystals, designed for the purpose of masking odors or freshening, cleaning, scenting, or deodorizing the air. Air fresheners do not include products that are used on the human body, products that function primarily as cleaning products, disinfectant products claiming to deodorize by killing germs on surfaces, or institutional or industrial disinfectants when offered for sale solely through institutional and industrial channels of distribution. Air fresheners do include spray disinfectants and other products that are expressly represented for use as air fresheners, except institutional and industrial disinfectants when offered for sale through institutional and industrial channels of distribution. To determine whether a product is an air freshener, all verbal and visual representations regarding product use on the label or packaging and in the product's literature and advertising may be considered. The presence of, and representations about, a product's fragrance and ability to deodorize (resulting from surface application) shall not constitute a claim of air freshening.