Trial Notification definition

Trial Notification has the meaning contained in Section 4.4.

Examples of Trial Notification in a sentence

  • There are two schemes under which clinical trials involving a new therapeutic good or new uses of a therapeutic good can be conducted in Australia: the Clinical Trial Notification (CTN) scheme and the Clinical Trial Exemption (CTX) scheme.

  • Within ninety (90) days of delivery of the Trial Notification by Bayer, the Parties shall enter into a written pharmacovigilance agreement (the “PV Agreement”), which shall set forth rules and procedures concerning pharmacovigilance issues.

  • Medicines access in clinical trials setting Australians may also access TGA unapproved medicines under the Clinical Trial Exemption (CTX) and the Clinical Trial Notification (CTN) Schemes.

  • Surgical / Radiotherapy Procedure*If “Drug / Biologic” is chosen, please indicate the Phase of the trial, e.g. Phase I, Phase IIa.If a Clinical Trial Certificate, Clinical Trial Authorisation or Clinical Trial Notification is required, the Principal Investigator must be a locally registered doctor or dentist.

  • Once satisfactory animal and in vitro data has been collected and analyzed, the drug developers must file a Clinical Trial Notification (CTN) with the MHLW before commencing human clinical trials.

  • Countries with such bilateral agreements with Japan include Switzerland, the United Kingdom, Germany, France, Holland and Sweden.153 b) Clinical Trial Notification: 147Id. at 17.148Id. at 12.149Id. at 12.150Id. at 26.151Id. at 12.152Id. at 27.153Id. at 27.

  • The application of Clinical Trial Notification (CTN) had been submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in December, but the CTN has been once withdrawn because we found in the process of reviewing questions from PMDA that a lesser number of cases may be required than initially anticipated and the necessity of revision including acquisition of results for ongoing non-clinical trials.

  • The TGA administers two schemes under which clinical trials involving therapeutic goods may be conducted - The Clinical Trial Notification (CTN) Scheme and the Clinical Trial Exemption (CTX) Scheme.

  • There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia: the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.

  • Whereas illuccix® utilises PET, TLX599-CDx employs SPECT, a diagnostic imaging technology that is widely available in healthcare facilities throughout the world.Prostate cancer therapyTelix’s ProstACT trial of TLX591 was granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the TGA in May 2021.

Related to Trial Notification

  • Written Notification means an electronic document (including faxes, emails, internal mail on the client terminal etc.) or an announcement on the Company's website.

  • DDA Notification has the meaning provided therefor in Section 6.13(a)(i).

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • Additional Disclosure Notification The form of notification to be included with any Additional Form 10-D Disclosure, Additional Form 10-K Disclosure or Form 8-K Disclosure Information which is attached to this Agreement as Exhibit W.

  • 1940 Act Notification means a notification of registration of the Fund as an investment company under the 1940 Act on Form N-8A, as the 1940 Act Notification may be amended from time to time.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • notification means a notification published in the Official Gazette;

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Breach Notification Rule means the HIPAA Regulation that is codified at 45 C.F.R. Parts 160 and 164, Subparts A and D.

  • Notice of Appeal means a notice given pursuant to Condition 6.2.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Administrative Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Borrower pursuant to the terms of the Purchase and Sale Agreement and the Loan Assignment by which the Transferor effects such conveyance.

  • Legal notice means every notice required by law or by order of a court to be published in a newspaper or other publication, except notices required by private and local laws to be published in newspapers, and includes all of the following:

  • Defects Notification Period means the period for notifying defects in the Works or a Section (as the case may be) under Sub-Clause 11.1 [Completion of Outstanding Work and Remedying Defects], which extends over 365 days except if otherwise stated in the SCC (with any extension under Sub-Clause 11.3 [Extension of Defects Notification Period]), calculated from the date on which the Works or Section is completed as certified under Sub-Clause 10.1[Taking Over of the Works and Sections].

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • Relevant Supervisory Consent means, in relation to any redemption or purchase of the Notes, any required permission of the Relevant Regulator applicable to the Company or the Relevant UK Resolution Authority (as applicable). For the avoidance of doubt, Relevant Supervisory Consent will not be required if either (i) none of the Debt Securities qualify as part of the Issuer’s regulatory capital, or own funds and eligible liabilities or loss absorbing capacity instruments, as the case may be, each pursuant to the Loss Absorption Regulations, (ii) the relevant Debt Securities are repurchased for market-making purposes in accordance with any permission given by the Relevant Regulator pursuant to the Loss Absorption Regulations within the limits prescribed in such permission or (iii) the relevant Debt Securities are being redeemed or repurchased pursuant to any general prior permission granted by the Relevant Regulator or the Relevant UK Resolution Authority (as applicable) pursuant to the Loss Absorption Regulations within the limits prescribed in such permission.

  • Notification of Claim means the process of intimating a claim to the insurer or TPA through any of the recognized modes of communication.

  • General Notice means any notice given in accordance with this Agreement other than a Transfer Notice;

  • Email Notice means the legal notice summarizing the proposed Settlement terms, as approved by Class Counsel, Facebook’s Counsel, and the Court, to be provided to Class Members (including Minor Subclass Members), under Section 3.3 of this Agreement via electronic mail or the Facebook domain of xxx.xxxxxxxx.xxx. The Email Notice must be substantially similar to the form attached hereto as Exhibit 3.

  • Initial Notice shall have the meaning set forth in Section 7.1.