IND Sponsor definition

IND Sponsor means Dr. Xxxx Xxxxxxx, Associate Professor-Surgery, (Neurosurgery) Duke University Medical Center.
Sample 1

Examples of IND Sponsor in a sentence

  • Any important medical event can and should be reported as an SAE if deemed appropriate by the Principal Investigator or the IND Sponsor, IND Office.

  • In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. 812.150(b)(1), or other applicable regulations.

  • The Reynolds number (Re) of the inlets had to be used as the similitude criterion [28-33] for airflow in an isothermal mixing ventilated room.

  • Reporting to FDA: • Serious adverse events will be forwarded to FDA by the IND Sponsor (Safety Project Manager IND Office) according to 21 CFR 312.32.

  • Reporting to FDA:• Serious adverse events will be forwarded to FDA by the IND Sponsor (Safety Project Manager IND Office) according to 21 CFR 312.32.

  • Study monitoring visits will occur as defined by the IND Sponsor approved monitoring plan.

  • These evaluations can be done locally if approved by the IND Sponsor.

  • A Medical Monitor, representing the IND Sponsor (OCRPRO), has been appointed for oversight of safety in this clinical study.

  • The IND Sponsor will also submit an IND Annual Report of the progress of the investigation to the FDA as defined in 21 CFR 312.33.

  • Digitalisation of the working environment brings new opportunities with it.

Related to IND Sponsor

  • Project Sponsor means an eligible governmental agency receiving program funds pursuant to an approved application.

  • Prototype Sponsor Means the entity specified on the Adoption Agreement which sponsors this prototype plan.

  • Non-Lead Sponsor means the Note A-2 Holder in its capacity as the sponsor with respect to the Non-Lead Securitization Note in connection with the Non-Lead Securitization.

  • Sponsor shall have the meaning given in the Recitals hereto.

  • Underlier Sponsor means S&P Dow Jones Indices LLC.

  • Asset Management Company/UTI AMC/AMC/Investment Manager means the UTI Asset Management Company Limited incorporated under the Companies Act, 1956, (1 of 1956) [replaced by The Companies Act, 2013 (No.18 of 2013)] and approved as such by Securities and Exchange Board of India (SEBI) under sub-regulation (2) of Regulation 21 to act as the Investment Manager to the schemes of UTI Mutual Fund.

  • Sponsoring entity means a nonprofit corporation, nonprofit cooperative, state governmental entity, local unit of government as defined in ORS 466.706, housing authority or any other person, provided that the person has agreed to restrictive covenants imposed by a nonprofit corporation, nonprofit cooperative, state governmental entity, local unit of government or housing authority.

  • MPCA means the Minnesota Pollution Control Agency or Minnesota Pollution Control Agency staff as delegated by the Minnesota Pollution Control Agency.

  • Retaining Sponsor CREFI, acting as retaining sponsor as such term is defined under Rule 2 of Regulation RR.

  • Financial Sponsor means any Person, including any Subsidiary of such Person, whose principal business activity is acquiring, holding, and selling investments (including controlling interests) in otherwise unrelated companies that each are distinct legal entities with separate management, books and records and bank accounts, whose operations are not integrated with one another and whose financial condition and creditworthiness are independent of the other companies so owned by such Person.

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • School-Sponsored Activity means any activity sponsored, recognized or authorized by the Board and includes activities conducted on or off school property.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Virginia Stormwater Management Program authority or "VSMP authority" means an authority approved by the State Board after September 13, 2011, to operate a Virginia Stormwater Management Program.

  • Portfolio Supervisor means First Trust Advisors L.P. and its successors in interest, or any successor portfolio supervisor appointed as hereinafter provided."

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • 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.

  • Non-Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has not been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Project Implementing Entity means a legal entity (other than the Recipient or the Guarantor): (a) that is responsible for implementing all or a part of the Project; and (b) which is a party to the Project Agreement. If the Bank enters into a Project Agreement with more than one such entity, “Project Implementing Entity” refers separately to each such entity.

  • Culinary water authority means the department, agency, or public entity with

  • Asset Management Plan means a plan created by the department and approved by the state transportation commission or a plan created by a local road agency and approved by the local road agency's governing body that includes provisions for asset inventory, performance goals, risk of failure analysis, anticipated revenues and expenses, performance outcomes, and coordination with other infrastructure owners.

  • Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;