Investigational Medicinal Product definition

Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

Investigational Medicinal Product means a medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial;

Investigational Medicinal Product or “IMP” has the same meaning as that ascribed to that phrase in the CTOA.

Examples of Investigational Medicinal Product in a sentence

• The CRO expressly disclaims any liability in connection with the Investigational Medicinal Product caused by or allegedly caused by the use or misuse of the Investigational Medicinal Product other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO.

• This section does however allow Sponsors to state, for example, that when they expect training in Good Clinical Practice for appropriate team members where the study is a Clinical Trial of an Investigational Medicinal Product, they will accept UK nationally recognised GCP training, training recognised on the Transcelerate mutual recognition scheme, etc.

• The Trust shall ensure that neither administration of the Investigational Medicinal Product to any Clinical Trial Subject nor any other clinical intervention mandated by the Protocol takes place in relation to any such Clinical Trial Subject until it is satisfied that all relevant regulatory approvals and a favourable opinion from the research ethics committee have been obtained.

• The Trust will not, and will ensure that the Investigator and Trial Site Team Members do not, use the name of the Sponsor or CRO or any of their employees, nor the name of the Clinical Trial, nor the name of the Investigational Medicinal Product, in any publicity, advertising or news release without the prior written approval of the Sponsor or CRO as appropriate, such approval not to be unreasonably withheld.

• The CRO shall ensure that the Principal Investigator be provided with the relevant quantities of the Investigational Medicinal Product necessary to perform the Clinical Trial, to be delivered to the Site pharmacy, where the Investigational Medicinal Product shall be documented, prepared and stored in accordance with the applicable laws and the Protocol.

More Definitions of Investigational Medicinal Product

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form,

Investigational Medicinal Product means any product as defined in Article 2(d) of Directive 2001/20/EC;

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a medicinal product that is already the subject of a marketing authorisation, but—

Investigational Medicinal Product means a pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial, and includes a medicinal product which has a marketing authorization but is, for the purposes of the trial—

Investigational Medicinal Product means TKM-Ebola presented in wet format, targeting the Guinea variant of the Ebola virus having the product description set forth in Exhibit 1.1.38.

Investigational Medicinal Product means any pharmaceutical product or placebo being tested or used as a reference in a clinical trial.

Investigational Medicinal Product or “IMP” means the pharmaceutical formulation of the Antibody suitable for use in the Clinical Trial.