Phase IV Clinical Study definition
Phase IV Clinical Study means a product support clinical trial of a Product that is commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Study may include epidemiological studies, modeling and pharmacoeconomic studies, “post-marketing surveillance trials” and investigator-sponsored Clinical Trials studying a Product that are approved by the JCC and that otherwise fit the foregoing definition.
Phase IV Clinical Study means any post-marketing Approval clinical study, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drug’s risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time.
Phase IV Clinical Study. Phase IV Clinical Study means a human clinical study initiated in a country for the Licensed Product in an approved indication after receipt of Regulatory Approval for the Licensed Product for such indication in such country.
Examples of Phase IV Clinical Study in a sentence
Kamada shall submit to Chiesi for review and approval, such approval not to be unreasonably withheld, conditioned or denied, each of the above Phase IV Clinical Study plans and protocols in advance, while Kamada shall, at all times during the conduct of the Phase IV Clinical Studies, keep Chiesi reasonably and promptly informed of all material activities and results thereunder and shall consult with Chiesi as reasonably requested by Chiesi.
In the event Genzyme experiences a Change of Control, Genzyme’s successor shall assume all of the rights and obligations of Genzyme as provided for in Section 13.3.1 above, including but not limited to: (a) Genzyme’s performance obligations under any Development Plan during a Development Term, and (b) Genzyme’s obligations with regards to any Phase IV Clinical Study of a Product for an Indication in the Genzyme Territory.
Columbia shall own and have unrestricted rights to the clinical data generated as a result of each Phase IV Clinical Study to be filed in connection with Columbia's regulatory submissions both within and outside the Territory.
More Definitions of Phase IV Clinical Study
Phase IV Clinical Study means a clinical study of a Licensed Product commenced after FDA Regulatory Approval for such Licensed Product in order to (a) support Commercialization of the Product, or (b) fulfill a post-approval study commitment or undertaking imposed by the FDA.
Phase IV Clinical Study means a post-marketing human clinical study for a Product with respect to any Indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.
Phase IV Clinical Study means of such product for the purpose of establishing any clinical study conducted for such product after such product has received Regulatory Approval for marketing in a particular jurisdiction, including trials the principal purpose of which is to (a) continue testing such product to collect information about (i) its safety or efficacy to provide comprehensive data confirming the benefit-risk balance is positive to convert to a standard Regulatory Approval for marketing in broader or various populations, (ii) its long term safety and side effects associated with long term use, or (iii) its use in additional diseases or conditions other than those for which Regulatory Approval was previously granted where the product is likely to be used “off label” in the disease or condition as a result of a similar mechanism of action, (b) obtain or widen reimbursement coverage, (c) improve the product’s competitive position, or (d) improve the standard of care. For clarity, Phase IV Clinical Studies do not include investigator-initiated trials.
Phase IV Clinical Study. Phase IV Clinical Study means a human clinical study initiated in a country in an approved indication after receipt of Regulatory Approval for such indication in such country.
Phase IV Clinical Study means any post-marketing human clinical trial to confirm with statistical significance the safety and efficacy of the Product, whether initiated by a Party or at the request of the FDA, to delineate additional information about a drug’s risks, benefits, and optimal use, including, without limitation, safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of a disease or condition or for indications including (but not limited to) for the treatment of hyperplasia or hormone replacement therapy, or studies of the use of the drug over a longer period of time.
Phase IV Clinical Study means any Clinical Study in an indication for an Eisai Collaboration Product to be conducted after a Regulatory Approval in such indication which was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval or was otherwise conducted for any other purpose, including for medical observation or commercial purposes.
Phase IV Clinical Study. Phase IV Clinical Study means a human clinical study that is conducted post Regulatory Approval and that is not for the purpose of (a) obtaining, maintaining or expanding a Regulatory Approval, or (b) studying the applicable Product for a potential expanded label.