Post-Marketing Study definition

Post-Marketing Study means a non-human or human clinical study of a Licensed Product initiated after receipt of Regulatory Approval for such Licensed Product in a country or territory, that is required by the Regulatory Authority in such country or territory to maintain the Regulatory Approval for such Licensed Product in such country or territory, but excluding any Supplemental Study.
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Post-Marketing Study means a product support clinical trial of a Licensed Product that is commenced after receipt of Regulatory Approval in the country where such trial is conducted. Post-Marketing Studies may include epidemiological studies, modeling and pharmacoeconomic studies, “post-marketing surveillance trials” and investigator-sponsored clinical trials studying a Licensed Product.
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Post-Marketing Study means a post-marketing human clinical trial for a Licensed Product commenced after receipt of a Regulatory Approval in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the Product. Phase IV Clinical Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies, investigator-sponsored clinical trials of Product and post-marketing surveillance studies.
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Examples of Post-Marketing Study in a sentence

  • Upon the Parties’ mutual agreement on the Study Plan, the Development Plan shall be amended to add such Study Plan, and the study described therein will be designated as a Joint Post-Marketing Study, the costs of which will be shared in accordance with Section 3.7(b).

  • This surveillance will be conducted in compliance with the Ministerial Ordinance on Good Post-Marketing Study Practice (GPSP) and relevant regulatory requirements.

  • Newspaper ads and listing are also frequently mentioned (by 28% of those aware).

  • This surveillance will be conducted in compliance with the ministerial ordinance on Good Post-Marketing Study Practice (GPSP) and related regulatory requirements.

  • Personal and health information is required in order to determine eligibility and, in the event you are approved to receive drug benefits, to maintain eligibility, process payments and conduct the Alberta Post-Marketing Study Addressing ENBREL/HUMIRA/KINERET/REMICADE (“Study”).

  • In relation to the Territory, Astellas shall [***] for any Post-Marketing Study and shall present it to the JDC [***].

  • CMBs are occasionally offered by the Treasury Department to meet short-term financing needs, with their maturities ranging from one-day to approximately one-year.

  • This is the subject of the Post-Marketing Study Requirement (see section 12 below).

  • BSC’s Urology & Women’s Health Safety Team will perform medical safety functions for the Business’ Prolieve Post-Marketing Study (A Multi-Center, Post-Marketing Device Study to Assess the Long Term Safety and Efficacy of the Study Device in Patients with Benign Prostatic Hyperplasia (BPH)), including: • Complaint processing; • Independent Medical Reviewer management; and • Participate in Clinical Trial Safety Review meetings.

  • With the recommended Good Post-Marketing Study Practice (GPSP) and the binding Good Vigilance Practice (GVP), a Marketing Authorization Holder (MAH) must permanently collect information about their pharmaceutical or biopharmaceutical product, including information from the Internet.


More Definitions of Post-Marketing Study

Post-Marketing Study means any study conducted with respect to a Product after submission of an application for Regulatory Approval for such Product, 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. For clarity, Post-Marketing Studies shall not include studies designed to determine the efficacy of a drug for an Indication for which Regulatory Approval has not been granted or studies that are otherwise required to obtain or maintain Regulatory Approval.
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Post-Marketing Study means any study conducted by or for Takeda in the Takeda Territory with respect to a Vaccine after submission of an application for Regulatory Approval for such Vaccine, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a Vaccine’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 Vaccine in other patient populations or other stages of the disease, or studies of the use of the Vaccine over a longer period of time, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.
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Post-Marketing Study has the meaning set forth in the Master Agreement.
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Post-Marketing Study means any study conducted by or for Zai in the Licensed Territory with respect to the Licensed Product after submission of a Regulatory Approval Application for the Licensed Product, 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, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.
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Related to Post-Marketing Study

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Study means a Phase I Study, Phase II Study (including a Phase II(a) and Phase II(b) Study), Phase III Study or Post-Approval Studies, as applicable.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Competing Product means […***…].

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Regulatory Approval means any and all approvals (including price and reimbursement approvals, if required prior to sale in the applicable jurisdiction), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a particular Licensed Product in the applicable jurisdiction.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.