Non-Interventional Studies definition

Non-Interventional Studies means studies in which results from the treatment of patients with pharmaceutical products are analysed with epidemiological methods. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Non-Interventional Studies means studies and activities to gain more knowledge about any Compound or Product and the potential indications for which such Compound or Product may be efficacious, including epidemiological studies, natural history studies, real world evidence studies based on registries or databases, predictive modeling or pharmacoeconomic studies, burden of illness studies, and post-marketing surveillance studies (but not Phase 4 Clinical Trials).
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Non-Interventional Studies means studies in which results from the treatment of patients with pharmaceutical products are analysed with
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Examples of Non-Interventional Studies in a sentence

  • Non-Interventional Studies that are subject to National Contract Value Review must use an unmodified version of the Finance Schedule generated by the interactive Costing Tool (iCT).

  • Non-Interventional Studies The Parties agree to exchange information on a study level to indicate if the NIS uses primary or secondary data collection.

  • CMS will inform BIOCODEX of any: - Clinical Studies - Post Authorization Interventional & Non-Interventional Studies - Investigator Initiated Sponsored Studies conducted with the Product by CMS in the Territory.

  • Each Party agrees to exchange safety data with the other Party, regardless of whether or not the Product was used in accordance with the authorised Summary of Product Characteristics (SPC) and/or any other conditions laid down for marketing of the Product in accordance with applicable legal requirements as follows: Adverse Drug Reactions from Non-Interventional Studies (NIS) with primary data collection that are not actively collected, should be reported on the same expedited basis as spontaneous reports.

Related to Non-Interventional Studies

  • Early intervention means activities that take place with high−risk individuals, families or populations with the goal of averting or interrupting the further progression of problems asso- ciated with substance use or abuse. These activities may include problem identification and resolution, referral for screening, spe- cialized education, alternative activities development, social pol- icy development, environmental change, training and devel- opment of risk reduction skills.

  • Early intervention services means individual programmes for children with developmental delays or disabilities, or children at risk of being developmentally delayed or of having a disability, aged 0 to 6 years, aimed at providing assistance to the child and its family in the areas of physical, emotional, social and educational needs.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Intervention means any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident;