Scientific Advice definition

Scientific Advice means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
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Scientific Advice means any report of the advice provided by EMA to medicine developers on the most appropriate way to generate robust evidence on a medicine’s benefits and risks.
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Scientific Advice means Scientific Advice from CHMP concerning the requirements for a MA for the Product for the First Indication within the EU;
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Examples of Scientific Advice in a sentence

  • Licensee shall have the right to perform a Scientific Advice with the applicable Regulatory Authorities in the Licensee Territory.

  • The Role of Scientific Advice in Democracies, Cambridge: MIT Press ▇▇▇▇▇▇, ▇.

  • In line with the Opinion of the Scientific Advice Mechanism (▇▇▇)13 as regards light duty vehicles, and the recommendation of the European Parliament following its inquiry into emission measurements in the automotive sector, it is appropriate also in the case of heavy-duty vehicles to put in place a mechanism to assess the real-world representativeness of the CO2 emissions and energy consumption values determined pursuant to Regulation (EU) 2017/2400.

  • Rapporteurs Mtg - 2 docs Scientific Advice - 8 docs FDA: Meeting correspondence log from BLA m1.Also, discussion with FDA in Jan 09 to discuss advanced cancer pre- BLA submission.

  • Final Version October 2010 Project Specification Form – Scientific Advice programme Title Provision of scientific advice to [company name] on their product [product name or code name] Synopsis of the technical issue [Product name or code name] [Therapeutic area] [Class of drug] [Stage of development] The company’s briefing book on the product is provided with this spec.

  • Revance shall provide Mylan with a copy of Revance’s meeting minutes from the FDA Scientific Advice Meeting for review and comment prior to finalizing such minutes.

  • Further, Revance shall provide Mylan with the FDA’s final minutes from the FDA Scientific Advice Meeting (the “FDA Minutes”) within two (2) Business Days of Revance’s receipt of such minutes.

  • For the purposes of their work on a Scientific Advice project, the experts should be considered as “expert advisors” under the terms of this policy.

  • Mylan shall have two (2) or more representatives from Mylan attend, assist in the preparation for, and participate in the FDA Scientific Advice Meeting for the Product and any meeting with Regulatory Authorities held by Revance related to the INDs filed by Revance for the Product in the Territory, subject to the confidentiality provisions set forth under Article 12 below.

  • The role of the supplier is to source and manage the external expertise required by each advice project in NICE’s Scientific Advice programme.


More Definitions of Scientific Advice

Scientific Advice means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device.”.
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Scientific Advice means the procedures established by EMEA Regulation (EC) No 726/2004, or any subsequent regulations of the EMEA, providing a mechanism to obtain advice regarding development of new therapies.
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Related to Scientific Advice

  • Competent and reliable scientific evidence means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Feedback means input regarding the SAP Products, services, business or technology plans, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the SAP Products and/or services, or input as to whether Partner believes SAP’s development direction is consistent with their own business and IT needs.

  • Licensed professional counselor means a counselor licensed by a member state, regardless of the title used by that state, to independently assess, diagnose, and treat behavioral health conditions.

  • Medical Advice means any consultation or advice from a Medical Practitioner including the issue of any prescription or follow up prescription.