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 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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Examples of Scientific Advice in a sentence

  • The Scientific Advice pertained to quality, non-clinical and clinical aspects of the dossier.

  • Researchers often do not allocate enough time and resources and also lack specific relevant know-how to develop strategies enabling successful regulatory Scientific Advice procedures.

  • The Scientific Advice pertained to non-clinical and clinical aspects of the dossier.

  • The Scientific Advice pertained to clinical aspects of the dossier.

  • In 1994, the Biological Objectives Working Group of the Pacific Scientific Advice Review Committee (PSARC) identified three biological objectives for management of Pacific Region fish and invertebrate stocks (Rice et al.

  • Hughes noted the large percentage for “Surface Water Management”.

  • Responsibilities: • Review of CMC data required for regulator y submissions, including MAA , responses to consolidated questions, Scientific Advice and CTA applications for Elan’s biotechnological products.

  • Scientific advice The MAH did not seek Scientific Advice at the CHMP.

  • Ministers have a duty to give fair consideration and due weight to informed and impartial advice from civil servants, as well as to other considerations and advice in reaching policy decisions, and should have regard to the Principles of Scientific Advice to Government.

  • Lynn Frewer & Brian Salter, Public Attitudes, Scientific Advice, and the Politics of Regulatory Polices: The Case of BSE, 29 Sci.


More Definitions of Scientific Advice

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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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 issuance of any prescription or follow-up prescription.

  • Medical information means any individually identifiable information, in electronic or physical form, regarding the individual’s medical history or medical treatment or diagnosis by a health care professional.

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • DRS Advice means the notification produced by the DRS system evidencing ownership of the Warrants or Common Shares, as the case may be;

  • Department of Information Technology means the New Mexico Department of Information Technology which is responsible for operating the data center and all communications related items.

  • Information Technology means computers, software, databases, firmware, middleware, servers, workstations, networks, systems, routers, hubs, switches, data communications lines, and all other information technology equipment and associated documentation.

  • Information Technology Resources means agency budgetary resources, personnel, equipment, facilities, or services that are primarily used in the management, operation, acquisition, disposition, and transformation, or other activity related to the lifecycle of information technology; acquisitions or interagency agreements that include information technology and the services or equipment provided by such acquisitions or interagency agreements; but does not include grants to third parties which establish or support information technology not operated directly by the Federal Government. (0MB M-15-14)

  • Information Technology (IT means data processing, telecommunications, and office systems technologies and services:

  • Sensitive Data means information that is protected against unwarranted disclosure, to include Personally Identifiable Information (PII), Protected Health Information (PHI) or other private/confidential data, as specifically determined by the State. Sensitive Data includes information about an individual that (1) can be used to distinguish or trace an individual‘s identity, such as name, social security number, date and place of birth, mother‘s maiden name, or biometric records; (2) is linked or linkable to an individual, such as medical, educational, financial, and employment information; (3) falls within the definition of “personal information” under Md. Code Ann., Com. Law § 14-3501(d); or (4) falls within the definition of “personal information" under Md. Code Ann., State Govt. § 10-1301(c).

  • Suggestions means all suggested improvements to the Service Offerings that you provide to us.

  • Authority's Confidential Information means all Personal Data and any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, know-how, personnel, and suppliers of the Authority, including all IPRs, together with all information derived from any of the above, and any other information clearly designated as being confidential (whether or not it is marked "confidential") or which ought reasonably be considered to be confidential;

  • Independent professional advice means advice of an attorney, certified public accountant, actuary, or other licensed professional adviser.

  • Licensed professional means a professional registered in the Commonwealth of Virginia pursuant to Article 1 (§ 54.1-400 et seq.) of Chapter 4 of Title 54.1 of the Code of Virginia. For purposes of these Standards and Specifications a licensed professional is one that is certified by DPOR as an Architect, Professional Engineer, Land Surveyor, or Landscape Architects.

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Information technology services means services designed to do any of the following:

  • Legal Advice as used herein shall be solely and exclusively limited to the advice provided by legal counsel stating legal rights, duties, liabilities and defenses and shall not include factual information or the formulation or analysis of business strategy.

  • input means any goods other than capital goods used or intended to be used by a supplier in the course or furtherance of business;

  • Educational data means data maintained by the school district which relates to a student.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Collaboration has the meaning set forth in Section 2.1.

  • Professional Technologist means a person holding registration as Professional Engineering Technologist in terms of the Engineering Profession Act, 2000.