Scientific Advice definition

Scientific Advice means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
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.
Scientific Advice means Scientific Advice from CHMP concerning the requirements for a MA for the Product for the First Indication within the EU;

Examples of Scientific Advice in a sentence

  • In line with the Opinion of the Scientific Advice Mechanism (XXX)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.

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

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

  • Standard project specification for input by external experts into NICE’s Scientific Advice programme 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.

  • 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.

  • The Code of Practice for Scientific Advisory Committees and the Principles of Scientific Advice to Government provide more detailed guidance on the operation of scientific advisory committees (SACs) and their relationship with their sponsor Departments.


More Definitions of Scientific Advice

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.

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 information about a consumer's medical or mental health treatment or diagnosis by a health care professional.

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

  • 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 computer hardware, software and networks;

  • 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;

  • Information Technology Systems means all information technology systems, Software, computers, workstations, databases, routers, hubs, switches, networks and other information technology equipment used or held for use in, or otherwise relating to, the 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.