M4E(R2) - European Medicines Agency
and interpretation of these findings together with any other relevant information (e.g., pertinent animal data or product quality issues that may have clinical implications). The Clinical Overview is primarily intended for use by regulatory agencies in the review of the clinical section of a marketing application.
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9 December 2013 . EMA/816292/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1)
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harmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product
There is no expectation that existing herbal medicinal products on the market will be affected by this guideline, with the exception of traditional herbal medicinal products for human use that were already
ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers EMA/CHMP/ICH/468930/2015 Page 2/37
To measure regulatory progress in a meaningful and credible way, governments will need both indicators to measure relevant outcomes of concern and research designs to support inferences about the extent to which a regulation or regulatory policy under evaluation has actually caused any change in the measured outcomes.
Roles and Responsibilities around Regulatory Compliance Management 06 A view of the Regulatory Universe of key Industries 09 Conclusion 10 Contacts 11. 03 Introduction ... emerging legislation relevant to its business and ensure that risks that may arise from the compliance requirements are well understood by the board and
Regulatory Expectations Alyson Karesh, M.D. ... relevant information, as available, included. 45. Pediatric Study Plan: Contents 1) Overview - Disease Condition 2) Overview - Drug/Biologic
The 38 Principles need to be practically implemented under the relevant legal framework to achieve the Objectives of regulation described above. The Principles are grouped into ... 4 The Regulator should adopt clear and consistent regulatory processes. 5 The staff the Regulator should of observe the highest professional standards,
perts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole. (b) To promote that open exchange, each agency, consistent with Executive Order 12866 and other applicable legal requirements, shall endeavor to provide the public with an opportunity to participate in the regulatory process.
Regulation 76 requires a relevant authority to issue a schedule of essential safety provisions (ESPs) when-- Granting a building rules consent - Assigning a change of building classification - A building owner applies for one to be issued - Issuing any other certification for building work that complies with the Building Rules 29/06/2015
such circumstances, this ASAE is relevant only to the portion of the engagement relating to assurance on compliance. 12. If multiple standards are applicable to the assurance engagement, the assurance practitioner applies, in addition to ASAE 3000, either: (a) If the engagement can be separated into parts, the standard relevant to each part of the
4 1. Introduction Regulation refers to “controlling human or societal behaviour by rules or regulations or alternatively a rule or order issued by an executive authority or regulatory agency of a government and having the force of law”.1 Regulation covers all activities of private or public behaviour that may be detrimental to societal or governmental interest but its scope varies …