PPT-Clinical Trials and Testing of Veterinary Medicinal Products in Ireland
Author : jesiah | Published Date : 2024-09-09
Jane Lenehan Scientific Animal Protection Manager acting HPRA Veterinary Medicines Information Day 13 June 2018 Hilton Hotel Dublin Airport Todays talk Background
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Clinical Trials and Testing of Veterinary Medicinal Products in Ireland: Transcript
Jane Lenehan Scientific Animal Protection Manager acting HPRA Veterinary Medicines Information Day 13 June 2018 Hilton Hotel Dublin Airport Todays talk Background Application process. Director . International Programs. Center for Veterinary Medicine. U.S. Food and Drug Administration. Governance of Veterinary Medicinal Products: Need to Leverage Resources. . Authorization of veterinary medicines around the world almost universally requires some sort of premarket clearance or licensing and is based in legislation and regulation. Presented by: Candice Beathard, PhD. December 15, 2015 . Background: History of Cannabis as Medicine . Dates back to 2727B.C. in China. 1. In U.S…. 1850: cannabis tinctures patented. 2. . 1963: chemical structure of cannabis identified. Workshop. Edel Ryan / Andrew Hall. 12. th. April 2018. Brexit ? What is all this about ? . . Brexit, ˈ. brɛksɪt. ’. noun: . Brexit. ; noun: . Brixit. a term for the potential or hypothetical departure of the United Kingdom from the European Union.. Page 2 of 7 EMEA 2005 TABLE OF CONTENTS 1 INTRODUCTION3 11 Regulatory framework3 12 Scope3 13 Need to issue guidance on this emerging issue3 14 Purpose3 2 BASIC PRINCIPLES3 21 GS1 2017 GS1 2017The views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the US Food and Drug Administration GS Director . International Programs. Center for Veterinary Medicine. U.S. Food and Drug Administration. Governance of Veterinary Medicinal Products: Need to Leverage Resources. . Authorization of veterinary medicines around the world almost universally requires some sort of premarket clearance or licensing and is based in legislation and regulation. Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. Cell-based Medicinal ProductsCellTherapyProductsTissueEngineering Products Existing legislation and guidance concerning CBMPsRegulation1394/2007/ECDirective2001/83/EC, AnnexI, PartIV (underrevision)Di (CHMP) GUIDELINE ON FOLLOW-UP OF PATIENTS ADMINISTERED WITH GENE THERAPY MEDICINAL PRODUCTS AGREED BY GENE THERAPY WP April 2008 AGREED BY PHARMACOVIGILANCE WP March 2008 ADOPTION BY CHMP FOR REL End of consultation (deadline for comments)31 May 2012 Agreed by BMWP Adopted by CHMP21 February 2013 Date for coming into effect01 September 2013 Keywords Follicle stimulating hormone (FSH), similar Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . Public-Private Partnership. Co-founded by Duke University & FDA . Involves all stakeholders. Approx. 80+ members. Participation of 400+ more orgs. MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Learning Objectives. Summarise regulatory changes and other issues that need to be considered for the legal use and supply of medicinal cannabis . Discuss the Commonwealth and state specific requirements to prescribe and dispense medicinal cannabis in Australia. Dr. Haider Raheem. Formulary Systems . Background. A formulary is a continually updated list of medications and related information, representing the clinical judgement of physicians, pharmacists and other experts in the diagnosis, prophylaxis or treatment of disease and promotion of health. A formulary includes, but is not limited to, a list of medications and medication-associated products or devices, medication-use policies, important ancillary drug information, decision-support tools, and organizational guidelines..
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