Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA)

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Author :
Publisher : GRIN Verlag
ISBN 13 : 3346777863
Total Pages : 106 pages
Book Rating : 4.3/5 (467 download)

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Book Synopsis Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA) by : Shailaja Pashikanti

Download or read book Regulatory Guidelines for Registration and Submission Criteria in South Africa (SAHPRA) written by Shailaja Pashikanti and published by GRIN Verlag. This book was released on 2022-12-09 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt: Document from the year 2022 in the subject Pharmacology, Andhra University (A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam), course: Pharmaceutical Regulatory Affairs, language: English, abstract: This publication examines the regulatory guidelines for registration and submission criteria in South Africa. South African Health Products Regulatory Authority (SAHPRA) is the entity of the national department of health (NDoH) launched in February 2017. It replaced the former Medicines Control Council (MCC) as well as Directorate of Radiation Control (DRC) that regulated medical devices in-vitro diagnostic tests and devices, radiation-emitting products and devices used in health care and industry. Due to several drawbacks of MCC such as becoming dependent on external expertise, it eventually lead to lack of effective performance management contracts and unsustainable mechanism for submission of evaluation reports, SAHPRA is established. An application for registration of medicines should be submitted for evaluation and approval through SAHPRA guidelines which are applicable to human medicines including biological and complimentary medicines. So SAHPRA adopted EU variation guidelines for quality and bio equivalence requirements for new registration and variations that are submitted by applicant in eCTD format established by the International Council for Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Submission of applications are done by following South Africa eCTD validation criteria in module 1 of regional information provided by South Africa.

Pharmaceutical Practice E-Book

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Author :
Publisher : Elsevier Health Sciences
ISBN 13 : 0702041874
Total Pages : 663 pages
Book Rating : 4.7/5 (2 download)

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Book Synopsis Pharmaceutical Practice E-Book by : Arthur J. Winfield

Download or read book Pharmaceutical Practice E-Book written by Arthur J. Winfield and published by Elsevier Health Sciences. This book was released on 2009-07-21 with total page 663 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, pharmacoeconomics, and medicines management. Features useful appendices on medical abbreviations, pharmaceutical Latin terms, weights and measures, and presentation skills. This is a core text for pharmacy practice and dispensing modules of the pharmacy curriculum Covers key exam material for essential review and test preparation Features a user-friendly design with clear headings, chapter summaries, helpful boxes, and key points Text restructured with 14 new or radically revised chapters. All text revised in light of current pharmaceutical practice. New design using two colours.

Higher Education Opportunity Act

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Author :
Publisher :
ISBN 13 :
Total Pages : 432 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Higher Education Opportunity Act by : United States

Download or read book Higher Education Opportunity Act written by United States and published by . This book was released on 2008 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Intellectual Property Law and Access to Medicines

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Author :
Publisher : Routledge
ISBN 13 : 1000398706
Total Pages : 522 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Intellectual Property Law and Access to Medicines by : Srividhya Ragavan

Download or read book Intellectual Property Law and Access to Medicines written by Srividhya Ragavan and published by Routledge. This book was released on 2021-07-28 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Travel Medicine - Series Ⅰ

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Author :
Publisher : MDPI
ISBN 13 : 303897952X
Total Pages : 68 pages
Book Rating : 4.0/5 (389 download)

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Book Synopsis Travel Medicine - Series Ⅰ by : Larry Goodyer

Download or read book Travel Medicine - Series Ⅰ written by Larry Goodyer and published by MDPI. This book was released on 2019-05-09 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of papers describes the recent development of travel health and vaccination services delivered by pharmacists. It is the first dedicated collection of its type and provides a template for the continued growth of pharmacy practice in this area. The articles examine and report on aspects of such services in the UK, US, Canada, Australia, Switzerland, and South Africa, which will provide useful insight for those in other countries developing such pharmacy-based services.

Pain Management and the Opioid Epidemic

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Author :
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine

Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

The National Health Act - A Guide

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Author :
Publisher : Brian Honermann
ISBN 13 :
Total Pages : 225 pages
Book Rating : 4./5 ( download)

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Book Synopsis The National Health Act - A Guide by :

Download or read book The National Health Act - A Guide written by and published by Brian Honermann. This book was released on with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Manufacturing Handbook

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Publisher : John Wiley & Sons
ISBN 13 : 0470259825
Total Pages : 857 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Pharmaceutical Manufacturing Handbook by : Shayne Cox Gad

Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-04-04 with total page 857 pages. Available in PDF, EPUB and Kindle. Book excerpt: With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Global Regulations of Medicinal, Pharmaceutical, and Food Products

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Author :
Publisher : CRC Press
ISBN 13 : 1040044824
Total Pages : 373 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Global Regulations of Medicinal, Pharmaceutical, and Food Products by : Faraat Ali

Download or read book Global Regulations of Medicinal, Pharmaceutical, and Food Products written by Faraat Ali and published by CRC Press. This book was released on 2024-07-05 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively. Features: Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently. Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent. Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis. Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.

Traditional and Indigenous Knowledge for the Modern Era

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Publisher : CRC Press
ISBN 13 : 135198179X
Total Pages : 357 pages
Book Rating : 4.3/5 (519 download)

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Book Synopsis Traditional and Indigenous Knowledge for the Modern Era by : David R. Katerere

Download or read book Traditional and Indigenous Knowledge for the Modern Era written by David R. Katerere and published by CRC Press. This book was released on 2019-09-05 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: While there is talk of the Fourth Industrial Revolution, old and new challenges bedevil the world – climate change, nutrition, and health poverty being at the top of the list. In seeking solutions to these and other problems which afflict the modern era, it is worthwhile to look into our collective past, to the traditions and knowledges of our ancestors. Such knowledge continues to exist in many parts of the world, though now marginalized by homogenous, Eurocentric ontolology and epistemology. This book presents a compilation of reviews, case studies, and primary research attempting to locate the utility of traditional and Indigenous Knowledges in an increasingly complex world. It assembles chapter authors from across the world to tackle topics ranging from traditional knowledge-based innovations and commercialization, traditional medicine systems as practiced around the world, ethnoveterinary practices, and food innovation to traditional governance and leadership systems, among others. This book is an important resource for policymakers; scholars and researchers of cultural studies, leadership, governance, ethnobotany, anthropology, plant genetic resources and technology innovation; and readers interested in the history of knowledge and culture, as well as cultural activists and political scientists. Features: Unique combination of social science and anthropological aspects with natural science perspectives Includes summaries aimed at policymakers to immediately see what would be relevant to their work Combines case studies illuminating important lessons learned with reviews and primary data Multidisciplinary in the scope of the topics tackled and assemblage of contributors Global footprint with contributions from Africa, Europe, North America, Asia, and the West Indies David R. Katerere, Department of Pharmaceutical Sciences, Tshwane University of Technology, South Africa Wendy Applequist, William L. Brown Center, Missouri Botanical Garden, St Louis, Missouri Oluwaseyi M. Aboyade, Department of Pharmaceutical Sciences, Tshwane University of Technology, South Africa and Nutritica SA, The Innovation Hub, Pretoria, South Africa Chamunorwa Togo, The Innovation Hub, Pretoria, South Africa

Pharmacist Initiated Therapy

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Publisher : Juta and Company Ltd
ISBN 13 : 9780702130090
Total Pages : 316 pages
Book Rating : 4.1/5 (3 download)

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Book Synopsis Pharmacist Initiated Therapy by : Anita Dekker

Download or read book Pharmacist Initiated Therapy written by Anita Dekker and published by Juta and Company Ltd. This book was released on 1993-12-31 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the clinically relevant information relating to more than 90 different ailments in such a way that pharmacists should be able to apply this knowledge responsibly in their own practices.

Current Commercial Cases 2006

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Publisher : The Law Publisher CC
ISBN 13 : 1920569340
Total Pages : 125 pages
Book Rating : 4.9/5 (25 download)

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Book Synopsis Current Commercial Cases 2006 by :

Download or read book Current Commercial Cases 2006 written by and published by The Law Publisher CC. This book was released on with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Compendium of Key Documents Relating to Human Rights and HIV in Eastern and Southern Africa

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Author :
Publisher : PULP
ISBN 13 : 0980265894
Total Pages : 328 pages
Book Rating : 4.9/5 (82 download)

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Book Synopsis Compendium of Key Documents Relating to Human Rights and HIV in Eastern and Southern Africa by :

Download or read book Compendium of Key Documents Relating to Human Rights and HIV in Eastern and Southern Africa written by and published by PULP. This book was released on 2008 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: The compendium of key Documents relating to human rights and HIV in Eastern and Southern Africa provides instrument, policies and cases which are relavant to HIV/AIDS.

A Comprehensive and Practical Guide to Clinical Trials

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Publisher : Academic Press
ISBN 13 : 0128047305
Total Pages : 212 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis A Comprehensive and Practical Guide to Clinical Trials by : Delva Shamley

Download or read book A Comprehensive and Practical Guide to Clinical Trials written by Delva Shamley and published by Academic Press. This book was released on 2017-06-07 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. - Describes the entire clinical trial management process from start to finish in a step-by-step guide - Provides best practice elements, including case studies, practical examples, activities, and checklists

Manual of Commercial Methods in Clinical Microbiology

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 1119021863
Total Pages : 652 pages
Book Rating : 4.1/5 (19 download)

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Book Synopsis Manual of Commercial Methods in Clinical Microbiology by :

Download or read book Manual of Commercial Methods in Clinical Microbiology written by and published by John Wiley & Sons. This book was released on 2016-03-28 with total page 652 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Manual of Commercial Methods in Clinical Microbiology 2nd Edition, International Edition reviews in detail the current state of the art in each of the disciplines of clinical microbiology, and reviews the sensitivities, specificities and predictive values, and subsequently the effectiveness, of commercially available methods – both manual and automated. This text allows the user to easily summarize the available methods in any particular field, or for a specific pathogen – for example, what to use for an Influenza test, a Legionella test, or what instrument to use for identification or for an antibiotic susceptibility test. The Manual of Commercial Methods in Clinical Microbiology, 2nd Edition, International Edition presents a wealth of relevant information to clinical pathologists, directors and supervisors of clinical microbiology, infectious disease physicians, point-of-care laboratories, professionals using industrial applications of diagnostic microbiology and other healthcare providers. The content will allow professionals to analyze all commercially available methods to determine which works best in their particular laboratory, hospital, clinic, or setting. Updated to appeal to an international audience, The Manual of Commercial Methods in Clinical Microbiology, 2nd Edition, International Edition is an invaluable reference to those in the health science and medical fields.

Manual of Nursing

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Publisher : Juta and Company Ltd
ISBN 13 : 9780702120459
Total Pages : 912 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Manual of Nursing by : M. E. Vlok

Download or read book Manual of Nursing written by M. E. Vlok and published by Juta and Company Ltd. This book was released on 1992-12 with total page 912 pages. Available in PDF, EPUB and Kindle. Book excerpt: The two-volume "Manual of Nursing" is a comprehensive and up-to-date work on the nursing profession in South Africa. It covers the whole nursing curriculum and broadens the student's scope of knowledge by discussing subjects not included in midwifery, critical care nursing, community nursing and psychiatric nursing. Easy referencing ensures that the set (encapsulating the integrated nursing course) is of immediate and practical use. This work discusses medical and surgical conditions from a nursing perspective. Volume One introduces certain basics of nursing theory and practice and it includes a section dealing with nursing-related services.

A History of Therapeutic Goods Regulation in Australia

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Author :
Publisher :
ISBN 13 : 9780980422900
Total Pages : 170 pages
Book Rating : 4.4/5 (229 download)

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Book Synopsis A History of Therapeutic Goods Regulation in Australia by : John McEwan

Download or read book A History of Therapeutic Goods Regulation in Australia written by John McEwan and published by . This book was released on 2007 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: