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Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Pharmacy --- Medical

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Science --- Methodology --- AA / International- internationaal --- 303.0 --- Philosophy. --- Science. --- -#SBIB:303H510 --- Natural science --- Science of science --- Sciences --- Philosophical Overview --- Hedonism --- Stoicism --- Overview, Philosophical --- Overviews, Philosophical --- Philosophical Overviews --- Philosophies --- Statistische technieken in econometrie. Wiskundige statistiek (algemene werken en handboeken). --- Methoden sociale wetenschappen: statistische technieken, algemeen --- Methodology. --- Philosophy --- #SBIB:303H510 --- Pharmacy Philosophy --- Pharmacy Philosophies --- Philosophies, Pharmacy --- Philosophy, Pharmacy --- Scientific method --- Logic, Symbolic and mathematical --- Statistische technieken in econometrie. Wiskundige statistiek (algemene werken en handboeken) --- Science - Methodology --- History of science --- Probability theory --- Statistical theories

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Every four minutes, over 50 children under the age of five die. In the same four minutes, 2 mothers lose their lives in childbirth. Every year, malaria kills nearly 1.2 million people, despite the fact that it can be prevented with a mosquito net and treated for less than 1.50.Sadly, this list goes on and on. Millions are dying from diseases that we can easily and inexpensively prevent, diagnose, and treat. Why? Because even though we know exactly what people need, we just can't get it to them. They are dying not because we can't solve a medical problem but because we can't solve a logistics

Pharmaceutical policy --- Drugs --- Medical care --- World health. --- Global health --- International health --- Public health --- Medical geography --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Pharmacy --- Drug policy --- Drugs and state --- Pharmacy and state --- State and drugs --- State and pharmacy --- Medical policy --- International cooperation --- Government policy --- World health --- E-books

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Pharmaceuticals are an essential component of health care. But for many people in low- and middle-income countries, access to the medicines they need to prevent or treat severe illnesses is limited. Typical problems are lack of availability, costs that exceed the individual's purchasing power or lack of competent "agents" - health workers that are well trained to give the correct advice on which medicines to take. Pharmaceutical policy is the part of health policy that aims at addressing these problems and increasing access to safe, effective and affordable medicines for all patients. There ar

Pharmaceutical policy. --- Drug Industry --- Developed Countries. --- Government Regulation. --- Health Plan Implementation. --- Health Policy --- organization & administration. --- economics. --- Medical policy. --- Health care policy --- Health policy --- Medical care --- Medicine and state --- Policy, Medical --- Public health --- Public health policy --- State and medicine --- Science and state --- Social policy --- Drug policy --- Drugs --- Drugs and state --- Pharmacy --- Pharmacy and state --- State and drugs --- State and pharmacy --- Medical policy --- Government policy --- Health Plan Implementation --- organization & administration --- economics --- Developed Countries --- Government Regulation

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Pharmacogenetics helps us understand the relationship between an individual’s genetic make-up and the way medicines work for each person. This book reviews the use of pharmacogenetics across all stages of the health innovation cycle from research through to uptake by doctors and patients. It focuses on how to optimise the use of pharmacogenetics to deliver effective innovations for public health, and design policies that enhance their economic and social benefits. The book argues for large-scale studies to validate the biomarkers that underpin pharmacogenetics and policies to share the cost and risk of using  pharmacogenetics to improve the use of existing  medicines. Governments and others need to align regulatory, reimbursement and other incentives and work  with industry to measure better the impacts of pharmacogenetics. Health systems need to take positive steps to adapt to the use of pharmacogenetics and ensure that health professionals receive adequate training.

Behavior genetics. --- Pharmaceutical industry --Technological innovations. --- Pharmacogenetics. --- Pharmacogenetics --- Pharmaceutical industry --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Technological innovations --- Technological innovations. --- Pharmacology --- Genetic aspects --- Biochemical genetics --- Medical innovations