51 Vigilance of Natural Health Products Mano Murty, MD, CCFP, FCFP,* Kevin Bernardo, ND, BHsc,* and Alison Ingham, PhD** *Marketed Health Products Directorate, Health Canada (contact: mano_murty@hc-sc.gc.ca) **Natural Health Products…
40 Organization of a Typical Drug Safety Department This description covers a “standard” safety department found in a large or midsized (multinational) pharmaceutical company. Some functions and divisions do not…
47 Business Partners and Exchange of Safety Data Development costs for a new chemical entity from creation to marketing range from $400 million to $2 billion (depending on how one…
21 The United States Food and Drug Administration (FDA) and MedWatch The “granddaddy” of drug safety “regulatory agencies” dates back to eighteenth-century Japan, when the eighth shogun, Yoshimune Tokugawa (1716–1745),…
30 Risk: What Is It? Risk Management and Assessment, Risk Evaluation and Minimization Systems (REMS), and Risk Management Plans (RMPs) Risk is a broad concept and applies to everything in…
48 Audits and Inspections The U.S. Food and Drug (FDA), the European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), Health Canada, and many other…
24 United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is the Competent Authority that handles medicinal products, blood products,…
42 The Safety Department’s Role in Clinical Research, Marketing and Sales, Labeling, Regulatory, Due Diligence, and Legal Issues Clinical Research The clinical research (or medical research) department is the section…
19 Signals and Signaling in the Context of Risk Management Enormous efforts are made, in terms of people, time, cost, and technology, to collect AE data in companies, governments, and…
