Regulatory compliance Books
Pharmaceutical Press Good Pharmacovigilance Practice Guide
Book SynopsisPharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines. This text provides practical advice about achieving an appropriate system of pharmacovigilance.Trade Review'This is an easy-to-read, practical guide that navigates relevant pharmacovigilance legislation and guidance. It is a valuable single reference for an array of information.'Joshua J Gagne PharmD MS, The Annals of Pharmacotherapy, Volume 43, May 2009 -- Joshua J Gagne * The Annals of Pharmacotherapy *'This book provides valuable insight to the agency's (MHRA) expectations. Those whose primary role lies outside the area of pharmacovigilance are very likely to benefit from the book because it should help them to better understand the commitments the organization is making to maximise product safety.'Michael R Jacobs, BS PharmD, Doody's Notes, 27th February 2009 -- Michael R Jacobs * Doody's Notes *Table of Contents1. EEA Qualified Person Responsible for Pharmacovigilance; 2. Management of Pharmacovigilance Data; 3. Spontaneous Case Processing; 4. Literature Searching; 5. Periodic Safety Update Reports; 6. Evaluation of Safety Data; 7. Risk Management Plans; 8. Reference Safety Information; 9. Quality Management System; 10. Interactions Between Pharmacovigilance and Other Functions; 11. Contracts and Agreements; 12. Safety Reporting for Clinical Trials.
£34.20
Pharmaceutical Press Pharmacy and Medicines Law in Ireland
Book SynopsisOpening with a detailed account of the historical development of Irish pharmacy and medicines law, this practical textbook covers all aspects of current pharmacy and medicines law in Ireland, including the landmark Pharmacy Act of 2007.Trade Review"Irish pharmacists, pharmacy students and those coming to practice in Ireland from other countries, this new text will also be a valuable reference source for lawyers, government bodies and anyone who wants to know more about the regulatory framework for pharmacists and medicinal products in Ireland." Evening Echo, Monday May 23, 2011 * Evening Echo *Table of Contents1. Introduction 2. Sources of Irish Law 3. Historical development of medicines and pharmacy law 4. Placing medicines on the market 5. Manufacturing and wholesaling of medicines 6. Advertising of medicines 7. Prescription and control of supply of medicines 8. Misuse of Drugs Acts and Regulations 9. Poisons Acts and Regulations 10. Veterinary medicines 11. Methylated spirits legislation 12. The Pharmacy Act 13. Pharmacy Act-regulations and rules 14. The pharmacy disciplinary system 15. Liability of community pharmacists in negligence and for defective products
£36.00
IAEA Application of the Concept of Clearance
Book SynopsisProviding recommendations on the application of the concept of clearance for materials, objects and buildings that are to be released from regulatory control, this publication supports the application of the relevant requirements of IAEA Safety Standards Series No. GSR Part 3. It includes detail on the regulatory framework for clearance; the clearance process; the derivation of clearance levels; the application of clearance to solid materials, liquids and gases; generic clearance and specific clearance using activity concentration and surface contamination clearance levels. It also provides recommendations on the involvement of interested parties. Written for governmental officials, and those working for regulatory bodies and operating organizations, this publication will also be of interest to technical service providers in radiation protection. The recommendations provided are applicable to facilities that use, manufacture, process or store radioactive material, such as nuclear power plants, research reactors, other nuclear fuel cycle facilities, facilities for the management of radioactive waste, industrial plants, medical facilities, research facilities, educational facilities and accelerators. The recommendations in this publication also apply to industries processing materials containing radionuclides of natural origin and to the management of material originating from remediation activities or from post- emergency situations.
£53.20
IAEA Application of the Concept of Exemption
Book SynopsisIntended for use by government officials, and those working for regulatory bodies and operating organizations, this publication will assist in the application of IAEA Safety Standards Series No. GSR Part 3 in relation to the concept of exemption of practices or sources within practices from regulatory control. It addresses the application of a graded approach to the concept of exemption through the use of generic exemption and specific exemption. It explains the concept of exclusion and its relationship to exemption and clearance. The recommendations provided in this publication are applicable to all facilities and activities that use, manufacture, process, trade or store radioactive sources or material containing either natural or artificial radionuclides. The Safety Guide primarily addresses exemption from regulatory control in planned exposure situations. Although, the concept of exemption is only applicable to planned exposure situations, guidance on the application of a screening approach for decision making in managing certain existing exposure situations is also provided.
£41.75
