16 Postmarketing Spontaneous ICSR/SAE Reporting Postmarketing spontaneous reporting of Individual Case Safety Reports (ICSRs) is the mainstay of drug safety at this time. General Principles The requirements for reporting…
41 How an Individual Case Safety Report (ICSR) Is Handled from Start to Finish This chapter traces an adverse event (AE) through its course in a company from start to…
46 Toxic Effects of Immunogenicity to Biopharmaceuticals Ana T. Menendez, PhD Introduction Biopharmaceuticals developed by recombinant DNA technology are delivering their great promise in therapeutics because of their excellent targeting…
35 Pregnancy and Lactation Testing pregnant animals is done as part of the usual preclinical development of new drugs, but a drug that is not teratogenic (leading to congenital malformations)…
29 The Roles and Interactions of Companies, Governments, Nongovernmental Organizations (NGOs), and Others in the World of Pharmacovigilance There are many players in the world of pharmacovigilance. The interactions are…
50 Ethical Issues and Conflicts of Interest NOTE: The comments in this chapter represent those of the author and not of the organizations of which he is or has been…
20 Information Technology, Databases, and Computers Any company that receives more than a handful of AEs, whether for marketed products or for products only in clinical trials, needs a database…
15 Expedited and Aggregate Reporting in Clinical Trials There are multiple different safety reports that pharmaceutical companies and other sponsors must submit to health authorities. This chapter reviews the key…
22 The European Medicines Agency (EMA, EMEA) In 1995, the European Medicines Evaluation Agency (EMEA) was created and based in the Canary Wharf section of London, England. Now, over a…
