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)…

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…

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…

44 Training Two broad and related areas are addressed here: (1) training of the drug safety staff and (2) training of the other employees in the organization who need to…

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…

18 Epidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages? This chapter is not meant to be an introduction to epidemiology or pharmacoepidemiology. There are many excellent…

13 Seriousness, Expectedness, and Causality The drug safety staff involved in individual case evaluation generally have to make several decisions regarding each case. These decisions must be made rapidly on…