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…
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…
37 International Conference on Harmonization (ICH) This chapter summarizes the purpose of the International Conference on Harmonization (ICH) and the reports issued by the various working groups related to drug…
