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…

36 CIOMS This chapter summarizes the functions of the Council for International Organizations of Medical Sciences (CIOMS) and the reports issued by working groups created by CIOMS. These reports have…

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…