Fundamentals of International Regulatory Affairs, Second Edition

Since its launch in 1999, Fundamentals of US Regulatory Affairs has been RAPS' top selling publication-relied upon by those new to regulatory and trusted by seasoned professionals. The much anticipated international edition-Fundamentals of International Regulatory Affairs-is now available!Whether you are new to regulatory affairs, preparing for the RAC (General Scope) Exam or looking for a touch-up of the fundamentals in your field, the Fundamentals of International Regulatory Affairs, First Edition will serves as an excellent reference tool to put you on the right path in your career. This essential text provides a comprehensive understanding of established international regulatory requirements across product linesFeaturing: * International guidance documents from ICH, GHTF, WHO and ISO * Comparison of submission requirements around the world * Illustrative figures and tablesRegulatory students: Ask you professor about special RAPS pricing on the Fundamentals series.RAPS does not accept exchanges or returns on items that have already been shipped or emailed. Cancellations of orders must be made within 24 hours from the time the original order was placed.