Global Regulatory Affairs provides participants with an overview of the laws, regulations and Guidances governing the development and registration of prescription pharmaceuticals outside of the United States. Regions specific to our client’s needs are covered.
Global Pharmacovigilance focuses on introductory concepts of global regulatory requirements in drug safety. Topics include MedDRA, basic epidemiological issues, signal detection and risk management. Adverse event management exercises are included.
Regulation of Marketing and Promotion of Prescription Drugs addresses current laws, regulations and Guidances governing the marketing and promotion of prescription drugs and biologic agents. Hands-on exercises are also included. Prescription Drug Labeling Regulations is also offered.
Regulatory Inspections: Preparation and Practice explains the necessary steps in preparing for a Regulatory Site Inspection. Key topics include current inspection issues, differences in inspections from global agencies, handling inspections and preparing for inspections. A mock Site Audit is followed by a debriefing of the inspection findings. Also available: Preparing for an Advisory Committee Meeting.
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“As a pharmacovigilance professional, I now have a greater consideration of risk management and mitigation strategies.”
“This information will give me a clear foundation in my audit and prompts me to ask additional questions.”