• Drug Regulations
• Role of Regulatory Affairs in Drug Development / Approval / Marketing
• Registration Dossier
• Regulatory Strategy
• Variations: The Role of Regulatory Affairs after Marketing Authorization
• Transparency in Drug Regulatory Affairs

This course provides the knowledge and tools for experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:

• Regulatory Affairs
• Clinical drug development
• Preclinical drug development
• Pharmaceutical development
• Manufacturing
• Drug quality control
• Quality assurance and compliance
• Regulatory writing
• Drug import /export

At the conclusion of this course, participants should be able to:

• Define the drug legislation and regulation with a focus on the EU
• Demonstrate successful knowledge of the Internet to locate relevant documents
• Identify the key functions of regulatory affairs during the different phases of a drug life cycle
• Formulate successful regulatory strategies and apply it to the product concerned