The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012

Key Topics

• Start –Up and Conducting Clinical Trial Processes
• US FDA and EU Agency Orientation / Structure
• Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
• Following Product Registration / Licensing Options
• IMP Dossier & Comparisons of the US IND to the EU CTA Content
• Balancing Strategy and Long Term Regulatory Cost & Maintenance
• Orphan Drugs: EU vs. US Treatment
• Scientific Advice: Member States vs. Pre-IND Meetings with U.S. FDA
• Essentially Similar and Generic Products
• GCP Compliance Inspections
• Effective Interactions with the Global Regulatory Healthcare Authorities
• Cross-Agency Interactions: Comparing U.S. FDA and EMA
• Helpful Websites

Who should Attend

• Project Managers
• Sponsor Senior management
• Medical writers
• Clinical Trial Heads
• CRAs and CRCs
• Project Managers
• Investigators
• QA / Compliance personnel
• QA / QC Auditors and Staff
• Clinical Research Scientists
• Consultants