The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND

This 90 minute webinar will help you comprehensively understand the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application.

Why Should You Attend:

All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be efficient in completing successful applications for their studies. Knowing what is expected of you and “getting-it-right” the first time, will allow faster development of innovative products.

Areas Covered in the Seminar :

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