Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
Why you should 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. This translates to company and personal success and for new therapies to continue to be available to patient populations worldwide.
Areas Covered In the Session:
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
Essentially Similar and Generic Products
Cross-Agency Interactions: Comparing U.S. FDA and EMA
Effective Interactions with the Global Regulatory Healthcare Authorities
Who will benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry conducting Clinical Trials including: