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.
Essentially Similar and Generic Products.
Cross-Agency Interactions: Comparing U.S. FDA and EMA.
Effective Interactions with the Global Regulatory Healthcare Authorities.
Helpful Websites.
Who Will Benefit:

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology and CRO industry conducting Clinical Trials including:

- Sponsor Senior management
- Project Managers
- Clinical Trial Heads
- Medical writers
- Project Managers
- CRAs and CRCs