The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012 is a webinar that covers topics such as:
- 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
The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012 brings together:
- 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