The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations at fremont 2017

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.

Product Id : 501059
Instructor : Robert J. Russell

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.

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
• 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
• QA / Compliance personnel
• Investigators
• Clinical Research Scientists
• QA / QC Auditors and Staff
• Consultants

IMPORTANT DATE:

Webinar Date: Tuesday, January 24, 2017 | 10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes

Others Details

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