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

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. This translates to company and personal success and for new therapies to continue to be available to patient populations worldwide.

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.

Areas Covered in the Webinar :

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

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

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