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

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					GlobalCompliancePanel                                                Your Gateway to Regulatory Compliance

Live Webinar on

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

Date: Tuesday, August 20, 2013                                       Time: 10:00 AM PDT | 01:00 PM EDT

   Duration:    90 Minutes
   Location:    Online                                                          Register Now
 Instructor:    Robert J. Russell

Course "The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND" has
been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC
recertification upon full completion.

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.


Areas covered in the session:

    l   US FDA and EU Agency Orientation / Structure
    l   Start -Up and Conducting Clinical Trial Processes
    l   Following Product Registration / Licensing Options
    l   Company Strategy- Linking Clinical Trials & Marketing Authorization Applications
    l   Balancing Strategy and Long Term Regulatory Cost & Maintenance
    l   IMP Dossier & Comparisons of the US IND to the EU CTA Content
    l   Scientific Advice: Member States vs. Pre-IND Meetings with U.S. FDA
    l   Orphan Drugs: EU vs. US Treatment
    l   GCP Compliance Inspections
    l   Essentially Similar and Generic Products
    l   Cross-Agency Interactions: Comparing U.S. FDA and EMA
    l   Effective Interactions with the Global Regulatory Healthcare Authorities
    l   Helpful Websites



Who Will Benefit:                                    About Speaker

                                                     Robert J. Russell
    l   Sponsor Senior management
                                                     President, RJR Consulting, Inc.
    l   Project Managers                             Robert J. Russell For the past 9 years, Bob has been
    l   Clinical Trial Heads                         President of RJR Consulting, Inc. The company assists
                                                     the pharmaceutical, medical device and biotech
    l   Medical writers
                                                     industries in understanding and complying with
    l   Project Managers                             International Regulations affecting compliance, new
    l   CRAs and CRCs                                product development, manufacturing and quality
    l   QA / Compliance personnel                    assurance. RJR has offices in Columbus, OH,
                                                     Washington, DC, Brussels, Belgium with exclusive
    l   Investigators                                affiliates across Asia and Latin America. Bob has 28
    l   Clinical Research Scientists                 years of past industry experience as a CMC specialist,
    l   QA / QC Auditors and Staff                   R&D Director and Global Director of Regulatory Affairs
    l   Consultants                                  for Merion   ...more



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DOCUMENT INFO
Description: 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.