Live Webinar
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The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectation
Date & Time: Tuesday, January 17, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Robert J. Russell
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
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.
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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
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Effective Interactions with the Global Regulatory Healthcare Authorities
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Helpful Websites
Robert J. Russell President, RJR Consulting, Inc. For the past 9 years, Bob 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. ...more
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Who Will Benefit: l l
Sponsor Senior management Project Managers
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Clinical Trial Heads Medical writers
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Project Managers
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CRAs and CRCs QA / Compliance personnel
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Investigators Clinical Research Scientists QA / QC Auditors and Staff
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Consultants
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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our