The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations
Course "The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency
Expectations" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon
full completion. Instructor Profile:
Date & Time: Thursday, June 21, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Robert J. Russell
Price : $245.00
Robert J. Russell President, RJR Consulting, Inc.
(for one participant)
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
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.
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.
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Areas Covered in the Session: l l l l
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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 Effective Interactions with the Global Regulatory Healthcare Authorities Helpful Websites
Click here to register for this webinar 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
Your Necessity is our Priority
CRAs and CRCs QA / Compliance personnel
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Investigators Clinical Research Scientists QA / QC Auditors and Staff Consultants
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 commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Published on May 17, 2012
This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medici...