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RAPS pre-approved webinar on The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA I

Events & Concerts

(Free Press Release) “The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND” is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on June 4. Robert J. Russell, President of RJR Consulting, Inc. will be the Speaker at this 90-minute webinar, which earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

RAPS pre-approved webinar on The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA I


      

 

Description:

This webinar gives a comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between an EU CTA Application and an FDA IND Application.

Having the knowledge and efficiency in completing successful applications for their studies is of utmost importance to sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development. This is because knowing what is expected and getting it right the first time will allow faster development of innovative products. The result of all this is personal and company success, which in turn paves the way for the availability of new therapies to patient populations worldwide.

This webinar will also cover 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.

o US FDA and EU Agency Orientation/Structure

o Start-up and conducting clinical trial processes

o Following Product Registration/Licensing Options

o Company Strategy –Linking Clinical Trials & Marketing Authorization Applications

o Balancing strategy and long term regulatory cost & maintenance

o IMP dossier & comparisons of the US IND to the EU CTA content

o Scientific Advice: Member States vs. Pre-IND meetings with U.S. FDA

o Orphan drugs: EU vs. US treatment

o GCP Compliance Inspections

o Essentially similar and generic products

o Cross-agency interactions: comparing U.S. FDA and EMA

o Effective interactions with the global regulatory healthcare authorities

o Helpful websites

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When:June 4, 10:00 AM PDT | 01:00 PM EDT

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By whom:Robert J. Russell is 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, and 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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For whom:

The webinar will benefit

o Sponsor Senior management

o Project Managers

o Clinical Trial Heads

o Medical writers

o Project Managers

o CRAs and CRCs

o QA/Compliance personnel

o Investigators

o Clinical Research Scientists

o QA/QC Auditors and Staff

o Consultants

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Duration: 90 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Phone: 800-447-9407

 




RAPS pre-approved webinar on The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA I

Source: Press Release

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