The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Jun 21, 2016
Length
90 minutes
Product Description

Get a Comprehensive Understanding of the IMPD

 

This 90 minute training course will provide you with 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 with expert speaker Robert Russell 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.

Training Highlights:

  • 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

Benefits

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.

Who Should Attend

The ideas and strategies discussed in this webinar will be relevant to:

  • Sponsor Senior Management
  • Project Managers
  • Clinical Trial Heads
  • Medical Writers
  • Project Managers
  • CRAs and CRCs
  • QA/Compliance Personnel
  • Investigators
  • Clinical Research Scientists
  • QA/QC Auditors and Staff
  • Consultants

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.


Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
More Events By The Speaker

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