The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012

  • 08 Nov 2012
  • Webinar

Description

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012 is a webinar that covers topics such as:

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

The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations 2012 brings together:

  • Project Managers
  • Sponsor Senior management
  • Medical writers
  • Clinical Trial Heads
  • CRAs and CRCs
  • Project Managers
  • Investigators
  • QA / Compliance personnel
  • QA / QC Auditors and Staff
  • Clinical Research Scientists
  • Consultants

Past Events

Important

Please, check "The Investigational Medicinal Product Dossier (IMPD): EU CTA vs. FDA IND: Comparing the Content and Agency Expectations" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical technology, Pharma

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