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Approaches to Combination Product Clinical Study Protocol Design and Execution

Our Price: $395.00

Product Code: WB-7008

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About the Product
Includes 50 minute Windows Media Video File and PowerPoint presentations for immediate download.

The surge in use of combination products has made clinical studies a top priority for manufacturers and companies looking to break into this area. Clinicians are often responsible for the difficult task of determining which requirements apply to combination products and how to apply these principles. Studies are also usually more costly, comprehensive and complicated than those of individual drugs, devices or biologics as multiple constituents are being evaluated not only by themselves, but as a group as well. Issues concerning clinical trials involving combination products are of great importance to patients, manufacturers as well as regulators.

  • Utilizing both constituent product and combination trial data
  • Determining the clinical investigation applications: IND or IDE?
  • Pre- clinical and post- market study development considerations
  • Clarification into adverse event reporting processes

Karen Fraser

Target Audience

  • Clinical Research & Operations
  • Scientific Affairs
  • Research & Development
  • Strategic Planning
  • Project Management

Target Industry:
  • Pharmaceutical Manufacturers
  • Medical Device Manufacturers
  • Diagnostic Manufacturers

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