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SILEx MARCH 2023: Managing Difficult Drugs and Sponsors: Case Studies

Christine Copeman, BSc, Dip. Ecotox

Lauren Black, Ph.D.

  • This course covers four (4) real cases where adverse study outcomes or taxing sponsor interactions required problem solving and resolution.  These will highlight the importance of understanding the basics: product qualities, pharmacology and clinical applications, which, when thoroughly understood, allow us to design minimized, but translationally strong nonclinical research.  Working with the sponsors to understand the pressures they are under, and patients they are trying to help, forms a bond that proves to them that we care as much about their drug as they do!
  • How the basic science behind a drug, and how it is used in patients influences program design as well as regulatory strategy.  A failure to obtain and embrace these essential facts can lead to lost time, money, animals, and sponsor relationships. 
  • How the basic science behind a drug, and how it is used in patients influences program design as well as regulatory strategy.  A failure to obtain and embrace these essential facts can lead to lost time, money, animals, and sponsor relationships. 
Intended audience Veterinary staff members and Study Directors.

  • 1.00
Self enrollment (Learner)
Self enrollment (Learner)