Training

We can prepare and teach tailored on- or offsite training courses or seminars at reasonable rates on the following topics:

  • Safety Evaluation for Pharmaceuticals, Medical Devices, Biologics, or Combination Products
  • Statistical Design and Analysis for Preclinical Toxicology
  • Functional Observational Battery Performance in Rodents and/or Dogs (in lab training)
  • Risk Assessment for Pharmaceuticals, Medical Devices, Biologics, or Combination Products
  • IDE/IND/510(k) Preparation
  • Safety Pharmacology
  • Successful First in Man Clinical Trials
  • GLP Report Writing
  • Pharmacovigilance
  • Impurity qualification, (Q)SAR and risk assessment

Our most recent trainings & presentations include:

  • “International Risk Assessment Seminar on Qualification of Impurities, Leachables, Extractables; Residual Solvents and Excipients”. Hosted by Association of Toxicology, Bengaluru, India. February 8-10, 2016.
  • “Qualification of Impurities: (Q)SAR and Other Tools”. Hosted by Dr. Reddy’s, Hyderabad, India, February 11, 2016.
  • “Drug Development and Nonclinical Safety Evaluation”. Hosted by RTI, RPT, North Carolina. February 16-17, 2016.
  • “Nonclinical Drug Safety Evaluation & Drug Development”. Hosted by CFPA, East Brunswick, New Jersey. November 2-4, 2015.
  • “(Q)SAR and Risk Assessment Workshop”. Hosted by Gad Consulting Services, Raleigh, North Carolina. April 20-22, 2015.