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Dr. Darpesh Gohel, delivered a lecture on Non-Clinical Vaccine Safety Evaluation: Regulatory Perspective  at the CPHI Vaccine Summit 2015 on 24th November, 2015.

Dr. Darpesh Gohel, delivered a lecture on Non-Clinical Vaccine Safety Evaluation: Regulatory Perspective at the CPHI Vaccine Summit 2015 on 24th November, 2015.

  • 25-Nov-2015

Dr. Darpesh Gohel is leading the Chronic and Mammalian Toxicology Department and working with JRF for more than 7 years. He has done his M.V.Sc. in Veterinary Pharmacology from Anand Agricultural University, Anand, Gujarat (India).

 

Overview

  • Why Safety Evaluation of Vaccines??
  • Non-clinical Safety Testing Requirements
  • Vaccine Development – FDA Perspective
  • Vaccine Nonclinical Studies type and its study design
  • Nonclinical Safety: Other Toxicity Evaluation

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