Transcription of Simonetta Viviani, MD - DCVMN
{{id}} {{{paragraph}}}
Example: confidence
Simonetta Viviani, MD - DCVMN
Simonetta Viviani, MD. BIO-VIPE Consulting Limited, Hong Kong DCVMN Clinical Development & Pharmacovigilance Training 17-21 July 2016 , Bali, Indonesia vaccine Development is a Risky, Time Consuming and Expensive Process Research Phase Early Development Late Development Registratio Phase Phase n Phase Produce Phase I Phase II Phase III. Identify Test in Safety Dose E cacy File License Antigens Antigens Animals Immuno Safety Safety 2-3 years 2-3 years 2-3 years 1-3 years 7 12 years Stages in vaccine development Non clinical development Marketing &. Manufacturing Registration sales Discovery Research Clinical development Efficacy Effectivness Pharmacovigilance vaccine development vaccine development is an integrated process Preclinical development Research & Clinical Discovery Development Regulatory Manufacturing Development Clinical Development Plan (CDP). CDP describes the clinical strategy and methodology to generate a clinical database that will support marketing authorization application (MAAR).
Clarke E. et al. Safety and immunogenicity of inactivated poliovirus vaccine when given with measles-rubella combined vaccine and yellow fever vaccine and when given via different administration routes: a phase 4, randomised, non-inferiority trial in The Gambia. Lancet Global Health 2016 Jun 27.
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: