Biography
A microbiologist by training with over 25 years experience in the veterinary medicinal products space. Trained in veterinary vaccine development several years before moving into regulatory affairs, primarily for veterinary vaccines but also veterinary pharmaceuticals. Experience with registration procedures for Europe, USA, Chile and Canada. Expertise in products for fish (cold and warm water species). Research interests
Late stage development, clinical trials, commercialisation of vaccines, registration, SME, limited markets Discipline
Bacteriology Bio-manufacturing Challenge study design Clinical trials – efficacy Clinical trials – safety Economics Registration Regulation Safety evaluation Virology Host species
Fish Pathogen
Bacteria Parasites Viruses Stage of vaccine development
Clinical trials Commercialisation Deployment Field trials Pre-clinical trials