Initial Preparations
Early Investigation
Pre-Clincal Development
Clinical Support
Wild Card
100
Stocking necessary reagents, supplies and equipment
What is material procurement
100
Generation of SOPs and optimization of testing approach
What is Assay Development?
100
Preserving large stocks for growth of new material
What is cell banking?
100
Administering vaccine to human subjects
What are Clinical Trials?
100
Two vectors that transmit Zika virus
What are Aedes aegypti and Aedes albopictus?
200
A document created prior to bringing in new agents to the laboratory
What is a Risk Assesment
200
The optimal amount of material to be administered
What is the vaccine dose?
200
Ensuring evaluations are fit for purpose
What is Assay Qualification?
200
Evaluation of adverse effects in pregnant models
What are Development and Reproductive Toxicology (DART) Studies?
200
When and where Zika was discovered
What is Uganda 1947?
300
A means for studying immune responses and antigen activity in an active system
What is identification of animal model
300
Observing for general responses following immunization or specifically at the injection site
What is Safety & Reactogenicity Assesment?
300
Evaluating the vaccine for adverse effects?
What is Toxicology?
300
Model evaluation of clinical approaches to vaccine administration
What are dose ranging studies?
300
Illness linked to infection of adults with Zika
What is Guillain–Barré syndrome (GBS)?
400
A panel of individuals who review documents prior to bringing new agents into the laboratory
What is the Institutional Biosafety Committee
400
Vaccine Proof of Concept
What is Efficacy in Animal Model
400
Fully characterized GMP product used for manufacturing
What is Pre-Master Seed virus?
400
Pre-clinical investigation of vaccine responses in subjects
What is Assaying Clinical Material?
400
WHO declaration regarding the Zika outbreak
What is a Public Health Emergency of International Concern (PHEIC)?
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