Facilitators from WHO and Health Canada took participants through the epidemiology of meningitis, basic vaccinology, development of PsA-TT, the manufacturing process, and testing performed, as well as how to review dossiers and to prepare an evaluation report.
At the end of the workshops, participants were expected to return to their institutions, receive and review dossiers and samples submitted by the manufacturer, and make a decision on registration of the product within 30 days of receipt of the submission and the reports from WHO.
Medical review dossiers for new ophthalmic drug and high-risk device approvals released publicly by the US Food and Drug Administration FDAA).
All data were obtained from medical review dossiers released to the public by the FDA, representing the key evidence considered by regulators when assessing a new product.
However, the online review dossiers are required by rule to include the "summaries, conclusions, and results of all clinical experience or investigations (whether adverse or supportive)…that are relevant to an assessment of the risks and benefits" of the device or drug, 50 and our study end points have been used in previous assessments of regulatory review dossiers.
Items in this category include meeting grant proposal deadlines, preparing your tenure review dossier, and so on.
Interestingly, none of the 50 reimbursement dossiers reviewed included economic analyses conducted alongside prospective clinical trials; this was mainly due to the fact that Hungary is too small market for conducting adequately powered prospective trials for local reimbursement purposes.
As we grind towards the southwest, I mentally review his dossier.
The manufacturers' dossiers were reviewed regarding their respective claims.
Legend: *Not hospitalized in last month before death or patient dossier not reviewed.
