global compliance
510k Submission
by: martinlurthur, 2 pagesA premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug ...
How to Survive a DEA Inspection Series: DEA Due Diligence for Manufacturers and Distributors
by: martinlurthur, 2 pagesThe training will cover several recommendations to improve the Corporate Due Diligence when narcotic drugs are purchased by their customers and the steps that can be taken to detect and prevent the ...
How to Survive a DEA Inspection Series - For Manufacturers and Distributors
by: martinlurthur, 2 pagesThe training will cover DEA record-keeping and security requirements that DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced ...
Pharmacovigilance (Phase IV Trials) will be increasingly seen: What do they tell us and Why are they Important
by: martinlurthur, 2 pagesFDA-mandated post-market studies are here. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA ...
The Role of Lab Data in the Drug Development Process: Adverse Events Subject Safety
by: martinlurthur, 2 pagesAll Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure ...
