Search
Use the filters to narrow by type of content
Looking for a Publication? Search the bibliography for: publications fundamentals us regulatory affairs
HTA and Reimbursement Considerations for Orphan Drugs in European Markets HTA and Reimbursement Considerations for Rare Diseases in European Markets: What Are the Implications for Manufacturers? Heyes A, McBride D, Pearson I, Copley-Merriman C …
… that she has led include the use of databases to address regulatory agency-required pregnancy safety studies, …
… Contract Research Organizations, an independent IRB, the US Food and Drug Administration and a generic pharmaceutical … teams and studies. She has successfully hosted numerous regulatory inspections (US FDA & Japan PMDA) in several countries (US, Japan, UK, …
… in the field of pharmacoepidemiology. His experience and publications span many therapeutic areas, including kidney …
Real-World Evidence Fills Gaps in Blood Cancer Research Share on: February 12, 2022 Most of what we know about treatments, adverse events, and the overall survival of patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) comes …
… culture. As with many other cultures, our cuisine reminds us of family history and cherished times spent with loved … with whom we do not interact regularly can cause us to not consider their needs or to disregard those needs …
… symptoms), even when taking one of these medications. The US Food and Drug Administration has approved three on-demand …
… Therapeutic Experience Explore our Projects, Publications, and Researchers by Therapeutic Area To help …
Episheet Spreadsheets for the Analysis of Epidemiologic Data Episheet is a spreadsheet workbook that evolved from a collection of programs for first-generation programmable calculators ( Epidemiologic Analysis with a Programmable Calculator ), by Kenneth …
Services You must make critical decisions in today’s complex, competitive, and highly regulated pharmaceutical, medical device, and diagnostics industry. However, often, the knowledge needed to make good clinical, market access, and safety decisions isn’t …