13 results on '"Bujar, Magda"'
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2. Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities
3. Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening
4. Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
5. An Evaluation of the Swissmedic Regulatory Framework for New Active Substances
6. A decade comparison of regulatory decision patterns for oncology products to all other non‐oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.
7. Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
8. Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice
9. How can regulatory policy functions in pharmaceutical companies measure their value and impact?
10. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016
11. FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines
12. How can regulatory policy functions in pharmaceutical companies measure their value and impact?
13. A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.
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