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… dossiers, preapproval information exchange (PIE), and real-world evidence (RWE). In this 45-minute webinar, our … AMCP Format V5.0 dossiers Hear about literature reviews, real-world evidence, and modeling strategies to support new …
… have been used to answer problems such as sparse data, time-to-event data, treatment interaction effects, and how real-world evidence (RWE) can be incorporated into an NMA. How …
… by the US Food and Drug Administration to benefit eventual market access. Since the new guidance release, RTI Health … may view it as an opportunity to present as much clinical data as early as possible. These objectives may also differ … the appropriate timing for developing a UPD vs. a post-approval AMCP dossier, understand that the two are not …
… Adverse Cardiac Events in COPD Patients Treated with Inhaled Bronchodilators … infarction, stroke, and other major adverse cardiac events in new users of aclidinium, aclidinium/formoterol, and …
… to address this challenge by integrating expertise and data from multiple European Research Centres. The new … MISSION is to provide trusted pharmacoepidemiologic and real-world evidence (PE/RWE) research through a European federated …
… Poster Sessions at ICPE, and serving on the Scientific Program Committee, Public Policy Committee, and RWE Task …
… 10:30am - 12:00pm EST Considerations for planning safety surveillance studies of COVID-19 vaccines Alicia Gilsenan, …
… for Sanofi Pasteur for the Global Influenza Hospital Surveillance Network project. During these two years, she … projects as a Senior Clinical Project Coordinator in the Real World Late Phase Department at Quintiles. She has more than 5 …
… to help ensure they had robust evidence to support optimal market access. OUR APPROACH For each indication, we performed … evidence needed to generate dossiers, economic models, and real-world evidence to support the product launch. developed an …
Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the FDA’s Clinical Outcome Assessments (COA) team and a wide variety of reviewing divisions on numerous occasions to select and …