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… PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information Exchange (PIE) … Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved use dossier, allows you to … and devices available for patients as rapidly as possible. AMCP Approved Product Dossiers The AMCP format has been …
… perform the full package of research underpinning AMCP dossiers and preparation for ICER engagements to support …
… 6 Takeaways on the AMCP 4.1 Guidance in Action Share on: March 12, 2021 … which provides guidance for formulary submission dossier development. The updated guideline provides guidance … preliminary to be included in the early dossiers. Takeaway 5: Provide materials to develop the product information …
… FDA and AMCP Guidance on Pre-Approval Submissions and the Continuous Process of Dossier Development Share on: December 20, 2019 Article … Guidance Version 4.0 (April 2016) The AMCP Format v4.0 states that manufacturers may use the pre-approval …
… Webinar: Creating a Successful Global Value Dossier Share … Your Therapeutic Product's Value You need a global value dossier (GVD) that effectively presents evidence-based …
… Creating a Successful Global Value Dossier Webinar Q & A Thank you for attending our webinar! Below are … about how we can help you with your specific Global Value Dossier needs, please contact our team using the form to the …
Surveys and Observational Studies Beyond the evidence standards set by traditional clinical trials, well-designed and implemented surveys and observational studies can help you, your patients, regulators, and prescribers understand the real-world use, …
Global Value Dossiers and Other Value Communication Materials Your messages need to be flexible, tailored to each of your audiences, and clearly articulated. Let us help develop your global value dossiers (GVDs) and other high-impact communication tools …
… Webinar: HEOR Evidence for Emergent Infectious Diseases Share on: Thursday, September 16, 2021 View Now Generating and communicating evidence … from a continually changing environment. In this 1-hour webinar, we’ll look at the opportunities and challenges that …
… Webinar: Market Access Evidence Roadmaps Share on: Tuesday, June 16, 2020 Watch Recorded Webinar Maximizing Asset Value Through Evidence Generation …