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… we provide extensive research experience, industry and regulatory knowledge, and evidence-based tools to help …
… regenerative medicine development is changing. Expedited regulatory approvals can help developers, but only if they … planning and fully versed in the latest or upcoming regulatory requirements. Being ready to move forward … product has received fast-track designation, like the US FDA’s Regenerative Medicine Advanced Therapies (RMAT) or …
… February 7, 2024 Meeting website In response to a US Congressional request, an ad hoc committee of the National … of task. These include, but are not limited to: The use of regulatory flexibilities and supplementary data (e.g., …
… expect to see for your product to gain reimbursement. Let us help you answer critical questions about: Payer … committee, the Chief Medical Officer of a major private US insurer, and the Pharmacy Director for a large national … boards to address negative coverage policies in the US and disease area concerns worldwide. To get a well-rounded …
… an increasingly critical role to support successful regulatory approval and post-authorization commitments, … via new analytics. Beyond that, we can create reports for regulatory and HTA purposes as well as publications, interactive tools, and models to help you …
… include the implementation and management of ethics and regulatory submissions, patient and physician recruitment, …
… results (e.g., scientific conferences, peer-reviewed publications ) …
… GA Jennifer Luebke, JD, is Vice President for Legal & Regulatory Affairs at RTI-HS. Ms. Luebke oversees the negotiation and … and third-party suppliers. She is also responsible for regulatory compliance at RTI HS, leading a team that provides …
… 10 years in the pharmaceutical industry in drug safety and regulatory affairs. He has worked in a variety of therapy areas, … programs. While at Pfizer, Mr. Wolin acted as a global regulatory lead and was responsible for coordinating and …
… products or new uses of existing products before gaining regulatory approval by the US Food and Drug Administration to benefit eventual market … the inclusion of clinical data affect planned or pending publications? Manufacturers should determine the appropriate …