レギュラトリーライティング
高品質なメディカルライティングとレギュラトリーライティングは、医薬品開発計画の成功に必要不可欠な要素です。Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.
Author: webdev
Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19
COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now. Speakers: Demetrius Carter, SVP … Continued
サターラが新型コロナウイルスの治療薬開発を支援するCOVID-19 Pharmacologyオンライン・リソース・センターを創設
Funded by the Bill & Melinda Gates Foundation, the online Center helps accelerate therapeutics for COVID-19 by integrating clinical pharmacology, innovation and collaboration
FDA Approval of Oral Testosterone Replacement Enabled by Phoenix NLME & Trial Simulator
Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
Enhance Your Drug Development Capacity with Clinical Pharmacology Study Execution & Operational Support
This webinar will explain both common pitfalls that sponsors experience and how clinical pharmacology study execution and operational support can increase the efficiency of your Phase 1 studies and improve the quality of data collected.
COVID-19の治療薬開発を加速
This webinar will explain lessons learned from preparing for and responding to viral outbreaks such as H5N1 and pH1N1 influenza and discuss how insights from model-informed drug development approaches can spur access to medicines for patients.
Payer-Pharma Perspectives on Outcomes-based Contracting
The adoption of outcomes based agreements (OBA) is growing given the urge among payers to reduce their exposure to risks of uncertain clinical value and budgetary impact, and the demand for drug manufacturers to demonstrate real world value to justify new, high-priced therapies and guarantee access to existing products exposed to increasing rebate levels. Prior to discussing practical considerations for the OBA implementation in this white paper, we’ve included the voices and rationales of two seasoned OBA pioneers and let you be party to their personal reflections.
The Shifting Landscape for Outcomes-Based Contracting
As health systems are driven to accept increasing accountability, payers and providers are looking for the biopharmaceutical industry to share the risks around performance of their products. Outcomes-based agreements (OBA) can be seen as the next chapter of the pay-for-value trend wherein the reimbursement for the pharmaceutical product is tied to the measurable ‘real world’ value it provides in terms of predefined outcomes.
The Six Stages to a Successful Value-Based Risk-Sharing Agreement
Outcome based agreements (OBAs) are a type of value-based risk sharing agreement between payers and drug manufacturers. OBAs are a useful tool for managing uncertainty regarding a drug’s real world clinical benefit, the economic impact to a payer’s budget, and market penetration. Read this white paper to learn about a six-stage process that will put you on the right path for attaining a successful OBA!
Optimizing the Regulatory Strategy for an Anti-cancer Drug
Certara scientists performed helped a small biotech company create a clinical pharmacology package for their NDA submission for a novel oncology drug.
