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The New AMCP Dossier Format Version 5.0: Key Implications for Strategic Approach
The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions is the industry standard for communicating clinical and economic information to meet the evidentiary requirements/needs of healthcare decision-makers (HCDMs) in the United States. The latest…
European Parliament’s Revision of the General Pharmaceutical Legislation
The European Parliament has adopted a revision of the general pharmaceutical legislation, repealing and amending previous legislation with a set of compromise amendments. According to the European Commission, it has been called “the largest reform in…
Strategic Launch: Accelerating Innovative Therapies in the Chinese Market
Given the recent business and sociopolitical environments, having the right business model is critical to successfully entering the China pharmaceuticals market. In this webinar, we will share relevant examples regarding how other life science companies responded to…
Market Access and the Inflation Reduction Act
The Inflation Reduction Act of 2022 (IRA) institutes Medicare changes that include the ability to negotiate drug prices, limit price increases and cap out-of-pocket costs for beneficiaries. Understanding the far-reaching implications of these provisions is crucial…
The AI Revolution in HEOR: How ChatGPT-4o and Multi-AI Agents Are Shaping the Future
Discover the future of Health Economics and Outcomes Research (HEOR) in our article, ‘The AI Revolution in HEOR’. Learn how AI, particularly ChatGPT-4o, is transforming the field with its enhanced speed and capabilities. Explore the potential…
A Review of Worldwide Indirect Treatment Comparison (ITC) Guidelines and Best Practices
Posted by
Krista Tantakoun , Christopher Olsen , Fatemeh Mirzayeh Fashami , Imtiaz Samjoo , Chris Cameron, PhD on June 12, 20246/12/24
Considering the challenges of conducting head-to-head clinical trials, indirect treatment comparisons (ITCs) offer valuable insights into clinical effectiveness that reflect current and local practices. These insights can help regulators and reimbursement agencies make better-informed decisions, thereby…
Championing Women’s Health and Equity
At Radical Health Festival Helsinki, Sr Innovation Manager, Anastasiya Markvarde, moderated a women-led panel on Closing the Funding Gaps. In this piece, we’re sharing Anastasiya’s takeaways from the session, steering the conversation toward twocritical gaps: the…
FDA Guidance and Considerations for Scientific Exchange Communication Strategies
In light of draft guidance issued by the U.S. Food and Drug Administration (FDA) regarding the communication of scientific information of unapproved uses (SIUU) of approved medical medical products, EVERSANA continues to assess the potential risk…
Updated Guidance May Ease MDR Transition for SaMD Manufacturers
The regulation of medical devices in the EU has been chaotic since the implementation of Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR). This upheaval has been particularly challenging for manufacturers facing a backlog…
Navigating the Evolution of Precision Medicine: Data-Driven Strategies for Life Sciences Commercialization
The landscape of pharmaceutical commercialization has undergone a remarkable transformation over the past decade. Traditional blockbuster drugs, once the hallmark of the industry, have given way to other products such as targeted therapeutics designed for rare…