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Improving quality of life through impactful leadership

💡New Insights💡 The U.S. Inflation Reduction Act (IRA) and E.U.'s Joint Clinical Assessment (JCA) together constitute the most consequential legislative shift for the pharma industry in decades, requiring the industry to answer more challenging questions within shorter timeframes. Are companies underprepared? How might they adapt? In this new, joint article by Wickenstones Ltd and WittKieffer, the authors explore the challenges of the IRA and JCA and share insights for how pharma companies can expand their readiness in terms of: Culture, Competency and Capacity, Structure and Governance, and Market Access. The new legislation "pushes the pharmaceutical industry towards a more functionally integrated operating model. Fully integrated teams, which bring clinical development and regulatory affairs into closer alignment with market access from the beginning of asset development, lead to efficiencies and enhanced outcomes." In essence, the IRA and JCA bring "opportunities for the industry to evolve, adapt, and future-proof its operating model." #pharma #pharmaceuticalregulation #lifesciences #pharmaoperations

New WittKieffer Insights | Navigating the Joint Challenges of US and EU Pharmaceutical Markets

New WittKieffer Insights | Navigating the Joint Challenges of US and EU Pharmaceutical Markets

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