Discover an informative webinar that explores the European Union (EU) joint clinical assessment and its profound impact on the health technology landscape.
The EU’s joint clinical assessment presents a paradigm shift in the assessment of new health technologies. While offering potential benefits such as streamlined evaluations and faster market access, it also brings forth a complex landscape of financial, regulatory and operational considerations for pharmaceutical companies.
This webinar will provide a comprehensive overview of the joint clinical assessment process, delving into its potential benefits, risks and challenges from multiple perspectives:
Financial: Examine the financial implications of joint clinical assessment, including potential cost savings through reduced duplication of efforts and the need for early investments in data generation and dossier preparation
Research & Development (R&D): Explore how joint clinical assessment influences R&D strategies, requiring early engagement with health technology assessment (HTA) bodies and potentially impacting clinical trial designs to meet specific data requirements
Market Access: Discuss the potential for accelerated market access across multiple EU member states through a single assessment and the continued importance of navigating individual national reimbursement decisions
Regulatory: Analyze the evolving regulatory landscape with joint clinical assessment, including the need for alignment with both European Medicines Agency (EMA) requirements and the specific expectations of the joint clinical assessment process
Operational/Resource: Address the operational complexities of joint clinical assessment, including resource allocation, coordination with multiple stakeholders and the need for robust data management and communication strategies
Register for this webinar today to gain insights into the financial, regulatory and operational challenges and opportunities that joint clinical assessment presents for pharmaceutical companies.
Keywords: Clinical Research, Market Access, Clinical Data, Regulatory, Regulatory Affairs, Regulatory Compliance, Pharmaceutical Regulation, RWE, Commercialization/HEOR/Market Access, RWD