3rd Innovative Regulatory Pathways Summit 2020

Topics

• The implications of breakthrough therapy designation, PRIME, and Sakigake Designation on development pipelines
• The global regulatory landscape and effectively anticipate the future accelerated options
• Regulatory strategies to optimize product development timelines
• Leveraging the increased consideration that comes with utilizing an expedited development pathway
• Best practices to liaise with the FDA, EMA, and PDMA about expedited regulatory approvals

Who should Attend

Representatives from pharmaceutical, biotechnology, and medical device companies with responsibilities in:

• Business Development/Strategy
• Regulatory Affairs/Strategy/Operations
• Product Development
• Clinical Operations/Development/Affairs
• Patient Advocacy
• R&D/Drug Development
• Strategic Planning
• HEOR and Outcomes Research
• Oncology Program Management
• Competitive Intelligence
• Pipeline/Portfolio Management
• Rare Disease/Orphan Program Management
• Medical Information/Affairs
• Pharmacovigilance

Also:

• Clinical/Contract Research Organizations
• Regulatory Advisors/Service Providers/Consultants
• Law Firms
• Drug Development Service Providers
• Strategic/Management Consultants
• Preclinical/Analytical Research Organizations