Innovative Regulatory Pathways Summit


The Innovative Regulatory Pathways Summit covers topics such as:

  • 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

The Innovative Regulatory Pathways Summit brings together 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


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

Future Events

Past Events


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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