Innovative Regulatory Pathways Summit – Innovative Regulatory Pathways Summit

There are regulatory mechanisms in place to accelerate the review and/ or approval of treatments for patients. In the United States, Accelerated Approval, Breakthrough Therapy Designations, Fast Track Designation, Priority Review, and the Orphan Drug Act are designed to expedite treatment availability for medications that provide an increased benefit over existing treatments.

Breakthrough therapy designations and other expedited pathways encourage sponsors to increase communication and collaboration with the FDA, to enable efficient drug development. Accelerated drug development options are also available globally in ICH countries through programs like PRIME and Sakigake. Understanding how to best utilize these regulatory options is imperative to make an informed decision about the best ways to accelerate drug development.

ExL’s Innovative Regulatory Pathways Summit will bring together leading regulatory experts and thought leaders to discuss breakthrough therapy designations, accelerated approvals, and global regulatory strategies to expedite review/approval of drugs that have promise in treating serious or life-threatening conditions.

Top Five Reasons to Attend

  1. Navigate the expedited drug development options provided by the FDA
  2. Discuss clinical requirements for breakthrough therapy designation and the impact of receiving designation on trail design/CMC plans
  3. Utilize patient-focused drug development to build clinical trial frameworks for breakthrough therapy applications
  4. Discuss regulatory strategies to expedite oncology and rare disease product development timelines
  5. Compare Sakigake, PRIME, and Breakthrough Therapy Designation to expedited tracks in non-ICH countries

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies and advocacy groups with responsibilities in the following areas:

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

This conference is also of interest to:

  • Regulatory Advisors/ Service Providers/ Consultants
  • Clinical/Contract Research Organizations
  • Drug Development Service Providers
  • Law Firms
  • Preclinical/ Analytical Research Organizations
  • Strategic/ Management Consultants
Startdate: 2018-01-29
End Date 2018-01-30

Description: ExL’s Innovative Regulatory Pathways Summit will provide attendees with a platform to discuss and compare the expedited regulatory pathways that allow for attention to drugs that have promise in treating serious or life threatening conditions
Performer: ExL Events
Address : Regulatory Affairs Conference