2nd Innovative Regulatory Pathways Summit – 2nd Innovative Regulatory Pathways Summit

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

What does this really mean for sponsors and patients? Patients could have improved or novel treatments available sooner. While sponsors have successful tracks to obtain increased communication and collaboration with the FDA, enabling precise decision-making.

These regulatory options are available to ensure that FDA resources are allocated to review and approve therapies as soon as the benefits justify any risks. ExL’s 2nd Innovative Regulatory Pathways will serve as a platform to discuss and compare the current regulatory pathways that allow for earlier attention to drugs that have promise in treating serious or life-threatening conditions.

Learning Objectives

  • Navigate the regulatory landscape and effectively anticipate the future accelerated options
  • Discuss the implications of breakthrough therapy designation and other approval tracks
  • Network with worldwide leading regulatory experts, sponsors and healthcare providers
  • Discuss regulatory strategies to optimize product development timelines
  • Learn about best practices to liaise with the FDA on expedited regulatory approvals

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: 2019-01-28
End Date 2019-01-29

Description: ExL’s 2nd 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 : 2nd Innovative Regulatory Pathways Summit