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

Featured Speakers

Conducting regulatory reviews of novel therapies in a timely manner is essential to improve public health concerns and ensure medical needs are met. There are regulatory mechanisms in place worldwide to accelerate the delivery of treatments for patients with serious diseases or unmet medical needs.

Many regulatory authorities throughout the world have implemented pathways that aim to expedite the submission or the review of products that cater to these medical needs. Understanding how to utilize expedited regulatory paths like Breakthrough Therapy Designation, PRIME, and Sakigake Designation is imperative to make an informed decision about the best ways to accelerate drug development.

These regulatory options are available to ensure regulatory bodies allocated the resources 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

  1. Navigate the global regulatory landscape and effectively anticipate the future accelerated options
  2. Discuss the implications of breakthrough therapy designation, PRIME, and Sakigake Designation on development pipelines
  3. Network with worldwide leading regulatory experts who have experience leveraging the increased consideration that comes with utilizing an expedited development pathway
  4. Discuss regulatory strategies to optimize product development timelines
  5. Learn about best practices to liaise with the FDA, EMA, and PDMA about 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