New York Professional Events List

Innovative Regulatory Pathways Summit (exl) AS

Jan 29, 2018 - 08:00 AM - Jan 30, 05:00 PM
New York Media Technologies LLC in association with EXL Events Inc
WashingtonWashington, DCUnited States,

ZIP: United States


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 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.

Top Five Reasons to Attend

  1. Navigate the regulatory landscape and effectively anticipate the future accelerated options
  2. Discuss the implications of breakthrough therapy designation and other approval tracks
  3. Network with worldwide leading regulatory experts, sponsors and healthcare providers
  4. Discuss regulatory strategies to optimize product development timelines
  5. 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


Please contact the event manager Marilyn below for the following: 
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase. 
We can also provide a certificate of completion for this event if required.

This Event Listing is Promoted by
New York Media Technologies LLC in association
with EXL Events Inc
MYL170811CEV MAR170926UPT


Event Categories
Keywords: fun, business , Clinical , communication , conference , design , development , Eating, Fun , Health


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