Virtual Program: Pharmaceutical Hot Topics:2015 Review of FDA Initiatives & the 21st Century Cures A

When:  Dec 9, 2015 from 12:00 to 13:00 (ET)

Since the Critical Path Initiative’s launch in March 2004, FDA has introduced a number of programs aimed at reducing the gap between scientific knowledge and the availability of innovative medical treatments. Currently, the 21st Century Cures Act, approved by the House of Representatives, is being reviewed by the Senate, and could expand governmental efforts further to deliver much-needed cures and therapies. Register for this webcast to review how expedited review programs and special designations, the benefit-risk assessment framework and the patient-focused drug development program could enhance your company’s regulatory development strategy, and how these FDA initiatives have fared to date. You will become familiar with potential benefits and options the Cures Act could bring for your company’s regulatory and development strategy.

This program will update participants and provide regulatory considerations on each topic, reviewing tangible real-life examples gathered from previously approved or rejected new medicines, whenever possible. Speakers will discuss highlights of drug development from FDA initiatives and the Cures Act, with a focus on new medicines’ development. They also will provide insights on how these initiatives can benefit building or executing a regulatory strategy.

Learning Levels: Basic and Intermediate

Learning Objectives:
Upon the webcast's conclusion, you will be able to:

  • explain how FDA drug development initiatives could shape companies’ regulatory and development planning
  • review the government initiatives’ strategic advantages and challenges
  • provide insights from successful approvals stemming from those FDA initiatives, which could be applied during development strategy and planning

Who Should Attend?

  • Regulatory professionals
  • Clinical professionals
  • R&D personnel

Speakers

TBA