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Bethesda North Marriott Hotel and Conference Center

2025 年 02 月 03 日 7:45 上午 - 2025 年 02 月 05 日 12:45 下午

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Advanced Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 7, Track 2: Towards Instantaneous Approvals in 5 Years: What Would it Take to Get There?

Session Chair(s)

Cary  Smithson, MBA

Cary Smithson, MBA

Managing Partner

LeapAhead Solutions, Inc., United States

Human biology is almost hopelessly intricate, making it almost miraculous that we have efficacious treatments. In contrast, the framework we use to accept evidence of safety and efficacy needs not be this complex. We believe it offers a practical and surmountable challenge to speeding up patients’ access to life saving treatment by combining better technology, and ethical and more courageous risk management. The output of this hands-on workshop will be consolidated in a multi-stakeholder framework publication.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss current submission and approval process
  • Brainstorm opportunities to significantly shorten submissions and approval timelines
  • Formulate and execute a high-level plan with interim goals that will get us closer to an 'instantaneous approval' in the appropriate circumstances

Speaker(s)

Tony  Fantana, PhD

Author

Tony Fantana, PhD

Eli Lilly, United States

Sr. Dir

Peter Pedro Caetano, PharmD, PhD, MBA, MPH

Speaker

Peter Pedro Caetano, PharmD, PhD, MBA, MPH

Ipsen, United States

Global Regulatory Affairs – Senior Director

Tala  Fakhouri, PhD, MPH

Speaker

Tala Fakhouri, PhD, MPH

FDA, United States

Associate Director for Data Science and Artificial Intelligence, CDER

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