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Bethesda North Marriott Hotel and Conference Center

2017 年 10 月 25 日 7:00 上午 - 2017 年 10 月 26 日 3:30 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Combination Products Conference

Innovation and New Frontiers

返回 Agenda

Session 2: 21st Century Cures and PDUFA: Combination Products Implications

Session Chair(s)

Carla Cartwright, JD, LLM

Carla Cartwright, JD, LLM

Director, Federal Affairs

Johnson & Johnson, United States

Explore how the combination product provisions of 21st Century Cures are being implemented by FDA and industry, the intent and impact of PDUFA VI looking at what is currently in place at FDA and what remains to be done. We will look at how reforms that were already underway, such as the CP Policy Council overlay with the 21st Century Cures requirements and PDUFA VI commitments for FDA. Exploring this from the vantage points of FDA, industry, and those with insights on the legislative intent will help us consider what more needs to be done moving forward and possibly define “success.”

Learning Objective :
Discuss FDA’s latest implementation efforts for 21st Century Cures in the combination product space
Describe implementation challenges from industry and FDA perspectives

Speaker(s)

Kalah Auchincloss

21st Century Cures from Three Sides: Hill, Agency, and Industry Perspectives

Kalah Auchincloss

Greenleaf Health, Inc., United States

Senior Vice President, Regulatory Compliance

Cartier Esham, PhD, MSc

Speaker

Cartier Esham, PhD, MSc

Biotechnology Innovation Organization (BIO), United States

Chief Scientific Officer

Speaker

Grace Stuntz

Senate HELP Committee, Republican Staff, United States

FDA Policy Advisor

Remy Brim

Speaker

Remy Brim

FDA, United States