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Omni Shoreham Hotel

22 ene 2018 7:00 a.m. - 24 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Mid-Day Keynote

Session Chair(s)

Simone P. Pinheiro, MSc

Simone P. Pinheiro, MSc

Head, PharmacoEpidemiology Center of Excellence (PeCoE)

AbbVie, United States

The FDA is committed to facilitating rapid development, review and action on promising cancer treatments. This exciting DIAmond session will discuss recent progresses and novel approval pathways for oncology therapeutic products, including real world evidence. This session will also discuss the Oncology Center of Excellence, developed as part of the 21st Century CURES Act, and its role in the development of regulatory approaches to expedite drug development. This 45-min session will be composed of two presentations followed by Q&A.

Speaker(s)

Sean  Khozin, MD, MPH

Novel Approaches in Oncology Products

Sean Khozin, MD, MPH

CancerLinQ, LLC, United States

Executive Vice President of ASCO; Chief Executive Officer

Tamy  Kim, PharmD

Oncology Center of Excellence

Tamy Kim, PharmD

FDA, United States

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence

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