FDAnews Announces — Inside FDA’s Oncology Center of Excellence: What Regulatory & Quality Professionals Need to Know Webinar, June 13, 2018

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The year-old FDA Oncology Center of Excellence (OCE) is tasked with expediting development of oncology and hematology medical products, drugs, biologics and devices and supporting an integrated approach to clinical evaluation of cancer treatments. Yet many drug/biologics and device makers, researchers and CROs still know too little about what OCE is and what it does.

Inside FDA’s Oncology Center of Excellence:
What Regulatory & Quality Professionals Need to Know
**An FDAnews Webinar**
June 13, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/insidefdasoncologycenter        

The FDA is a cop, sure, but it is many other things as well. Among these roles is to advance the science of medicine.

Take cancer therapies. The year-old FDA Oncology Center of Excellence (OCE) is tasked with expediting development of oncology and hematology medical products — drugs, biologics and devices — and supporting an integrated approach to clinical evaluation of cancer treatments.

Yet many drug/biologics and device makers, researchers and CROs … the very folks who stand to benefit most … still know too little about what OCE is and what it does.

FDAnews set out to rectify this situation, inviting OCE’s director and deputy director to share what they know with the folks who could benefit the most.

Over the course of a fast-paced hour and a half, director Richard Pazdur MD and deputy director Amy McKee MD will open a window on the OCE to reveal:

  • OCE structure: Where this Center of Excellence sits within the FDA and how it interacts with other agency Centers of Excellence
  • The regulatory role, encompassing nuances such as formation of clinical review teams for oncology products
  • Who does what: Roles of OCE staff, including outreach, immune-oncology, targeted therapy, cellular therapy and bioinformatics
  • OCE research, including real-world-evidence research and the NGS laboratory
  • OCE outreach, including interactions with professional societies and patient or advocacy groups
  • And much more!

Meet the Presenters:
Richard Pazdur M.D. is director of the FDA's Oncology Center of Excellence (OCE), tasked with expediting development of novel drugs, biologics and devices to treat cancer by leveraging the combined skills of the FDA's regulatory scientists and reviewers. Dr. Pazdur leads agency efforts to develop and execute an integrated regulatory approach that enhances the cross-center coordination of oncology product clinical review.

Amy McKee M.D. is Deputy Center Director, OCE, with a background in pediatric hematology/oncology and neuroblastoma research. At the FDA she reviews new molecular entities for marketing approval in oncology, including presenting these applications at the Oncologic Drugs Advisory Committee.

Who Will Benefit:

  • Regulatory affairs
  • Quality control/GMP
  • Medical directors
  • Strategic planners
  • Drug and oncology development specialists

Webinar Details:
Inside FDA’s Oncology Center of Excellence:
What Regulatory & Quality Professionals Need to Know
**An FDAnews Webinar**
June 13, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/insidefdasoncologycenter        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/insidefdasoncologycenter                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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