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  6. FDA Public Workshop: Partners in Progress 2018 - Cancer Patient Advocates and FDA - 11/27/2018 - 11/27/2018
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Workshop

Event Title
FDA Public Workshop: Partners in Progress 2018 - Cancer Patient Advocates and FDA
November 27, 2018

Date:
November 27, 2018
Time:
08:30 AM - 04:30 PM EST
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Organized By:

The FDA Oncology Center of Excellence will hold its second annual educational workshop for new cancer patient advocates, Partners in Progress: Cancer Patient Advocates and FDA. The objectives are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development is most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy.

FDA Campus Information, (e.g., local airports, directions, and local hotels)

The FDA does not provide travel scholarships to attendees of this meeting.

In-person attendees will receive complementary food and beverages provided by the Supporting Organizations:

  • Cancer Support Community
  • Leukemia and Lymphoma Society
  • Susan G. Komen

Webcast Information:

FDA archived webcast of this meeting is available as follows: 

Webcast/Adobe Connect:

Meeting Information:

Speakers Presentations:

Welcome

Session 1: Introduction to the Role of FDA

Session 2: How Patient Engages Engage 

Session 3: Oncology Center of Excellence’s (OCE) Outreach Efforts 

Session 4: Insights into Cancer Drug Development 

Session 5: A Patient-Centered Approach to Efficacy Outcomes 

Session 6: Updates from FDA Centers on Recent Cancer Product Approval

Contact:

Virginia (Gini) Kwitkowski, MS, ACNP-BC
Center for Drug Evaluation and Research
Office of New Drugs
Office of Hematology and Oncology Products
Virginia.Kwitkowski@fda.hhs.gov


Event Materials

Title File Type/Size Source Organization
Speakers and Panelists Bios, Partners in Progress: Cancer Patients Advocates and FDA Workshop 11-27-18 pdf (162.3 KB)
Presentation: Welcome, Elizabeth Franklin PiP 11-27-18 pdf (1017.65 KB) FDA
Presentation: Welcome, Liza Holder, PiP 11-27-18 pdf (2.35 MB) FDA
Presentation: Welcome, Patty Spears PiP 11-27-18 pdf (436.48 KB) FDA
Presentation: FDA Myth Busters, Kwitkowski, PiP 11-27-18 pdf (439.11 KB) FDA
Presentation: Primer on Drug Development, Rosanna Setse, PiP workshop, 11-27-18 pdf (968.78 KB) FDA
Presentation: How FDA Involves Patient Advocates PiP 11-27-18 pdf (1.81 MB) FDA
Presentation: FDA's Patient Representative Program PiP 11-27-18 pdf (1.27 MB) FDA
Presentation: How Patient Advocates Participate in Drug Development, PiP 11-27-18 pdf (624.15 KB) FDA
Presentation: OCE Patient-Focused Drug Development Update, Kluetz, PiP 11-27-18 pdf (488.92 KB) FDA
Presentation: Pitfalls in Drug Development, Richardson PiP 11-27-18 pdf (533.8 KB) FDA
Presentation: Expanded Access Programs for Drugs and Biologics, PiP 11-27-18 pdf (616.5 KB) FDA
Presentation: Patient-Centered Approach: What Do Efficacy Endpoints Mean? Gao and Smith, PiP 11-27-18 pdf (188.23 KB) FDA
Presentation: Overview of 2018 CDER Drug Approvals in Hematology/Oncology, Ershler, PiP 11-27-18 pdf (349.3 KB) FDA
Presentation: Overview of Recent CBER Cancer Product Approvals, Bouchkouj PiP 11-27-18 pdf (559.97 KB) FDA
Presentation: Update from the Center for Devices and Radiologic Health, Ryan, PiP 11-27-18 pdf (1002.84 KB) FDA