"CDRH will be sharing its internal HHE process at our conference. This information and insight is something that medical device industry executives have been seeking for a long time.” Thomas Maeder, Conference Director, Medical Device Summit
Washington Crossing, PA (PRWEB) April 27, 2015
For the first time, key representatives of the US Food and Drug Administration (FDA) will discuss, in detail, the internal process of the Center for Devices and Radiological Health (CDRH) for conducting a Health Hazard Evaluation (HHE).
Confirmed FDA speakers participating in the third annual Medical Device Summit conference on HHE, Risk Assessment & Recalls (May 12 - 13, 2015, Washington, DC) will include:
- Ron Brown – Chief, Recall Branch, DRMO, CDRH
- Kimber Richter, MD – Deputy Director for Medical Affairs, Office of Compliance, CDRH
- Kimberly Brown Smith, MD, PhD – Medical Officer, Office of Compliance, CDRH
- Lorie Erikson – Consumer Safety Officer, Office of Compliance, CDRH
“We are honored that CDRH will be sharing its internal HHE process at our conference. This information and insight is something that medical device industry executives have been seeking for a long time,” explains Thomas Maeder, conference director for Medical Device Summit.
“Moreover, we are especially delighted that these FDA officials, in particular, will be returning to our HHE, Risk Assessment & Recalls conference. In addition to providing essential information, their interactive style with attendees throughout all aspects of the conference provides an opportunity for key decision-makers to participate in open, frank discussions, which are invaluable,” adds Maeder.
Joining the FDA at this two-day conference in Washington, DC, will be speakers from leading companies including: Johnson & Johnson, Edwards Lifesciences, Phillips Healthcare, TerumoBCT, King & Spalding and Arnold & Porter. In addition to the FDA’s HHE process, specific topics will include:
- 2015 CDRH recall updates
- Status of guidances on product enhancements, eSubmitter and UDI and their relationship to recalls
- Transparency and alignment of FDA and industry HHE procedures
- When to launch an HHE
- Data sources for HHEs
- Feeding HHE and recall results back into other regulatory and quality functions
- Communicating with FDA during HHEs and recalls
- Risk assessment and recall decisions
- Internal deliberations and procedures leading up to recalls
- Recall communications to health care providers, distributors, patients, investors, the press, and other stakeholders
For more conference details, visit: http://bit.ly/HHEconfMay1213
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