MedCity Influencers

FDA, Xavier University to sponsor Medical Device Conference May 3-6

MedCon 2011 (co-sponsored by the FDA and Xavier University) will once again bring the global Medical Device Community together to share best practices and engage in open dialog with Global Regulatory Authorities and Industry Experts regarding critical issues faced by the industry. Hosted at Xavier University, Cincinnati, OH, beginning Tuesday May 3, MedCon 2011 features a comprehensive agenda of critical topics and global issues that impact the medical device industry.

MedCon 2011 (co-sponsored by the FDA and Xavier University) will once again bring the global Medical Device Community together to share best practices and engage in open dialog with Global Regulatory Authorities and Industry Experts regarding critical issues faced by the industry. Hosted at Xavier University, Cincinnati, OH, beginning Tuesday May 3, MedCon 2011 features a comprehensive agenda of critical topics and global issues that impact the medical device industry, including the following featured speakers:

  • Bill Maisel.  Deputy Director for Science.  FDA, Center for Devices and Radiological Health.
  • Kim Trautman. Medical Device GMP and Quality System Expert.  FDA, Center for Devices and Radiological Health.
  • Thinh Nguyen.  Director of the Office of Combination Products.  FDA, Office of Compliance.
  • Hugh McClure.  National Expert, Bioresearch Monitoring.  FDA.
  • Dr. Kenneth Ouriel.  Founder, The Ouriel Group.

“Response to the first global Medical Device Conference (MedCon 2010) was overwhelmingly positive,” explained co-chair Dr. Marla Phillips (Xavier University/former Merck). “We are very pleased to offer this year’s participants such high caliber speakers from both the FDA and from prominent medical device organizations with global impact.”

MedCon 2011’s plenary sessions are designed to enhance participants’ awareness of industry-moving perspectives on critical topics.  Attendees are then engaged in dialog as they attend three separate tracks of interest for Quality Assurance, Regulatory Affairs and Clinical Trials. Additional breakout sessions include:

Clinical Track:

  • Ethical Issues Leading to Non-Compliance
  • Warning Letter Trends for Sponsor-Monitors and CROs
  • Ensuring Site Compliance
  • Using Electronic Medical Records
  • Cooperative Research Activities Between Academia and Industry
  • FDA’s Proposed Rules on How to Report Fraud in Clinical Trials
  • FDCA, Anti-Kickback and False Claims Act, Implications of Investigator-Initiated Trials
  • Adverse Event Reporting During Clinical Investigation in the EU
  • Clinical Evaluation for EU Market Access

Quality Track:

  • Risk Management — Quantitative Approach
  • Supplier Controls
  • Corrective and Preventive Actions
  • Inspection Readiness
  • Regulatory Requirements for Training and Recent Enforcement Actions
  • Recalls, Requirements and Challenges (GHTF Study Group 2 and current state)

Regulatory Track

  • 510(k) changes, current interpretation of guidance
  • 510(k) SE Decision Making Process
  • Class IIA and Class IIB discussion
  • Advertising, Promotion & Labeling Pre- and Post-Market
  • Combination Products
  • International Update
  • CE Mark

MedCon 2011 will benefit companies of all sizes and employees at all levels including professionals in Regulatory Affairs, Quality Assurance, Clinical Research Professionals, Risk Management Experts, Executive Management, Research and Development, Medical Device Manufacturers and Contractors and Consultants.

There are substantial discounts for early registration for MedCon 2011. To register today, visit Medcon online at www.XavierMedCon.com.

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