june, 2015

03junallday04alldayFDA-OCRA Annual Educational Conference – The Current Regulatory Landscape: Opportunities and ChallengesIrvine, CA


Event Details

Join Halloran on June 3-4, 2015 at the FDA – Orange County Regulatory Affairs (OCRA) Annual Educational Conference – The Current Regulatory Landscape: Opportunities and Challenges. President & CEO, Laurie Halloran, and Senior Consultant, Omid Khodai, present a panel on “Challenges in Clinical Studies.”

The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and OCRA that affords attendees maximum interaction with both LA District and Washington-based FDA personnel.

Who Should Attend

Regulatory Affairs/Compliance • Clinical Affairs/Auditors • Legal Staff • Quality Affairs/Quality Control • Marketing & Advertising • Product Development • Consultants & Analysts • Operations & Management

Plenary Topics:

  • Beyond the 483: Criminal Prosecution
  • FDA Regulation of Mobile Medical Applications

Second Day Breakout Sessions:

  1. Clinical Trials: Real World Reasons Why Proper Pharmacovigilance Matters, Practical Approaches: How Stakeholders Can Better Advance Clinical Trials, US Clinical Trials Design, Challenges in Clinical Studies (Drugs and Devices)
  2. Dietary Supplements: New Product Development, Labeling, Advertising and Promotions, Clinical Studies and Design, FSMA (Food Safety Modernization Act) Impact on Dietary Supplement Companies
  3. International: International Quality System Management, Notified Body and Registrar Inspections, Understanding Clinical Equivalence: It’s Not Substantial Equivalence, Regulatory International Updates in Times of Crisis
  4. Medical Devices and IVD: After the FDA comes to visit: From a 483 to What We Do Today, Comparison of Early Stage Start-up Entities to Established Big Business, Strategic Planning for Product Registration: Tips and Tools for Class II and Class III Devices, U.S. Pre-market Submissions: Hot Topics and FDA Update
  5. Drugs and Biologics: Pricing and Reimbursement, Recalls and Market Withdrawal Processes, Strategic Planning for Product Registration, New Regulatory Updates

Date: June 3 – 4, 2015
Place: Irvine Marriott
18000 Von Karman Avenue
Irvine, CA 92612
Cost: $725 for members / $775 for non-members


june 3 (Wednesday) - 4 (Thursday)


Irvine Marriott

1800 Von Karman Avenue, Irvine, CA 92612