Event Info

Event: 2025 OCRA-DG Annual Conference
Time: 8am–8pm
Location: Irvine, CA
Date: Friday, June 6, 2025

Join regulatory agencies, industry leaders, and professional peers for a transformative event designed to inspire, educate, and connect.

Get your tickets today!

Registration will officially close on June 4, 2025

Reserve your spot in our biggest conference of the year! 

Sign up for 4 people and get 50% off for the 5th participant!

Sign up for 9 people and the 10th participant attends for free!

Attention Students: For discounted tickets, please contact amchair@ocra-dg.org from your school email address.

Interested in FREE Career Guidance?

Get a 15-minute exclusive session with Executive Recruiters in the pharmaceutical and medical device industry, including a free 1-1 Mock Interview! (Only available to Conference Attendees)

Click here for more information and to book your slot.

About the Conference

The conference features renowned speakers from the US FDA and EU Notified Body, as well as industry leaders and subject matter experts, many of whom are from the FDA.

Our full day Annual Conference provides industry professionals a cost-effective way to receive education and training from respected regulators and professionals, hear the latest on regulatory trends and changes, and obtain continuing education credits to maintain certifications.

Where permission is granted by the speaker, we will provide registered attendees with access to the presentation slides and recordings.

In-person attendees can book a hotel room here at 12% discount (click here).

About Sponsorship & Exhibits

For those interested in sponsoring OCRA-DG and/or exhibiting at the Annual Conference, we have sponsorship and exhibitor packages for all budgets. Please download the sponsorship and exhibit information and reach out to partners@ocra-dg.org. We will be glad to answer any questions you may have and help you pick the best package that suits your budget and objectives. Thank you for your support!

Facts About OCRA

Orange County Regulatory Affairs (OCRA) Discussion Group is a non-profit volunteer organization composed of Life Science Regulatory Affairs, Clinical, Quality Assurance, and industry professionals. OCRA offers courses for members interested in expanding their knowledge through educational programs and networking events. OCRA was formed in 1997 and quickly became one of the most vibrant and active non-for-profit, 501 (c) 3 volunteer-led professional organizations in the United States.

Who Should Attend

All professionals associated with health and life science fields.

Our focus is Regulatory in nature; however, the presentations will also provide valuable information for individuals involved in:

      • Product Development (software, artificial intelligence/machine learning, gene therapy, electrical safety, in silico technology)
      • Clinical (real world evidence, BIMO, post-marketing surveillance, in silico technology)
      • Marketing (advertising and promotional labeling)
      • Quality (GMP, quality management, electrical safety, artificial intelligence, biocompatibility, data integrity, etc.)
      • Owners, Executives, Entrepreneurs and other related fields.

Speakers

Opening Session
Year in Review
June-Mei Han
California FDB
Albert Rodriguez
California FDB
Device Industry Speaker
AI Impact on MDR Conformity Assessment
Balazs Bozsik
Technical Director – Medical Audit/SGS North America
Pharmaceutical Industry Speaker
Pre-IND Communication
Dr. Bruce W. Kovacs, MD
CEO of AfectaPharm
Device Panel Speakers
Which Way FDA, what should we expect in 2025?
Alan Stevens
Director, Regulatory Affairs, Combo Product, AbbVie
Carlos Torres
Senior Manager, RA US Advertising and Promotion, AbbVie

Felipe Martins

Associate Director, RA Global Regulatory Strategy, AbbVie
Pharmaceutical Panel Speakers
Pharmaceutical Labeling
Natalie Tolli
VP, RA Intercontinental/ Regulation and Policy Intelligence, AbbVie
Mirabelle Pao
Director, RA CMC, AbbVie

Emily Wawro

Director, RA Global Regulatory Strategy, AbbVie

Mock Interviews

  • Practice real interview questions with experience professionals
  • Get constructive, one-on-one feedback on your communication style and responses
  • Ask career-related questions and receive personalized advice from leaders in the regulatory and quality fields
  • Gain insight on how to stand out in the job market, whether you’re a student, early-career professional, or making a transition

Complimentary Professional Headshots

  • Enhance your professional profile
  • Take advantage of our Free Professional Headshot service available to all conference attendees. A professional photographer will be on-site to help you:
    • Update your LinkedIn and professional profiles
    • Present a polished image for job applications and networking
    • Receive high-quality digital photos and no-cost

Student Poster Presentations

We’re exited to feature a Student Poster Presentation & Contest at this year’s conference. This is a fantastic opportunity for students to:

  • Present their research to industry professionals and peers
  • Compete for awards and recognition
  • Network with potential employers and collaborators

Exhibit Hall Featuring Sponsors & Partners

Explore Innovations and Connect with Industry Leaders

Our Exhibit Hall will host a diverse range of sponsors and partners showcasing the latest in regulatory affairs, technology and services. Attendees can:

  • Discover new tools and Solutions
  • Engage with company representatives
  • Build valuable professional relationships

Featured Topics

Pharmaceuticals and Biologics
Medical Device

Comparing and Contrasting Regulatory Strategies between FDA and EMA

Presenter
Sean Russell

Corrective and Preventive Actions

Presenter
Rusty Lusk

Early Regulatory Strategy for Drug / Combination product

Presenter
James Wabby

What Went Wrong

Presenter
Jerry Valenti

Testing Strategist for Biotech

Presenter
Michael Yakes

SaMD and AI

Presenter
Jay Vaishnav

International Drug Registrations

Presenter
Silvia De Morales

FDA Submissions

Presenter
David Pudwill

Global Risk Management

Presenter
Virginia Suveiu

Challenges in Interlinking Clinical Evaluation & Risk Management

Presenter Sabitha Aboo

Annual Conference Agenda

Reception Sponsored by

Cencora and PharmaLex logos

5pm-7pm

Complimentary refreshments

Network

Meet the presenters

Learn more about selects research projects

Accomodations

OCRA-DG has arranged for discounted accommodations for the Annual Conference’s attendees. Discover Hotel Zessa, the premier Orange County hotel near John Wayne Airport.

 

Enjoy vibrant energy, renovated rooms, and the signature DoubleTree cookie. Just click on the button below and confirm the Catering Code 0002972307 to book your room.

Free shuttle service available to and from the hotel and Santa Ana John Wayne Airport. 

Thank you to our Sponsors to help make this happen!