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Global Regulatory Strategy Panel Discussion
Program Speakers:
Jennifer Grodberg, PhD, RAC-US
Regulatory Affairs Consultant
Jennifer Grodberg Regulatory Consulting
Frank Pokrop
Sr. Director of Regulatory Affairs
QuidelOrtho
Jeff Yuen
Founder/President and CEO
Jeff Yuen & Associates
Event Agenda:
DATE: Wednesday, 24 January 2024
TIME: 5:30 – 6:00 PM Light Dinner
6:00 – 6:05 PM Welcome and Announcements
6:05 – 8:00 PM Program Panel with Q&A
LOCATION: This event is being offered both IN PERSON and VIRTUALLY. When you register, you will be able to choose how you will attend the event. No walk-ins allowed. Please register for this event by the registration deadlines.
If you register to attend IN PERSON, please join us at:
Neurocrine Biosciences, Inc.
12790 El Camino Real
San Diego, CA 92130
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- Click here to register for this event (IN-PERSON attendance option)
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If you register to attend VIRTUALLY, you will receive the Zoom link 1-2 days before the event.
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- Click here to register for this event (VIRTUAL attendance option)
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Program Details
Manufacturers of pharmaceuticals, biologics, and medical devices are marketing products worldwide, requiring regulatory professionals to develop a comprehensive global regulatory strategy. Come and hear directly from our panelists (experts in pharma, medical devices, and biologics) on how they approach global regulatory strategy from both the pre-market and post-market perspective.
Speaker Biographies:
Jennifer Grodberg, PhD, RAC-US (Jenny) is a regulatory affairs consultant with 30 years’ experience in the pharmaceutical industry and 20 years’ experience in regulatory affairs. Her regulatory experience spans the pre-IND enabling phase through NDA submission, including FDA inspections and Advisory Committee Meetings, with international regulatory experience supporting global clinical trial conduct and successful pediatric investigational plan agreement.
She previously held positions as Sr. Vice President of Regulatory Affairs and Program Management at Forge Therapeutics, VP of Regulatory affairs at VenatoRx Pharmaceuticals, Senior Director of Regulatory Affairs at Trius Therapeutics, Inc. and Associate Director of Regulatory Affairs and Drug Development at TargeGen Inc. Jenny has a PhD in Microbiology and completed postdoctorates at both the Weizmann Institute of Science in Israel, and Harvard Medical School. She held an Instructor position at Harvard Medical School before moving into the pharmaceutical industry.
Jenny received Regulatory Affairs Certification in 2007, is a Fellow of the American Medical Writers Association (AMWA) and past-president of the AMWA Pacific Southwest Chapter. She served 10 years as chair for the San Diego Regulatory Affairs Network Mentoring Program and 4 years on the SDRAN Board of Directors as Vice President, Mentoring Program.
Jenny currently serves on the Board of Mama’s Kitchen, a nonprofit organization providing free medically-tailored meals to the critically ill in San Diego County. She also volunteers with the Assistance League of Rancho San Dieguito, an all-volunteer, community-based organization serving individuals affected by trauma, violence and poverty.
Frank Pokrop has worked in the drug and medical device industries for more than 20 years and has obtained these certifications: CSQE, CISA, CPGP and RAC. Frank is a senior director of regulatory affairs at Quidel in San Diego where he leads the implementation of the IVDR regulation. His background includes worldwide submissions and product approvals, recall management, leading global compliance and auditing programs, product launches, vigilance reporting, and he has worked in manufacturing for both drugs and devices. At UC San Diego he has: (1) Taught courses on medical device submissions, and, (2) Served on the IRB for 4 years. He is a member of the Board of Directors for RAPS. He is currently a member of the FDA Committee on Hematology products. He volunteered at the San Diego Regulatory Affairs Network (SDRAN) for 10 years serving as President and VP of programs and he lives in Carlsbad with his wife and a female chocolate Labrador.
CDR Jeff Yuen is a well-respected domestic and international speaker with over 35 years of compliance and regulatory experience; Jeff was a peace officer/investigator with the State of California, Food and Drug Branch and a Consumer Safety Officer for the US FDA. During his tenure with the US FDA, he was rapidly promoted to the rank of Commander in the US Public Health Service while serving as a member of the following teams:
- FDA’s Pacific Regional Biotech Team (pre-cursor to ORA Team Biologics);
- Los Angeles District Pre-Approval Manager and Drug Team Leader; and
- Foreign Inspection Cadre.
CDR Yuen served as District Drug Team Leader and Drug Pre-Approval Manager during his time with US FDA. CDR Yuen specialized in both high priority drug (PAI) and biologics (ELA and BLA) inspections. He is widely recognized as a CGMP and compliance expert by industry, CDER and CBER Office of Compliance in sterile drug manufacturing particularly with regard to inspection of biotech products, aseptic filling, quality systems, and process validation.
CDR Yuen is the recipient of numerous US Public Health commendation and achievement medals including a “Hammer Award” presented by Vice President Al Gore’s Office for his participation and leadership in the area of innovative biotechnology/FDA industry outreach programs. Since leaving the FDA in 1998, CDR Yuen has succeeded in launching a well-recognized and well-respected independent consulting firm. Jeff Yuen & Associates, Inc. is comprised of a unique balance between former FDA National Experts, specialists, investigators, chemists, biologists and microbiologists AND former industry quality systems, compliance and GXP regulatory experts.
Since leaving the FDA and building his well-respected consulting firm, he has served as an acting transitional executive at several companies: Head of Quality at Althea Technologies now Ajinomoto Althea (San Diego), Executive Vice President of Global Quality for AAI Pharma / Cambridge Major Laboratories now Alcami (North Carolina), Chief Quality Officer for Alexion Pharmaceuticals, Inc. (New Haven, CT) and Executive VP for Hanmi Pharmaceuticals (Korea).
CDR Yuen has become well-recognized worldwide for his unique ability to work well with others in Operations and QA. Well-respected for his mentoring, coaching and love for teaching, CDR Yuen excels at bringing out the best in companies. With a passion for operational excellence and performance, he has often served as the catalyst for organizational and cultural “change” resulting in effective quality systems which emphasize the importance of “right first time”; and proper root cause investigations and meaningful CAPA initiatives. CDR Yuen’s leadership and insights along with his endless energy and special charisma have influenced, shaped, and prepared many companies and their leaders for success during this challenging era of technological advancements and stricter compliance expectations.
CDR Yuen possesses a BS in Biological Sciences from UCI, a Masters in Public Health from UCLA, and an MBA from National University and was recognized as “Distinguished Alumni for the School of Biological Sciences – University of CA, at Irvine. CDR Yuen was a former President of the PDA – Southern California Chapter and has sat on several executive advisory boards, was a member of IVT Board, BIOCOM’s FDA Committee, UCI’s Biotechnology Advisory Board, UCI Extension Advisory Board, and a former faculty member of PDA-TRI and member of PDA’s Biotech Technical Advisory Board. He currently is a current member of the Dean’s Advisory Board and Volunteer Clinical Professor with the UCI School of Pharmacy and Pharmaceutical Sciences.
Registration Information:
No walk-ins allowed. Please register for this event by the registration deadlines.
Click here to register for this event (IN-PERSON attendance option)
Click here to register for this event (VIRTUAL attendance option)
Contact
Pricing Registration
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Registrant Type |
In-Person price (Registration ends Monday, 22 January 2024) |
Virtual price (Registration ends Tuesday, 23 January 2024)
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Member |
$20 |
$10 |
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Lifetime |
$20 |
$10 |
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Non-member |
$30 |
$20 |
Cancellation Policy
There will be no refunds for cancellations.
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