interested in learning more about Regulatory Affairs in the biotech and life sciences industries?

Welcome to SDRAN

SDRAN is a nonprofit organization dedicated to supporting our members through various educational and development programs for medical device and pharmaceutical industry professionals.

UPCOMING EVENTS

2026 OPEN HOUSE Kick-Off Networking Event - Feb 24, 2026 (5:30pm - 8:00pm)
Feb 24, 2026

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February 24th, 2026 | 5:30pm to 8:00pm  - Location:  Ki’s Restaurant, 2591 S. Coast Hwy, Cardiff, CA  92007

We could all us use a dose of sunshine right now!  Come enjoy a relaxed evening of networking, delicious bites, & painting-plus a chance to discover what SDRAN has in store for this season, from educational programs & RAC study groups to mentoring opportunities and more.   Admission includes appetizers, libations, & an instructor lead paint class. Registration required. Must register by Feb 22nd
Details
Data Happens : Leveraging Real-World Evidence in an Evolving FDA Landscape
Thursday, March 12, 2026
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How to Prepare for a Regulatory Inspection: Planning for Success

Data Happens: Leveraging Real-World Evidence in an Evolving FDA Landscape

Guest Speaker: Stephen Weber, MD

Former-FDA Expert Consultant at NDA Partners Assistant Professor at Johns Hopkins University
Time Program
5:30 – 6:00 PM Light Dinner and Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 6:10 PM Introduction of Speaker
6:10 – 7:00 PM Speaker Presentation
7:00 – 7:20 PM Q & A
7:20 – 7:30 PM Closing Remarks
The regulatory landscape for medical products is rapidly evolving as regulators and industry alike recognize the value of Real-World Evidence (RWE) and Real-World Data (RWD) in enhancing regulatory decision-making... FDA has removed key barriers for real-world evidence and emphasizes a fit-for-purpose framework focused on data quality, relevance, and methodological rigor. Updated guidances provide clearer expectations for submissions and encourage early FDA engagement. In this presentation, Dr. Weber will examine how the evolving FDA landscape is shaping RWE use across product types and highlight practical considerations for sponsors. Speaker Biography: Stephen Weber, MD is a former FDA medical reviewer with extensive experience evaluating the safety and effectiveness of medical products across the regulatory lifecycle...

Pricing – Online Registration (ends Tuesday, March 10, 2026)

Registrant Type In-Person Price Virtual Event Price
Member $25.00 $15.00
Lifetime $25.00 $15.00
Non-Member $35.00 $25.00

Location & Attendance Options

This event is offered both In Person and Virtually. When you register, you will choose your attendance.
  • In Person: ZLAC Rowing Club, 1111 Pacific Beach Drive, San Diego, CA 92109. Pre-registration required; no registration at the door.
  • Virtual: Zoom link will be sent 1–2 days before the event.
Register Now & Choose Your AttendanceQuestions? Email [email protected]
Location & Attendance Options This event is offered both In Person and Virtually. When you register, you will choose your attendance. In Person: ZLAC Rowing Club, 1111 Pacific Beach Drive, San Diego, CA 92109. Pre-registration required; no registration at the door. Virtual: Zoom link will be sent 1–2 days before the event.
Location Options
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Mission & Vision

Dedicated to educational instruction and support to individuals for their professional development regarding the laws, regulations, and standards established by international, federal and state government regulatory agencies as they apply to the development, manufacture, distribution, and/or use of drugs, biologics, and medical devices.

Education

SDRAN offers a variety of helpful and affordable programs for those interested in preparing for the device and pharma RAC tests. Additionally, our classes are popular with professionals who wish to keep abreast of changes and people looking to learn more about the regulatory process. Classes are offered entirely online. SDRAN offers a variety of financial incentives to class participants.

Mentoring

The SDRAN Mentoring Program is designed to help promote the career growth and development of our members, and to strengthen the regulatory affairs profession. 

General Info

Our Mailing Address:
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

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MEMBERSHIP

The SDRAN membership fee is:
$55.00 for 12 months

JOIN / RENEW / UPDATE HERE

Email

[email protected]

Get In Touch

MAILING ADDRESS
SDRAN
P.O. Box 927595
San Diego, CA 92192-7595

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