Greater Los Angeles Area

Welcome to the SOCRA Greater Los Angeles Area Chapter page. Information for the latest meetings are below. If you have any questions, please reach out to the Chapter Chairperson or the SOCRA office at chapters@socra.org.

SOCRA Greater Los Angeles Chapter 

AUGUST CHAPTER MEETINGS

Date: 8/25/2025 (Monday)
Time: 10:00 am to 11:00 am (Pacific Time) | 1:00 pm to 2:00 pm (Eastern Time) 
Location: Via Zoom

Title / Topic: Pregnant and Lactating Individuals in Clinical Research - FDA’s Authority and Moving from Exclusion to Inclusion

Learning Objective(s):

1. Learn a brief history of events that led to the earliest principles and requirements that excluded pregnant and lactating individuals from clinical research.
2. Become familiar with the current ethical principles, regulatory guidelines and legal requirements that govern the inclusion of pregnant and lactating individuals in clinical research, with a focus on clinical research involving FDA-regulated drugs and devices.
3. Discuss the challenges pregnant and lactating individuals and their providers face in navigating ClinicalTrials.gov

Speaker: Sarah Wicks, JD, MPH

Sarah Wicks is an associate at Hyman, Phelps & McNamara, P.C. where she advises drug and biologics companies on a wide range of FDA regulatory and compliance matters throughout the product development and commercialization process. She helps clients navigate human subject protections, clinical trial conduct, product strategies, and interactions with the FDA. She also provides guidance on advertising, promotion, and labeling, ensuring compliance with FDA regulations, and offers expertise in managing internal investigations, responding to FDA inspection observations, and defending against enforcement actions. A strong advocate for the patient voice in drug development, Sarah is dedicated to incorporating patient perspectives into the regulatory process. She plays a key role in planning externally-led patient-focused drug development meetings and works with patient organizations to organize patient listening sessions and adjunct scientific workshops. Her efforts bridge the gap between regulatory frameworks and the needs of the patient community, ensuring that drug development aligns with patient priorities and experiences. By combining her regulatory knowledge with a commitment to patient-centered approaches, Sarah helps clients navigate the complex landscape of drug development while advocating for meaningful patient engagement.

Meeting Link:
SOCRA Greater Los Angeles at City of Hope is inviting you to a scheduled Zoom meeting.
https://cityofhope.zoom.us/j/97048355588?pwd=5PVWgwVPJdv4aGLikccYuku4zZQi0N.1
Password: 155658
Or  by telephone:
+1 415 762 9988 (US Toll)
+1 646 568 7788 (US Toll)
Meeting ID: 970 4835 5588
Password: 155658

Continuing Education (CE): SOCRA members may claim 1.0 CE credit per hour of education. SOCRA members will receive Certificates of Attendance within two weeks after the completion of the event.

 All SOCRA members and non-SOCRA members are welcomed.

Please share this announcement with your colleagues.