November 2024 SOCRA Source Journal - Journal - Page 88
FDA Conference:
Clinical Trial Requirements, Regulations, Compliance and GCP Conference
Jointly Sponsored
IN-PERSON
NOVEMBER 6 & 7, 2024 | NEW ORLEANS, LA
MARCH 19 & 20, 2025 | DALLAS, TX
JUNE 25 & 26, 2025 | MINNEAPOLIS, MN
Workshop registration fees:
Standard Rate - Member Fee - $575
Standard Rate - Non-Member Fee *- $650
Federal Government Employee Rate - Member Fee - $450
Federal Government Employee Rate - Non-Member Fee*- $525
FDA Employee Rate - FEE WAIVED
* Non-Member Fees include a non-refundable one-year membership in SOCRA
Goal: SOCRA is pleased to offer this conference that is jointly sponsored with OBIMO Program Divisions of the U.S. Food and
Drug Administration. This conference on FDA’s clinical trial requirements is designed to aid the Clinical Research Professional’s
understanding of the mission, responsibilities and authority of the FDA and to facilitate interaction with FDA representatives.
Objective: This two-day conference is intended to share information among FDA representatives and the regulated community,
to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the
research professional’s product development experience. The program will focus on the relationships among the FDA and clinical
trial staff, investigators and IRBs. The workshop will highlight three areas that present challenges to sponsors and investigational
sites: FDA Clinical Research Requirements, Enhancing Success through Communication and Financial Incentives, and Assuring
Con昀椀dence in Clinical Research.
Learning Objectives - The attendee should be able to:
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Discuss the role of the FDA district of昀椀ces, how they
are structured and their responsibilities
Describe what FDA expects in a pharmaceutical
clinical trial
Discuss the science, regulation and assessment of
adverse events
Discuss how studies with investigational devices differ
from those with drugs and biologics
Describe the regulations that apply to the informed
consent process
Discuss how the ethical principle of justice underlies
responsible participant selection
Describe the IRB regulations and FDA’s mechanisms to
assure compliance
Describe the parameters included in regulations
applying to electronic signatures
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Describe how the FDA can assist members of the
research community in their efforts to 昀椀nd information
and understand FDA regulations
Discuss the responsibilities of the clinical investigator
Describe how Pre-IND meetings and the FDA meeting
process assist the research goal
Describe the sponsor/investigator’s legal responsibilities,
additional duties and concerns
Describe how the FDA’s Center for Biologics regulates
research
Discuss the array of actions taken when research fails to
meet standards enforced by the FDA
Describe how the FDA’s Of昀椀ce of Science and Health
Coordination, Good Clinical Practice Program, promotes
con昀椀dence in clinical research
SOCRA designates this educational activity for a maximum of 12.75 Continuing Education Credits
for SOCRA CE, Nurse CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 12.75 AMA PRA Category 1 Credit(s)™.
Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing
Medical Education to provide continuing medical education for physicians.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the
American Nurses Credentialing Center's Commission on Accreditation.
SOCRA Course Series 700
88
SOCRA SOURCE © November 2024
