February 2024 SOCRA Source Journal - Journal - Page 88
FDA Conference:
Clinical Trial Requirements, Regulations, Compliance and GCP Conference
Jointly Sponsored
JUNE 13 TO 15, 2023 I VIRTUAL
Workshop registration fees:
Standard Rate - Member Fee - $175
Standard Rate - Non-Member Fee *- $250
Federal Government Employee Rate - Member Fee - $75
Federal Government Employee Rate - Non-Member Fee*- $150
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 three-day virtual 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 sessions 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 Confidence in Clinical Research.
Learning Objectives - The attendee should be able to:
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Discuss the Role of the FDA District Offices, how they are
Structured and their Responsibilities
Describe how the FDA’s Office of Science and Health
Coordination, Good Clinical Practice Program, Promotes
Confidence in Clinical Research
Describe what FDA Expects in a Pharmaceutical Clinical
Trial
Discuss how Studies with Investigational Devices differ
from those with Drugs and Biologics
Discuss the Science, Regulation and Assessment
of Adverse Events
Describe how FDA’s Center for Biologics Regulates
Research
Discuss how the Ethical Principle of Justice underlies
Responsible Participant Selection
Discuss the Responsibilities of the Clinical Investigator
x
x
x
x
x
x
x
Describe how the FDA Small Business Representatives
assist the Research Community
Describe the Sponsor/Investigator’s Legal Responsibilities,
Additional Duties and Concerns
Describe how Pre-IND Meetings and the FDA Meeting
Process assist the Research Goal
Describe the Parameters included in Regulations Applying
to Electronic Signatures
Describe the IRB Regulations and FDA’s Mechanisms to
Assure Compliance
Describe the Regulations that Apply to the Informed
Consent Process
Discuss the Array of Actions taken when Research Fails to
Meet Standards Enforced by the FDA
SOCRA designates this educational activity for a maximum of 11.25 Continuing Education Credits forSOCRA CE, Nurse
CNE, and Physician CME.
SOCRA designates this live activity for a maximum of 11.25 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 © May 2023