2023-2024 SOCRA Annual Report - Flipbook - Page 21
SOCRA 2021 ANNUAL REPORT
EDUCATIONAL OPPORTUNITIES
2020 - 2021
QUALITY MANAGEMENT CONFERENCE
CLINICAL RESEARCH / CLINICAL SCIENCE COURSE
This interactive conference assists
research professionals in
understanding, developing, and
implementing quality management
systems (QMS) in the conduct of
clinical trials. This conference provides
attendees with new information, tools,
and real life examples to help
Abby Statler, PhD, MPH, MA, participants navigate the components
of quality management - quality
CCRP, Director, Research
planning, quality control, quality
Quality and Safety,
assurance, and quality improvement.
Dartmouth-Hitchcock
Medical Center
Program Chairperson
The Clinical Science Course was first offered in 1995, as
SOCRA’s flagship educational program. Since its
inception, it has been revised and enhanced to meet
the constantly changing needs of our members. This
program is divided into 2 modules; a
regulatory/procedural module and a medical/scientific
module, to maximize its value to course attendees.
Attendees may elect to attend one (either) or both
modules.
Course objectives will be accomplished through lecture and
practical application facilitated by clinical research professionals
with expertise in the area. Information will be presented and
discussed regarding the development and implementation of
quality management systems in the conduct of clinical trials
according to FDA Regulations and International Council on
Harmonisation (ICH) guidance.
Topics include:
Elements in Risk Management and Quality Systems
Best practices in assessing and mitigating risk in clinical trial
project management
Develop and implement a Quality Assurance (QA) Program
for Investigator-Initiated Trials (IITs)
Panning and implementation of real life examples of quality
initiatives
Essentials of conducting an audit/inspection ready study
Best strategies on audit/inspection close out processes
CAPA development and implementation
Management of serious breaches and non-compliance
Impact of system non-compliance, sanctions, and fraud
Top QA and QC trends
This program guides attendees
through all the components of
quality management - quality
planning, quality control, quality
assurance, and quality
improvement - with new
information, tools, and practical
examples for application.
Module I is the Regulatory / Procedural Module
consisting of sessions pertaining to: Drug Development
Process, Clinical Pharmacology, Adverse Event
Reporting, Budgeting, Good Clinical Practice, ICH
Guidelines, Informed Consent, Preparing for a GCP
Audit, Regulatory Affairs and IRBs, IND/NDA, Research
Ethics, and Source Documentation and
Administration.
Module II is the Medical / Scientific Module consisting
of sessions pertaining to: Ethical Issues in Clinical Trials,
Anatomy and Physiology, Cell Biology, Genetics,
Clinical Laboratory Science, Epidemiology, and
Research Statistics.
Faculty from esteemed institutions lead this program.
SOCRA OFFERS A ROBUST PORTFOLIO OF LIVE IN-PERSON
AND VIRTUAL CONFERENCES, WORKSHOPS, AND COURSES
TO KEEP YOU AT THE FOREFRONT OF THE INDUSTRY AND
SUPPORT YOUR CONTINUING EDUCATIONAL GOALS.
WE ARE CONSTANTLY ADDING NEW PROGRAMMING, AND
LOOKING TO YOU, OUR MEMBERS, TO HELP US PLAN
WHAT'S NEXT.
EMAIL US AT OFFICE@SOCRA.ORG
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