2023-2024 SOCRA Annual Report - Flipbook - Page 20
SOCRA 2021 ANNUAL REPORT
EDUCATIONAL OPPORTUNITIES
2020 - 2021
DEVICE RESEARCH & REGULATORY CONFERENCE
This conference reviews
fundamental concepts and
current issues relating to device
research compliance, research
development, and clinical
investigation for Device Research
in the current regulatory
environment. An optional halfday program on Device Basics for
Kathi Durdon, MA, CCRP
participants new to device
Executive Director, Central
New York Biotech Accelerator research precedes the main
conference.
Program Chairperson
DEVICE HALF DAY WORKSHOP: DEVICE RESEARCH BASICS
PEDIATRIC CLINICAL TRIALS CONFERENCE
Lisa Benson, BS, CCRP,
President, Pediatric Clinical
Research Consultant, LLC
Program Chairperson
The optional preconference workshop, designed for those
new to research or for those who would like to have a
refresher on the device clinical research regulations and
guidances, offers a comprehensive overview for those
interested in device clinical research and serves as a
building block for the more advanced general session.
DEVICE RESEARCH: GENERAL SESSION
This 2-day advanced conference includes experts involved
in the research and development of safe and effective
medical devices. Topics include: 510(k) Program Update,
Device Total Product Life Cycle (TPLC) Case Study from FDA
experts, Conducting Device Trials in Ascending Markets, IVD
trials, IRB Roles and Responsibilities, ISO 14155, as well as
presentations from innovation, communication and human
factors experts.
This program presents
advanced concepts by industry
experts involved in the research
and development of safe and
effective medical devices.
Amanda Galster, MPH, CCRP
Executive Director, PASCRECOVER, University of
Arizona Health Sciences
Program Chairperson
OFFERED
VIRTUALLY AND
IN-PERSON
This two day program reviews
regulatory, financial, and ethical
components of conducting clinical
trials in the pediatric population.
This conference features information
and discussion regarding the
administration of clinical trials
according to FDA Regulations and
International Conference on
Harmonisation (ICH) regarding
vulnerable populations.
SOCRA's Pediatric Conference
provides attendees with information,
tools, and real life examples to help
participants navigate the evolving
landscape of pediatric research.
This conference highlights the
following areas:
Unique Challenges of Conducting
Clinical Trials in a Pediatric Setting
Regulatory Considerations in the
Pediatric Population
Challenges Faced in Recruitment,
Enrollment, and Retention
Development of Pediatric
Research Studies
Budgeting and Contracting
Project Planning and
Management
Monitoring, Auditing
and Compliance
Study Closeout
This program provides
attendees with information,
tools, and real life examples to
help participants navigate the
evolving landscape of pediatric
research.
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