2024 Annual Conference Brochure - Flipbook - Page 9
THURSDAY, SEPTEMBER 28, 2023
PRECONFERENCE SEMINARS
Device Research Regulatory Basics
SOP Development and Implementation
This engaging workshop is all about medical devices – we may
talk a little about pharmaceuticals, but only when comparing
differences. Who should attend this workshop? If you are new
to conducting medical device studies, or maybe you work for a
startup company and need to know how to get your product
cleared or approved for market – you might want to attend this
workshop. Or you work in a clinical research, regulatory or
quality affairs department – you might want to attend this
workshop. You could be a study coordinator, study monitor,
research nurse, statistician, data manager or principal
investigator and have an interest in medical device research –
you might want to attend this workshop. You may want a
refresher on topics specific to medical device to include
compliance with Good Clinical Practice (GCP) regulations, nonsignificant risk and significant risk studies, risk management,
investigator initiated studies, monitoring process, human
factors engineering integration and usability testing – you
might want to attend this workshop. We’ll generate active
discussion in challenging areas, promote examples through
case studies, and provide a comprehensive overview of medical
device research and regulations.
Presenters: Kathi Durdon, BA, MA, Executive Director, Central
New York Biotech Accelerator
Angie Rock, MBA, CCRP, Director, Clinical Operations,
BIOTRONIK, Inc
Discuss the fundamental concepts and current issues in the
development and implementation of an effective Standard
Operating Procedure (SOP) program for clinical sites. Basic
principles, as well as challenges, will be introduced through
lecture, discussion and