Let’s face it - regulatory affairs is a critical business function for regulated industries that is a misunderstood, highly complex, and ever-evolving profession.
Regulatory costs are rising, regulatory burdens are increasing, global regulatory matters are becoming more complex, and qualified candidates are scarce.
The mismanagement of information can cost your company time, money and resources.
In this free 60-minute webinar, our presenter, James W. Gianoutsos, Director of QA/RA at Carmell Therapeutics, Founder of RIMSYS Regulatory Software, and Principal Consultant at Regality Consulting, LLC discusses the current regulatory intelligence landscape and how to properly manage information from a practical and innovative software solutions standpoint.
specifically, YOU WILL learn:
- True Regulatory Intelligence Management (RIM) – What is Regulatory Intelligence Management and how should it be properly utilized?
- Regulatory Affairs Profession – How has regulatory affairs changed over the course of the last ten years and where is the profession headed?
- The Sales and Regulatory Love/Hate Relationship – Why do your sales and regulatory teams need to get on the same page?
- Building a Business Case to New Market Entry - How can this simple strategy save your company a lot of heartburn?
- How to Manage It All – What is the importance of information and intelligence management and how can innovative software (i.e. RIMSYS Regulatory Software) save your business time, money and embarrassment?
Who should attend?
-
Medical Device Industry Executives
-
Regulatory Affairs Professionals and Management
-
Quality Professionals and Management
-
Clinical Affairs Professionals and Management
-
R&D Engineers and Management
About the presenter:
James W. Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industry. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices.
James has worked comprehensively with products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants.
James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) from the University of Pittsburgh.
