Combination products offer an attractive solution to some complex therapeutic problems. Additionally, they offer the promise of a sustainable business model as an estimated 30% of all new healthcare products under development today are combination products. However, the challenges of navigating the regulatory approval process and manufacturing these often complex products can present a barrier to market that is often difficult to overcome. Furthermore, confusion surrounding regulatory governance of novel combination products leaves many prospective manufacturers asking the question “where do I start?”
This course will provide you with the foundational understanding to effectively navigate the regulatory process while safely and efficiently manufacturing high-quality combination products. Additionally, you will gain an understanding of the roles of regulatory bodies in the US, plus receive a glimpse into the future of combination products and opportunities on the horizon.
By attending this two-part, interactive online course, you will learn the following:
Part I (April 11, 2016):
Part II (April 29, 2016):
Geared for both experienced medical device professionals as well as those new to the industry, this course is designed for those who need a better understanding of the current regulatory requirements surrounding combination products. This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities. Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all benefit from this webinar.
David Amor, MSBE, CQA is a medtech/biotech consultant and mobile health entrepreneur who founded Medgineering, a company focused on remote compliance, regulatory & quality systems consulting for larger companies and start-ups alike. A graduate of the prestigious Innovation Fellows program at the University of Minnesota’s Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and a 35 Under 35 Entrepreneur in 2015 by MN Biz Magazine. Recently, David co-founded and helped launch Remind Technologies, a Texas based mobile health company developing smartphone based remote medication management system (www.remind-technologies.com). He also is co-inventor on several issued utility patents and co-pioneered a disruptive e-consulting platform for the medtech and pharma industries called QuickConsult (www.myquickconsult.com). Lastly, David also serves as an adjunct professor at St. Cloud State University in Maple Grove, MN where he teaches courses on risk management and design control. The current focal points of his consulting practice are specializing in risk management, design controls, combination products and mHealth.