Combination Products: Clinical Benefits, Regulatory Issues & Manufacturing Challenges
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 3, 2014):
- What are the clinical benefits of combination products compared to monotherapies – are they right for you?
- How are combination products currently regulated – Tips and tricks to use current pathways to your advantage.
- The top regulatory pitfalls to avoid, and tips to get your products on the right track to approval and the manufacturing stage.
Part II (April 10, 2014):
- What are the manufacturing challenges of combination products, i.e., sterility, stability, shelf-life, packaging, etc.?
- Building efficiencies while improving quality.
- What is the future of combination products including case studies from tissue engineering, nanotechnology and more!
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.
Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical and biotechnology companies.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering and Biotechnology at several universities and medical schools. He regularly teaches graduate courses in regulatory affairs and clinical trials, clinical trial design, medical device regulatory affairs and product development, combination products, pathophysiology, medical technology, translational medicine and biotechnology.