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Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges - part 1

Instructor: Michael Drues
Product ID: 701158
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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This Medical device training will guide you through Combination products and overview of clinical benefits, regulatory issues and manufacturing challenges.

Description

Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!

Despite the controversy, the best known example of a combination product is the drug-eluting stent. However, the drug-eluting stent is also an extremely primitive example of a combination product. The quintessential example of a combination product is tissue engineering. Why? Because we have cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).

It’s hard to imagine more of a combination product than that – or can we? During this two-part interactive workshop, participants will be exposed to examples of combination products on the market, under development and on the drawing board.

What Attendees will Learn
  • What is a combination product? How are they regulated now and what will likely change in the future?
  • How do the cultural and philosophical differences between CDER, CBER and CDRH impact the FDA approval process?
  • What value does the FDA Office of Combination Products (OCP) really provide? What does the OCP do that’s not on their web page?
  • How can we use the request for designation (RFD) and primary mode of action (PMOA) concepts to our advantage in bringing products to market more efficiently?
  • What are the challenges of convergence? How can drug, biotech and medical device companies communicate when they don’t speak the same language?
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Biotech, Pharmaceutical, and BioPharma. The employees who will benefit include:
  • Research & Development
  • Manufacturing Profesional
  • Regulatory Professional
  • QA managers and personnel
  • Legal
  • Marketing

Instructor Profile:
Michael Drues, Ph.D., is President of Vascular Sciences (www.vascularsci.com) in Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr.Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. 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).

Dr. Drues is an Adjunct Professor of Medicine & Biotechnology at Northeastern University (Boston), Steven’s Institute of Technology (Hoboken), Boston College (Boston), University of Wisconsin (Madison), Drexel Medical School (Philadelphia) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and short courses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include: Designing Cardiovascular, Peripheral and Neurovascular Devices Designing Gastrointestinal and Urinary Devices Minimally Invasive Technologies Combination Products: Medical Devices Meet Drugs, Biologics & Beyond™ Overview of Biotechnology Emerging Trends in the Medical Device Industry™ Big Picture Issues in Clinical Trials™ Regulatory Affairs for Non-Regulatory Professionals.

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