Fourth Annual MDG Educational Seminar – 5:30 to 9PM on May 11 and 18, 2010

MEDICAL DEVICE REGULATORY AFFAIRS FOR NON-REGULATORY PROFESSIONALS: What do non-regulatory professionals need to know?
Presented by Dr. Michael Drues

Click here for a downloadable Course Description & Agenda.

Click here to Pre-Register for the Course

Seminar Overview and Objectives:

Geared for both experienced medical device professionals as well as those new to the industry, this seminar is designed specifically for non-regulatory professionals who need a better understanding of the regulatory requirements necessary to bring new medical devices to the market. This unique seminar demonstrates important regulatory requirements and concepts through actual product case studies discussions emphasizing not simply following regulations but asking do the regulations make sense and what to do when they don’t!

Major medical device approval pathways are presented with a discussion of the advantages and challenges of each. Pre- clinical and clinical trial phases will be discussed highlighting how issues relate back to product design and development. Important topics such as pediatric devices, off-label use and medical device direct-to-patient advertising will also be discussed. Differences between medical devices, drugs and biologics will be discussed with emphasis on the emerging area of combination products. Some differences between domestic vs. international approvals will be touched upon. Multiple examples of medical devices and procedural videos are presented in an interactive format with a discussion of what they do well and where improvements can be made. Suggested length: 2 three-hour sessions.

Upon completing the seminar, each attendee will be able to:

• Understand the major regulatory requirements that apply to medical devices
• Learn to work more effectively with regulatory personnel and the FDA
• Be able to anticipate questions from FDA reviewers
• Learn to design a regulatory strategy to minimize product approval delays
• Appreciate the goals and challenges of medical device clinical trials
• Understand the similarities and differences between medical devices, drugs and biologics
• Recognize the advantages and challenges of combination products
• Identify opportunities for future growth

Who Should Attend?

This seminar is designed especially for non-regulatory professionals involved in the design, development, and manufacture of medical devices. Those working in research and development, manufacturing, quality, business development, sales and marketing, legal, business and accounting, field service and related areas will all benefit from this seminar.

About the Instructor

Michael Drues, Ph.D., is President of Vascular Sciences 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), Regis College (Boston) 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 Devices, Designing Gastrointestinal & Urinary Devices, Designing Better Medical Devices: Begin with the body in Mindä, Minimally Invasive Technologies, Combination Products and Convergence, Overview of Biotechnology, Emerging Trends in the Medical Device Industry™, Big Picture Issues in Clinical Trials™ and Regulatory Affairs for Non-Regulatory Professionals.

For additional information, please contact Dr. Michael Drues at mdrues@vascularsci.com or call (508) 887-9486.