Overview of Health Product Regulation, September - November 2017

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Take Your Career to the Next Level

Are you interested in learning more about regulatory affairs?  Learn the concepts of regulation of drugs, devices, biologics, healthcare technology, and clinical research investigation?  Overview of Health Product Regulation will provide you with a broad understanding of regulators, regulations, and their interplay with industry across product development stages. 

The course will cover a 6-week semester and you will receive 3.0 graduate credits that you can apply towards a certificate or master’s degree in Regulatory and Clinical Research Management from Regis College or a certificate of completion

Regis College’s online teaching platform, Moodle, will enable participants to access reference materials, slides, articles, and other documents provided by the instructor. In-class attendance is encouraged, however the option to attend virtually in real-time is available for those who are unable to for one or two sessions.

CourseTopics Include:

  • Organization, structure, and regulations of the FDA
  • Industry overview and regulations
  • Knowledge and tools used to regulate the drug, biologic, and device industries
  • Pre and post marketing regulations
  • Role of manufacturers, distributors, and providers as related to health products
  • Public health promotion

Target Audience:

  • Professionals interested in expanding knowlledge in the regulatory field from all sectors of the biotech, pharma, device, contract research organizations, and life sciences industries, including: sales, marketing, HR, legal, manufacturing, business development, finance, management, government relations, IT, safety, tech transfer offices
  • Patient advocacy groups, disease foundations
  • Policy makers, lobbyists, attorneys
  • Consultants, public relations specialists, journalists
  • University administrators, research institute support staff

Instructor: Michael Drues, PhD

Mike is the President of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical and biotechnology companies including stimulating and innovative educational programming, creative regulatory strategy and completive regulatory intelligence, regulatory submission design, FDA presentation preparation and defense, brain-storming sessions, prototype design, product development, benchtop and animal testing, clinical trial design, reimbursement, clinical acceptance, business development and technology assessment.  He received his bachelor's degree, master's degree and doctorate from Iowa State University, all in biomedical engineering.  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.  Mike is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs.

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Price

  • $1,695 for MassBio Members
  • $1,985 for Non-Members
  • $1,500 for Non-Profits
  • $0 for MassBio Administrative Use Only

Date

September 27 - November 1, 2017
Wednesday evenings, 6:00 - 9:00 pm

Space is Limited

Only 29 spots remain

Category

Corporate Professional Development

Location

Regis College

Level of Knowledge

Beginner

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