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Overview

Continuing Education credit or Certificate Program units are not available for Archived Webinars


With the recent deaths due to fungal meningitis associated with contaminated products from the New England Compounding Center, there has been much discussion of how this happened and how it can be avoided. While these are important questions, we must be careful how new regulation may have even broader implications. For example, with the growing interest in pharmacogenomics, a.k.a. personalized medicine, how may the law of unintended consequences apply? If we create new regulation to prevent such tragedies from occurring, what are the broader implications for the future? It’s one thing to measure how many are harmed due to a product that is not safe enough, but how do we measure how many are harmed because they don’t have access to a product because we have increased the regulatory burden and manufactures simply do not develop it?

In this webinar, participants will gain a much better understanding not just of the facts of this case, but more importantly the why’s and the potential ramifications beyond traditional compounding to pharmaceutical and medical device manufactures now and in the future. Topics of discussion will include:

FDA Regulations: Pharmaceutical companies are regulated by the FDA and must meet strict facility and quality control standards to ensure that their products are safe. Compounding pharmacies are regulated by state boards of pharmacy; thus, each state will have a different set of standards. Will standards for drug quality assurance and regulatory enforcement be consolidated?

Ramification of Potential Regulations: On the surface, the NECC case would seem to impact only the compounding industry, but the ramifications could go far beyond compounding and do affect the pharmaceutical and medical device industries in ways yet to be considered, specifically with new technologies. Will proposed regulation slow innovation?


This Archive Webinar will be available until November 30, 2014.

Who should attend?

This webinar is designed for professionals involved in:

  • Compliance activities for pharmaceutical, medical device, and biologics manufacturers
  • Regulatory affairs
  • Clinical safety

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Describe the facts of the case around the New England Compounding Center
  • Discuss the potential ramifications beyond traditional compounding to pharmaceutical and medical device manufactures

Contact us

Registration Questions
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org