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The Case of the New England Compounding Center: Learning from the Tragedy

Nov 19 2013 11:00AM - Nov 19 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


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?

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 Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1. 703.506.3275.

This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Unit

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
The Case of the New England Compounding Center IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, December 3, 2013.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits and Certificate Program units are not available for participation in the archived version of the webinar.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$995.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
NonMember Academia Individual
$175.00
NonMember Individual
$295.00
Group Discounts

  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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