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Generic Drug Labeling Proposed Rule and Safety Updates

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Overview 

Continuing Education credits are not available for the archived offering. 

This archive will be available for purchase through May 31, 2015.
Archive duration: 1 hour 35 minutes


Recent rulings in the Supreme Court cases of Pliva v Mensing (2011) and Mutual Pharmaceuticals v. Bartlett (2013) have resulted in a legal loophole favoring generic manufacturers.  Federal labeling regulations were found to preempt state tort suits against generic manufacturers, thereby disenfranchising the rights of consumers to seek legal action if generic labeling does not adequately reflect safety warnings. In the pursuit of public health, the FDA released a press announcement in November 2013 on a proposed rule that would “speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.” This new rule would close this legal loophole to ensure consumer safety but would result in a significant change to the regulatory practices of the pharmaceutical industry. This webinar will focus on the expectations of the proposed rule and the potential impact it will have from the brand and generic perspectives.

Who Should Attend 

Intermediate to Advanced Clinical Safety Professionals who are involved in:

  • Advertising and Promotion
  • Regulatory Affairs
  • Labeling
  • Medical Writing
  • Quality
  • Legal

Learning Objectives 

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

  • Discuss the proposed labeling ruling and its impact on industry labeling practices
  • Identify potential obstacles that both opponents and proponents of the rule have discussed during the public comment period

Contact Information 

Printable Registration Form

Registration Questions and Technical Support
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

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

Technical Requirements 

Click here for minimum system requirements.

Technical Support
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
CustomerService@diahome.org

Presenter(s) 

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Agenda  

Day 1 Friday, May 16, 2014

  • 7:00AM - 11:59PM

    Generic Drug Labeling Proposed Rule and Safety Updates

    Speaker(s):

    • Ethel Holtzclaw
      Regulatory Affairs Manager
      Pharmalink Consulting, United States
    • Proposed Rule on Post-Approval Drug Safety Labeling Variations
      Michael A. Swit, JD
      Special Counsel
      Duane Morris, LLP, United States
    • Gary L Yingling, JD
      Partner
      Morgan, Lewis & Bockius LLP, United States

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

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
$350.00
Registration Information

Printable Registration Form

This archive will be available for purchase through May 31, 2015.
Archive duration: 1 hour 35 minutes

  • Individual registration is a license for ONE internet login allowing one viewer.
  • 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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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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