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Generic Drug Labeling Proposed Rule and Safety Updates

May 15 2014 11:00AM - May 15 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


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 Day of Event
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
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
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Technical Requirements 

Click here for minimum system requirements.

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

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).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

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
Generic Drug Labeling Proposed Rule and Safety Upd 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 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 Thursday, May 29, 2014.

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

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

  • 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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