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Off-label Marketing Regulation in the Wake of the US v. Caronia Decision

Jan 23 2013 11:00AM - Jan 23 2013 12:30PM | Online

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Overview 

In this webinar legal, industry and regulatory experts will discuss the recent US v. Caronia decision.  The 2nd US Circuit Court of Appeals, in its decision on US v. Caronia, may reset the legal boundaries between the FDA and pharmaceutical manufacturers’ rights to disseminate off-label information about approved drug products. The decision, overturning the criminal conviction of pharmaceutical sale representative, Alfred Caronia, may be the most significant commercial free speech decision by a federal appeals court in many years and sets up a possible hearing before the US Supreme Court.

This DIA webinar will present the facts of the case and the implications for the industry. Panelists will discuss possible appeals, plus questions on how the decision will impact settlements on "false claims" acts prosecutions, and possible rules by FDA in profession and consumer advertising, including social media.  Off-label marketing using comparative effectiveness and economic studies will also be discussed.

While the full impact of Caronia remains to be seen, this webinar will explore the dimensions of the conversations and decision on off-label marketing regulation that will occur in the coming months and years.

Who Should Attend 

  • Advertising & Promotion
  • Clinical Safety/Pharmacovigilance
  • Medical Communications
  • Medical Writing
  • Comparative Effectiveness/Health Technology Assessment/Evidence-based Medicine
  • Pricing/Reimbursement
  • Public Policy/Law/Corporate Compliance
  • Regulatory Affairs
  • Research and Development/Strategic Issues

Learning Objectives 

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

  • Examine US v. Caronia decision
  • Discuss the implications for the industry 
  • Evaluate the impact on off-label marketing regulation

Contact Information 

Registration Questions
Elizabeth Espich, Customer Service Associate
Phone +1.215.293.5802
Fax +1.215.442.6199
Elizabeth.Espich@diahome.org

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

Event Logistics
JoAnn Boileau, Event Planner
Phone +1.215.442.6175
Fax +1.215.442.6199
JoAnn.Boileau@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 1.5 contact hours or .15 continuing education units (CEU’s). Type of Activity: Knowledge; 0286-0000-13-044-L04-P

ACPE Credit Request Update
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

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.

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

Name Credit Type Max Credits CEU
Off-label Marketing Regulation in the Wake of the ACPE 1.50 0.150
Off-label Marketing Regulation in the Wake of the 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, February 6, 2013.

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

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

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

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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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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