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Regulatory and Legal Landscape Impacting Medical and Scientific Communications

Dec 11 2013 11:00AM - Dec 11 2013 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET) 


In a regulated industry such as ours, regulatory guidance documents from the Food and Drug Administration (FDA), corporate integrity agreements (CIAs) from the Office of Inspector General (OIG), and legal decisions affecting the pharmaceutical industry may substantially impact how you work in medical and scientific communications.

This webinar will provide answers to many of your questions about:

  • How the 2011 FDA draft guidance entitled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Device” has impacted industry interactions with consumers and healthcare providers
  • How the recent CIA  and State AG settlements have impacted medical and scientific communications
  • How industry is ensuring health care professionals have access to objective, relevant/credible information  necessary for informed treatment decision making and patient care while maintaining compliance with FDA regulations
  • The importance of recent judicial opinions on FDA regulation of off-label communications, especially U.S. v. Caronia, as well as the potential impact on medical and scientific communications
  • How these regulatory and legal decisions and/or the guidance have restricted, enhanced, or built upon current  internal operating procedures and practices across externally facing medical communication functions such as Medical Information, Field Based Medical, Publications Management, Medical Education Grants- regionally and globally

Featured Topics 

  • FDA’s regulatory and statutory framework governing medical and scientific communications
  • Comments to "Draft Guidance for Unsolicited Requests for Off-Label Use & Docket No FDA-2011-N-0912"
  • Legal decisions affecting the pharmaceutical industry
  • How industry is ensuring health care professionals have access to credible medical information needed for informed treatment decisions

Who Should Attend 

Professionals involved in:

  • Medical Communications
  • Medical Information Call Center
  • Medical Affairs
  • Medical Science Liaisons
  • Medical Writing

Learning Objectives 

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

  • Discuss the regulatory and statutory framework governing FDA’s regulation of medical and scientific communications
  • Discuss recent judicial opinions on the FDA’s regulations of off-label communications, especially U.S .v. Caronia, and whether they will require that FDA re-visit its regulatory framework
  • Discuss the policies and procedures the Office of Inspector General (OIG) and State Attorney General is requiring of Medical Information, Medical Science Liaisons, and Publications to have in place based on recent Corporate Integrity Agreements (CIA) and State AG settlements
  • Discuss the impact that these regulatory and legal decisions have on the pharmaceutical industry and medical communicators [Field Based Medical, Medical Information, Publications, Medical Education] - practical interpretation and internal implications
  • Discuss how the pharmaceutical industry is ensuring HCPs access to relevant and credible medical and scientific information needed for educated and effective treatment decision making and patient care with necessary risk assessments and mitigation planning

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@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
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

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. The Drug Information Association designates this educational activity for up to 1.5 contact hours or .15 continuing education units (CEUs).
0286-0000-13-097-L04-P; Type of Activity: Knowledge

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; +1.703.506.3275.

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.

DIA’s Certificate Program Statement
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
Regulatory and Legal Landscape ACPE 1.50 0.150
Regulatory and Legal Landscape 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 Thursday, December 26, 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 the DIA website at www.diahome.org/CE

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 Industry Individual
$250.00

Non-Member

NonMember Industry 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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