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Regulatory and Legal Landscape Impacting Medical and Scientific Communications

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Overview 

Continuing Education credit or Certificate Program units are not available for Archived Webinars

This archived webinar will be available for purchase through June 30, 2014. Broadcast time is 1 hour 27 minutes.


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  • How the 2011 FDA draft guidance entitled “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Device” has impacted industry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  • Comments to "Draft Guidance for Unsolicited Requests for Off-Label Use & Docket No FDA-2011-N-0912"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

For information on this archived webinar
DIA North America
Carolyn Callahan
Phone +1.215.442.6194
Carolyn.Callahan@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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Agenda  

Day 1 Friday, December 13, 2013

  • 7:00AM - 11:59PM

    Regulatory and Legal Landscape Impacting Medical and Scientific Communications

    Speaker(s):

    • Regulatory and Legal Landscape Impacting Medical and Scientific Communications
      Mary K. Sendi, PharmD
      Director, Medical Information
      Pfizer Inc, United States
    • Stuart Sowder, JD,PharmD,MBA
      Vice President, External Medical Communications
      Pfizer Inc, United States
    • Jeffrey K Francer, JD,MPA
      Vice President & Senior Counsel
      PhRMA, United States
    • Kristin Graham Koehler, JD
      Partner
      Sidley Austin LLP, United States

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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