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Strategies for Successfully Introducing REMS to Your Organization: From Development and Implementation and Internal and External Evaluation

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Overview 

Continuing Education credits are not available for archived webinars

The archive will be available for purchase through October 31, 2014
Duration: 1 hour 22 minutes


Does my organization have the infrastructure to support REMS?  How do I engage key stakeholders and gain their support? How do I reconcile and synchronize companywide and regulatory FDA required reporting?  These are just a few of the big questions surrounding the successful implementation of a Risk Evaluation Mitigation Strategies (REMS).

This webinar will present strategies for designing, implementing, and evaluating REMS.  Case examples will illustrate building consensus, establishing urgency, as well as identifying cross-functional partners and leadership. Throughout the webinar possible gaps and potential challenges during the implementation process will be discussed. Questions on how to balance company-required reporting and regulatory-required evaluation will be shared.  

The overall purpose of this webinar is to educate participants on strategic development and operational planning over the life cycle of REMS from initial design through implementation and evaluation.

Who Should Attend 

Professionals involved in:

  • Clinical Safety and Pharmacovigilance
  • Medical Affairs
  • Project Management
  • Quality Assurance
  • Quality Risk Management
  • Regulatory Affairs
  • Risk Evaluation/Management and Mitigation Strategies
  • Safety Regulation
  • Strategic Planning

Learning Objectives 

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

  • Describe key components of a strategic plan for successful introduction and integration of REMS into an organization
  • Identify and engage key stakeholders to participate in REMS design and implementation
  • Identify key considerations for planning and building an infrastructure for ongoing evaluation

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

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.

Presenter(s) 

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Agenda  

Day 1 Friday, Apr 25, 2014

  • 7:00AM - 11:59PM

    Strategies for Successfully Introducing REMS to Your Organization: From Development and Implementation and Internal and External Evaluation

    Speaker(s):

    • Strategies for Successfully Introducing REMS to Your Organization: From Development and Implementation to Internal and External Evaluation
      Juliane Mills, MPH, MS
      Associate Director Scientific Affairs, Late Phase and Clin. Diagnostic Services
      PRA, International, United States
    • Mary Willy, PhD
      Associate Director, Division of Risk Management, OMEPRM, OSE, CDER
      FDA, United States
    • Nancy D. Smith, PhD
      Adjunct Professor
      Temple University, FDA Alumni, United States

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Charitable Nonprofit/Academia Member Individual
$175.00
Member Government Individual
$125.00
Member Standard Individual
$250.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Government Individual
$125.00
NonMember Standard 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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