Drug Information Association Logo

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

| Online

« Back to Listing


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

Archived Webinar Details
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


Previous Next


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


    • 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
Group Plus


Charitable Nonprofit/Academia Member Individual
Member Government Individual
Member Standard Individual


Charitable Nonprofit/Academia Nonmember Individual
NonMember Government Individual
NonMember Standard Individual
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.

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

Register Online

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.

« Back to Listing Back To Top