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

Apr 23 2014 11:00AM - Apr 23 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


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

Agenda Details
Meredith Kaganovskiy, CMP,
Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199
Meredith.Kaganovskiy@diahome.org

Agenda Details and 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
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

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:
•Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Units
• Regulatory Affairs Certificate Program: 1 Elective Units

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

Name Credit Type Max Credits CEU
Strategies for Successfully Introducing REMS 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, Mayl 7, 2014. Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

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

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.

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