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Risk Management of Medicinal Products: REMS and RMP - Need for Harmonization Within the ICH Region?

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Overview 

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


This webinar will present the "state of the art" of risk minimization strategies. The requirements for REMS and EU-RMP will be outlined, and practical advice for their implementations will be offered.

The presenters focused on detection, assessment and minimization of risks. Critical safety data during the development of a pharmaceutical drug, the importance of epidemiology and natural history of disease as well as statistical considerations in analyzing safety data will be presented. Methods for risk minimization will be presented with a focus on methods for provision of information to health care professionals and patients, development of educational material and risk minimization strategies.

The webinar also highlighted the REMS, which may be requested by the FDA at any point of the life cycle of a drug or biological product, if safety data warrant it. In contrast to the EU-RMP the REMS is not mandatory for all approved drugs but rather requires a safety signal warranting the implementation of a REMS. Vivid examples for the required medication guide, communication plan, elements to assure safe use and implementation system will be presented. A focus will be placed on REMS assessments after approval by the FDA. Efficient strategies for REMS life cycle management and evaluation of supporting document submissions will also be outlined.

Lastly, the presenters focused on the requirements for an EU RMP. Of special interest are the defaults outlined by GVP Module V concerning safety specification, pharmacovigilance plan, and risk minimization strategies. An overview on how to evaluate the need for risk minimization activities will be presented. The considerations for an efficient risk management system and arrangements in drug safety which ensure an adequate risk minimization and protection of the public health will also be outlined. Similarities and dissimilarities with REMS will be elaborated and discussed. Finally, the impact of European Risk Minimization Strategies and EU pharmaceutical package on risk management processes will be outlined and prospects for REMS and RMP harmonization will be critically examined.

Who Should Attend 

Professionals involved in:

  • Clinical Safety and Pharmacovigilance
  • Safety Regulation
  • Risk Evaluation and Mitigation Strategies

Learning Objectives 

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

  • Discuss how to detect risks and perform risk assessments
  • Determine how to select risk minimization and mitigation measures
  • Examine how to compile REMS and EU-RMPs

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Wednesday, Sep 18, 2013

  • 10:00AM - 11:59PM

    Risk Management of Medicinal Products: REMS and RMP - Need for Harmonization Within the ICH Region?

    Speaker(s):

    • Risk Management - the Perspective of the European Generic Pharmaceutical Industry
      Irene Bognar-Steinberg, PhD
      Head of Medical Affairs
      Helm AG, BU Pharma, Germany
    • Risk Management of Medicinal Products: REMS and RMP – Need for Harmonization within the ICH Regions?
      Reingart Bordel, DrSc, MS
      Senior Manager Pharmacovigilance and Regulatory Affairs
      Dr. Ebeling & Assoc. GmbH, Germany
    • Risk Management of Medicinal Products: REMS and RMP – Need for Harmonization within the ICH Regions?
      Leonardo Ebeling, MD, PhD
      Managing Director
      Dr. Ebeling & Assoc. GmbH, Germany

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 Standard Individual
$250.00

Non-Member

NonMember Standard 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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