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CDER Town Meeting: Safety Hot Topics

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Overview 

Continuing Education credit is not available for archived webinars.

This archive will be available for purchase through July 28, 2014.
Archive duration: 1 hour 28 minutes


In this interactive webinar, participants will submit questions regarding safety to senior leadership from the US FDA Center for Drug Evaluation and Research through an anonymous, computerized Q&A function. The topics that will be discussed will depend on the audience and on the areas that are of current importance within the CDER Community.  Presentations will include:

Postmarketing Safety Surveillance and Pharmacovigilance in CDER at FDA
This presentation will describe CDER’s current safety surveillance and pharmacovigilance practices for signal detection and management.
Presenter: Cindy Kortepeter, PharmD, Associate Director, Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, CDER, FDA
 
Update on Initiatives to Standardize the Design and Assessment of REMS
This presentation will provide updates from recent public meetings about methods to standardize the design and assessments of REMS.
Presenter: Claudia Manzo, PharmD, Director, Division of Risk Management, Office of Surveillance and Epidemiology, CDER, FDA
 
Drug Safety Communications – Insights on How FDA Determines What Safety Issues to Communicate and When
The presentation will describe CDER’s general principles and procedures for communicating about drug safety issues.
Presenter: Laura Pincock, PharmD, MPH, Team Lead Analyst, Safety and Risk Communication Team, Division of Health Communications, Office of Communications, CDER , FDA


If you would like to submit a question prior to the webinar, email Melissa.Buchanan@diahome.org.

 

Who Should Attend 

This webinar is designed for professionals involved in:

  • Clinical safety and pharmacovigilance
  • Medical product safety assessment
  • Pharmacoepidemiology
  • Clinical research
  • Regulatory affairs
  • Risk management strategy development
  • Quality assurance
  • Compliance
  • Medical information
  • Labeling
  • Brand teams
  • Safety data management/analysis

Learning Objectives 

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

  • Discuss current “hot topics” on drug safety issues in CDER, including signal evaluation,  management, and communication
  • Describe new safety-related guidances and initiatives by CDER

Contact Information 

Printable Registration Form

Registration Questions
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

Questions about this Archived Webinar
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Wednesday, January 29, 2014

  • 11:30AM - 11:59PM

    CDER Town Meeting: Safety Hot Topics

    Speaker(s):

    • Mwango Kashoki, MD,MPH
      Associate Director for Safety, Office of New Drugs, CDER
      FDA, United States
    • Postmarketing Safety Surveillance and Pharmacovigilance in CDER at FDA
      Cindy Kortepeter, PharmD
      Associate Director, Division of Pharmacovigilance I, OSE, CDER
      FDA, United States
    • Update on Initiatives to Standardize the Design and Assessment of REMS
      Gary H. Slatko, MD
      Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
      FDA , United States
    • FDA Drug Safety Communications (DSCs)
      Laura L. Pincock, PharmD,MPH
      Team Lead Analyst, Safety and Risk Communication Team, OC, CDER
      FDA, United States
    • Min Chen, MS,RPh
      Acting Director, Division of Pharmacovigilance I, OSE, CDER
      FDA, United States
    • Overview of Active Surveillance of Medical Products with Mini-Sentinel
      Patrick Archdeacon, MD
      Medical Officer, Division of Medical Policy Development, OMP, CDER
      FDA, United States
    • Theresa A. Toigo, MBA,RPh
      Associate Director for Drug Safety Operations, OCD, CDER
      FDA, United States
    • Sally M. Seymour, MD
      Deputy Director of Safety/DPARP/OND/CDER
      FDA, 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 Individual
$250.00

Non-Member

NonMember 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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