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CDER Town Meeting: Safety Hot Topics

Jan 29 2014 11:30AM - Jan 29 2014 1:00PM | Online

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This webinar will be broadcast in Eastern Daylight Time (EDT)

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 and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199

Event Logistics
Benjamin Zaitz, Event Planner
Phone +
Fax +1.215.442.6199

Technical Requirements 

Click here for minimum system requirements.


Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Monday-Friday 8:30AM-8:00PM ET


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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 1.5 contact hours or .15 continuing education units (CEU’s). 0286-0000-14-037-L04-P; Type of Activity: Knowledge

ACPE Credit Request Update
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1.703.506.3275.

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.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 1 Elective Unit
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Unit
• Regulatory Affairs Certificate Program: 1 Elective Unit

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

Name Credit Type Max Credits CEU
CDER Town Meeting: Safety Hot Topics IACET 1.50 0.200
CDER Town Meeting: Safety Hot Topics ACPE 1.50 0.150

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 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, February 12, 2104.

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.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE

Registration Fees 

Other Fees

Government (Full Time) Individual
Charitable Nonprofit/Academia Individual
Group Site
Group Plus


Member Individual


NonMember Individual
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.

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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