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Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

Nov 3 2014 8:30AM - Nov 4 2014 4:30PM | DIA Global Center 21 Dupont Circle NW, Suite 300 Washington, DC 20036

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Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities.   Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. The course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on exercises and discussion.

Course Level: Advanced

What You Will Learn 

  • How data mining fits into an overall system of product safety risk management.
  • How to read and interpret outputs from automated data mining analyses.
  • How to prioritize and evaluate signals from data mining.
  • Create an efficient, multidisciplinary process for signal detection and management that meets regulatory standards.

Who Should Attend 

This course is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities.  The course will also benefit participants who make risk management decisions based on signal detection including professionals who work in:

  • Clinical safety and pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory affairs
  • Benefit-risk management
  • Information technology supporting pharmacovigilance activities

Learning Objectives 

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

  • Lead the implementation of an integrated signal detection and management project
  • Identify strengths and limitations of specific data sources for signal detection and evaluation
  • Interpret outputs from automated quantitative signal detection methods (data mining results)  
  • Discuss setting up triage and prioritization procedures for potential safety signals 
  • Apply structured medical assessment to safety signal evaluation
  • Design governance processes for signal escalation, decision-making, action and communication
  • Implement a safety signal tracking system
  • Integrate safety signal management into overall risk management

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Training Course Location
DIA Global Center
21 Dupont Circle NW, Suite 300
Washington, DC  20036

Hotel Information
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 16, 2014, or until room block is filled). Attendees must make their own hotel reservations, but only after receiving written confirmation from DIA. Please reference the Drug Information Association Training Course when booking your stay.

Suggested hotel across from DIA:

A) The Dupont Circle Hotel
1500 New Hampshire Avenue NW
Washington, DC  20036
P. 202.483.6000

Room block rate of $189

Room Rate Includes:
Complimentary Wi-Fi access in all guestrooms
Complimentary usage of the health club facility for all attendees
Use of Business Center at no charge for all guests

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

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199


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Continuing Education 

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

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer 1.3 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 Safety and Pharmacovigilance Certificate Program: 4 Core Units
• Regulatory Affairs Certificate Program: 8 Elective Units

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

Name Credit Type Max Credits CEU
Advanced Signal Detection - Tools, Triage, Evaluat IACET 13.25 1.300

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 attend the activity, sign-in at the DIA registration desk each day of the activity, and complete the online credit request process through My Transcript at www.diahome.org . 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 two weeks after the last day of the activity.
Please note: If you do not sign-in, you will not receive CE credit as partial credit will not be awarded.

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

Registration Fees 


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


Charitable Nonprofit/Academia Nonmember Individual
NonMember Government Individual
NonMember Standard Individual
Group Discounts\Registration

 Printable Registration Form

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.

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.

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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