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Introduction to Signal Detection and Data Mining

Apr 1 2014 8:30AM - Apr 1 2014 5:00PM | The Hub Cira Centre 2929 Arch Street Philadelphia, PA 19104

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Overview 

This training course will review approaches to the implementation of signal detection and data mining as part of your pharmacovigilance operations. The requirement for companies to perform signal detection is mandatory in Europe and highly recommended in the US.  Many simple techniques can be applied to the generation and review of potential signals, which can also be augmented by the application of sophisticated data mining algorithms.

Topics discussed will include signal assessment, use of signal triage algorithms, compliance with FDA guidance as specified in “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,” March 2005, and the timing and frequency of signal detection, triage, and data mining runs.

Course Level: Beginner

What You Will Learn 

  • Why signal detection is needed
  • Regulatory requirements
  • Approaches to signal detection
  • Good Pharmacovigilance practices
  • Data mining fundamentals
  • Introduction to the Bayesian Confidence Propagation Neural Network (BCPNN)
  • Proportional Reporting Ratio (PRR)
  • Multi-item Gamma Poisson Shrinker (MGPS)
  • Managing signals
  • Signal detection strengthening and management
  • Signal detection process and operation
  • Risk management basics in the US and the EU

Who Should Attend 

Professionals who work in:

  • Clinical safety and pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory affairs

Learning Objectives 

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

  • Define signal detection and differentiate the stages of a signal management system
  • Describe the regulations and guidance documents driving the practice of signal detection in US and EU
  • Discuss various methods of qualitative and quantitative signal detection and data mining
  • Recognize how signal management systems can be organized and implemented within their company

Special Offers 

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

Hotel & Travel 

Training Course Location
The Hub Cira Centre:
2929 Arch Street, Mezzanine Level
Diesel Room
Philadelphia, PA 19104
Phone: 267.519.5260

Hotel Information
Attendees must make their own hotel reservations, but only after receiving written confirmation from DIA.
The Hub Cira Centre is attached to 30th Street Station in Philadelphia.

Suggested nearby hotels

A) The Sheraton University City
3549 Chestnut Street
Philadelphia, PA 19104
p. 888.627.7071

B) The Hilton Inn at Penn 
3600 Sansom Street
Philadelphia, PA 19104
p. 215.823.6240
The Hub Rate: Guest to contact Sabrina Cooper
p. 215.823.6240 e. Sabrina.cooper@hilton.com

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

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Faculty 

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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), 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 .7 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 Elective Units

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

Name Credit Type Max Credits CEU
Introduction to Signal Detection and Data Mining IACET 6.50 0.700

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, 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 

Member

Charitable Nonprofit/Academia Member
$470.00
Member Government
$470.00
Member Standard
$940.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$695.00
NonMember Government
$695.00
NonMember Standard
$1165.00
Group Discounts

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.

Future Dates & Locations

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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