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Introduction to Signal Detection and Data Mining

Sep 29 2014 12:00PM - Oct 2 2014 1:30PM | Online

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Overview 

This online training will be broadcast in Eastern Time (ET)


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

Featured Topics 

  • 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 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event

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

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
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

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).

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 .6 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 6.00 0.600

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:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line 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.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.

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

Agenda  

Day 1 Monday, Sep 29, 2014

  • 12:00PM - 1:30PM

    Part 1: Background and Regulations

Day 2 Tuesday, Sep 30, 2014

  • 12:00PM - 1:30PM

    Part 2: Approaches/Methods

Day 3 Wednesday, Oct 01, 2014

  • 12:00PM - 1:30PM

    Part 3: Safety Signal Methods and Examples

Day 4 Thursday, Oct 02, 2014

  • 12:00PM - 1:30PM

    Part 4: Signal Detection Management System

Registration Fees 

Other Fees

Group Site
$2250.00

Member

Charitable Nonprofit/Academia Member Individual
$450.00
Member Government Individual
$450.00
Member Standard Individual
$895.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$535.00
NonMember Government Individual
$535.00
NonMember Standard Individual
$985.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course 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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