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Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation

Nov 6 2014 11:00AM - Nov 6 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


Series Overview

These core lectures will focus on the essentials of clinical pharmacology in drug development. They will outline basic pharmacological and therapeutic principles that show how drugs get into the body, how they produce their effects, what happens to them in the body, and how evidence of their therapeutic effect as well as unwanted effects are assessed. The information is vital to an understanding of how drugs are to be used safely and effectively. The principles will be illustrated by practical applications offered by examples from real experience.

Five lectures will cover the following topics:

  • Pharmacokinetics
  • Pharmacodynamics
  • Principles of Modeling and Simulation
  • Determining the Safe First Human Dose
  • Assessment of QT Prolongation

Part 5: Assessment of QT Prolongation

Assessment of arrhythmogenic potential of a new drug entity via assessment of the impact on the QT interval of the ECG has become a standard feature of drug development since ICH E14 guidance was issued in 2005.

This session will focus on the following topics:

  • Brief overview of the ICH E14 and the Thorough QT Study (TQTS);
  • A discussion on the timing of TQTS in drug development and impact of TQTS in subsequent drug development
  • What type of QT assessment and analysis is recommended in Phase 1 and Phase 2 (early drug development)
  • A discussion on recent developments in QT assessment whereby a combination of non-clinical and early clinical QT assessment with concentration response modeling could potentially obviate the need for TQTS

Who Should Attend 

The target audience for these webinars includes physicians, pharmacists, nurses, and scientists, as well as their regulatory and commercial colleagues, from industry, academia, medical centers, and health authorities, who are involved in all phases of drug development and safety evaluations throughout the product lifecycle.

Learning Objectives 

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

  • Discuss the timing of assessment of QT prolongation in drug development
  • Discuss the recent developments in QT assessment

Special Offers 

Series Discount Available*

Buy 2 webinars in this series
and save 10%
Buy 3 or 4 webinars in this series
and save 15%
Buy the whole series
and get one webinar free

*Order must be placed in one transaction for savings to be applied

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
CustomerService@diahome.org

Agenda Details
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Technical Requirements 

Click here for minimum system requirements.

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
CustomerService@diahome.org

Faculty Or Speakers 

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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. The Drug Information Association designates this educational activity for up to 1.5 contact hours or .15 continuing education units (CEUs).
0286-0000-14-077-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).

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.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Unit
• Program Management Certificate Program: 1 Elective Unit
For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Part 5: Assessment of QT Prolongation ACPE 1.50 0.150
Part 5: Assessment of QT Prolongation IACET 1.50 0.200

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 Thursday, November 20, 2014.

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.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

Series Discount Available*

Save when you purchase two or more webinars in this series.
Buy two webinars in this series and save 10%
Buy three or four webinars in this series and save 15%
Buy all five webinars in the series and receive one part for free.

*Order must be placed in one transaction for savings to be applied.


  • Individual registration is a license for ONE internet login allowing one viewer.
  • 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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