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Five-Part Series on Fundamentals of Clinical Pharmacology For Drug Development - Part 3: Principles of Modeling and Simulation

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Overview 

Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through November 5, 2015.


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 3: Principles of Modeling and Simulation

Clinical scientists are increasingly relying on modeling and simulation (M&S) approaches as a way to understand the underlying biology and sources of variability driving drug response, to describe the relationship between drug exposure and biomarkers or drug effects, and to predict the outcome of potential trial designs.  M&S facilitates the integration of data, knowledge and assumptions over the lifespan of a drug, and allows pharmaceutical scientists to make rational, quantitatively-based decisions throughout a drug’s development.

This session will focus on the following topics:

  • What is modeling? What is simulation?
  • How can M&S help quantify and understand disease biology and drug mechanism of action
  • How is M&S used to understand the sources of between-subject variability in disease, exposure, andclinical response?
  • How can M&S be used to design a more efficient and effective, and less costly, clinical trial?

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:

  • Define modeling and simulation
  • Discuss how modeling and simulation can be used in clinical trials

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

*Includes Archived Webinars in this series. Order must be placed in one transaction for savings to be applied.

Contact Information 

Printable Registration Form

Registration Questions
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

Information about Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

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Presenter(s) 

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Agenda  

Day 1 Friday, Sep 05, 2014

  • 11:00AM - 11:59PM

    Five-Part Series on Fundamentals of Clinical Pharmacology For Drug Development - Part 3: Principles of Modeling and Simulation

    Speaker(s):

    • Stacey Tannenbaum
      Director, Pharmacokinetics, Modeling, & Simulation; Global Clinical Pharmacology
      Astellas, United States
    • Dean Bottino, PhD
      Scientific Director, Translational Modeling & Simulation Clinical Pharmacology
      Takeda, United States
    • Fundamentals of Clinical Pharmacology - Principles of Modeling and Simulation
      Presentation - All Speakers
      United States

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*
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

*Includes Archived Webinars in this series. 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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