Risk Modeling in Drug Development - (2 days)

Duration: 2 full days

Minimum of 6 people and maximum of 15

Course overview

Learn how to use quantitative risk analysis (QRA) and risk modeling to improve decision-making in the drug development process from early drug development to clinical trials. For an article discussing the applications and benefits of using QRA and risk modeling in the pharmaceutical industry, read the following paper that EpiX Analytics co-authored for the magazine of the American Association of Pharmaceutical Scientists:

http://www.epixanalytics.com/downloads/AAPSNewsCoverArticle_EpiXAnalytics_2011.pdf.

- Understand the most important modeling techniques, methods (including Monte Carlo simulation) and software tools available to perform and interpret risk analyses in the drug development process;

- Learn and practice key risk analysis techniques that will allow you to support more informed and better decisions making in pre-clinical stages as well as clinical trials.

- Gain expert insight from EpiX Analytics; a world renowned risk analysis consultancy and training company with vast experience working with the nation's top pharmaceutical companies as well as numerous smaller, more specialized pharmaceutical (branded and generics) firms.

Course content
Course format

The course runs from 09:00 to 17:00 each day, but registrations on the first day begin at 8:30am. Morning and afternoon coffee and lunch are provided. The course will be delivered in English.

Who should attend?

Decisions made throughout the entire drug development and commercialization process are fraught with uncertainties. Quantitative risk analysis (QRA)—also called stochastic modeling, risk modeling, or quantitative risk assessment—aims to improve decision making by taking into account variability and uncertainty and providing insight into probabilities related to decisions.

The Risk Modeling in Drug Development course will be beneficial for all analysts, scientists, managers, and consultants involved in the pharmaceutical industry who would like to gain a greater insight into how quantitative risk analysis can improve decisions in drug development from pre-clinical stages to clinical trials.

Previous risk modeling experience is helpful, but certainly not necessary. The course is designed to be beneficial for both experienced and non-experienced Excel and risk modelers.

Prerequisites and required software

Participants will be primarily using Crystal Ball (by Oracle, v 7.0 or newer) or alternatively @Risk (by Palisade, version 5.0 or newer) together with Microsoft Excel to solve the exercises. However, participants can also choose to use another Monte Carlo package of their choice.It is important that participants have basic working knowledge of Excel. However, no prior experience using Crystal Ball/@RISK or other simulation tools is required. Trial versions of @Risk can be found from Palisade's website herehere and trials of Crystal Ball can be downloaded from Oracle's websiteOracle's website. As the trial licenses last 15 days, participants should install it only a few days before the course. In addition to Crystal Ball and @Risk and MS Excel, participants are required to bring laptops with Microsoft Word and PowerPoint installed.

In case participants prefer to use a particular software package, please let us know and we will make all example models and exercises available in the relevant software package.

Free ModelAssist

ModelAssist is a comprehensive risk analysis training reference and is free of cost. This reference tool provides an in-depth explanation of all of the risk analysis concepts, techniques and methods introduced in this course and greatly complements the course material. ModelAssist can be downloaded directly from our website

Teaching philosophy

All of EpiX Analytics' courses aim to help the participants understand risk analysis from the bottom-up, which is achieved through a relaxed, informal and interactive environment using plenty of examples and hands-on exercises where students apply and adapt what they have learned.

Social events

Our training courses provide an opportunity to develop or extend your professional network. We therefore arrange optional fun, interactive social events which take advantage of local attractions, cuisine, and culture. All social events are included in the course fee.

Lodging and transportation

Course participants must arrange their own accommodations. However, we will be happy to provide information and alternatives for your travel arrangements. After you complete your registration, please let us know that you will need our help.

 Registration discounts

Early registration - 10% off registration (register and pay 30 days before course start date)
*  Government - 5% off registration (Proof of eligibility requested after registration)
 Student - 25% off registration (Proof of eligibility requested after registration)
Please send an email to training@epixanalytics.com to obtain a discount Code for either the Early Registration, Government, or Student discount.
3 registrants - 17% off total registration
4 registrants - 25% off total registration
5+ registrants - please contact us for special discount rate

Please note that discount rates cannot be combined. Discounts exclude online courses via statistics.com and joint courses offered with other institutions.

Please send an email to training@epixanalytics.com to inquire about courses not currently scheduled.

Registration details

Start Date To be confirmed
Individual Price $1,490.00
$1,490.00

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Brief History of EpiX Analytics

EpiX Analytics was founded in 2003 in Princeton, NJ under the Vose Consulting name, and among its offerings it included specialized software to perform Monte Carlo simulations. Read More >>