Certara Professional Courses and Certifications

July-September 2024 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description This course will teach you the theory and application of compartmental modeling, using the Phoenix Model. You will learn how to create Maximum Likelihood PK models using Phoenix WinNonlin software. You will evaluate competing structural models and choose the best residual error model for the data.  In addition to using the built-in "library" models, you will learn to use the Graphical Model Editor to customize PK models.  You will learn how to use simulations to make decisions, such as evaluating different dosing regimens with respect to safety and efficacy.  Upon successful completion of this course, you will receive an e-badge as a PK/PD Modeler using Phoenix WinNonlin.  This certification is valid for 3 years. Pricing Cost - $550 (Academia $275, Africa/India $150) If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you work on a permanent basis in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Course Format, Language and Dates This course is a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course.  This course will be delivered in English. This course will be offered in July, August, and September 2024.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 30 July and finishing on 3 September.  We will record sessions and post the recordings for those who are unable to attend live.  You will have access to the recordings for 3 months following the last session of the course. There are also five weekly office hour sessions, in which gives a more extended period for asking and answering questions.  We have two options for people in different time zones:  Office Hour Option A is offered at times most convenient for participants in the Americas, Europe, and Africa.  They are on Fridays at 11 AM New York (GMT-4).  Office Hour Option B is offered at times most convenient for participants in Asia/Pacific.  They are on Tuesdays at 2 PM Brisbane (GMT+10).  (FYI, 2 PM Tuesday in Brisbane is late Monday evening in New York.) Practice Exercises There are five practice exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis.  Each practice exercise contains a quiz that you must pass with at least a 60% score, although you can repeat each quiz as many times as you need to pass it.  Certification Exam This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as a PK/PD Modeler using Phoenix WinNonlin version 8.3, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with Maximum Likelihood Models in Phoenix WinNonlin. Exam Details Software:  There is no requirement to have the Phoenix WinNonlin™ software installed to take the exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix WinNonlin 8.3. Grading: To successfully earn the PK/PD Modeler certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing each part of the test. The exam tests 80-90 questions that cover theoretical knowledge of PK/PD modeling, and a practical section that evaluates software proficiency by performing tests related to model building, evaluating model adequacy, comparing models, conducting simulations and customizing models using the Graphical Model Editor.  Time Limit:  The exam is divided into 2 parts. There is a time limit of 1hr 45min to complete part 1, and 1hr 15min to complete part 2 of the exam.  The clock starts counting when the user clicks on 'Start Exam' in each part. Exam Content:   Successful candidates should know both theory and practice of PK/PD modeling, from model building to simulation.  Certification topics include: Theory and Practice of PK/PD Modeling Determining Initial Estimates Residual Error Evaluate Model Adequacy and Compare Models Data Manipulation (Phoenix Data Tools) Customizing Models (Graphical Model Editor) Conducting Simulations Reporting Modeling Results Prerequisites and Time Commitment There are no mandatory pre-requisites for this course although familiarity with the Phoenix platform and NCA is highly recommended as well as a basic understanding of pharmacokinetics is preferred.  Courses that cover these topics are: (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course (103-OD) Fundamentals of Pharmacokinetics Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlinTM Participants are expected to have a current license to Phoenix WinNonlin.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license. Read more

Cost - $550 (Academia $275, Africa/India $150) Certification Course Description In this course you will learn the theory and application of compartmental PK modeling.  You will learn how to create Maximum Likelihood PK models using Phoenix WinNonlin software (version 8.3.x), and how to use those models to perform simulations.   You will use models to make decisions, such as evaluating different dosing regimens with respect to safety and efficacy.  In addition to using the built-in "library" models, you will learn to use the Graphical Model Editor to customize PK models.  The course includes lectures, practice exercises and quizzes. Course Format and Access  This course format is an 'On Demand' e-Learning course which means that the course is presented as a series of interactive modules that can be completed on your own schedule. You will have access to this course for 3 years.  No manual or printed material is associated with this course.  Note that Certara University also offers the content of this course as a live instructor-led course format (123-LO), which is considered a different course.  For times and availability for the live course, click here.   Pricing The price of this course is $550 (Academic $275, Africa/India $150) If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located on a permanent basis in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. If you are purchasing more than one course of have already taken the Live-Online version of this course, please contact us for additional discounts. Language and Course Length This course is delivered in English, with closed captions (which can be turned on/off as desired). The course has a total of approximately 2 hours of interactive content.  Learners should plan to spend at least 12 hours to complete the course. Prerequisites and Time Commitment Learners should be familiar with basic operations in Phoenix, including plotting and running NCA.  We recommend completing the course (122-OD-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course prior to taking this course. Software Phoenix WinNonlinTM Participants are required to have a current license of Phoenix.  The exercises can be completed without a license but it is recommended that students practice on their own. Read more

September-October 2024 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description The objective of this course is to train Phoenix WinNonlin users how to perform population PK using Phoenix NLME. Population PK/PD modeling is being used increasingly in regulatory submissions.  Population PK modeling can handle sparse data and also data combined from several studies.   The population approach estimates the variability between subjects in the PK parameters and can help you understand potential sources of PK variability. Through a series of practical exercises, learners will create population PK models, add covariates to models to help explain and quantify individual variation, and validate their models using bootstrap and VPC. Learners will become familiar with the theory necessary to make effective use of population modeling. Pricing Cost - $550 (Academia $275, Africa/India $150) If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you work on a permanent basis in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Course Format, Language and Dates This course format is as a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This format provides the benefit of the classroom setting, with real-time interaction with the instructor but without the travel.  Although live attending is encouraged, recordings of the sessions are available to participants during the length of the course. You will have access to the recordings for 3 months following the last session of the course. This course will be delivered in English. This course will be offered in September and October 2024.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 17 September and finishing on 22 October.  We will record sessions and post the recordings for those who are unable to attend live. There are also five weekly office hour sessions, in which gives a more extended period for asking and answering questions.  We have two options for people in different time zones:  Office Hour Option A is offered at times most convenient for participants in the Americas, Europe, and Africa.  They are on Fridays at 11 AM New York (GMT-4).  Office Hour Option B is offered at times most convenient for participants in Asia/Pacific.  They are on Tuesdays at 2 PM Brisbane (GMT+10).  (FYI, 2 PM Tuesday in Brisbane is late Monday evening in New York.) Practice Exercises There are five practice exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis.  Each practice exercise contains a quiz that you must pass with at least a 60% score, although you can repeat each quiz as many times as you need to pass it.  Certification Exam This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as a PK/PD Modeler using Phoenix WinNonlin version 8.4, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with Maximum Likelihood Models in Phoenix WinNonlin. Exam Details Software:  There is no requirement to have the Phoenix NLME™ software installed to take the exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix NLME 8.4. Grading: To successfully earn the Population Modeler certification, a minimum passing score of 75% must be achieved on both parts of the online accreditation exam. Each registration includes 2 attempts at passing each part of the test. The exam tests 80-90 questions that cover theoretical knowledge of population modeling, and a practical section that evaluates software proficiency with population models in Phoenix NLME. Time Limit:  The exam is divided into 2 parts. There is a time limit of 1hr 45min to complete part 1, and 1hr 15min to complete part 2 of the exam.  The clock starts counting when the user clicks on 'Start Exam' in each part. Exam Content:   Successful candidates should be able to use Phoenix NLME to create population models, including covariate analysis, covariance analysis, model validation, and simulation.  Exam topics include: Population PK Theory Data Preparation Exploratory Data Analysis Model Development Covariate Models Covariance Models Model Comparisons Model Validation (VPC and Bootstrap) Reporting Population Model Results Prerequisites and Time Commitment Fundamental knowledge of PK/PD concepts including basic compartmental models.  Familiarity with the functionality of Phoenix WinNonlin software.  Recommended background courses include: (103-OD) Fundamentals of Pharmacokinetics either (122-LIVE-CERT) or (122-OD-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course either (123-LIVE-CERT) or (123-OD-CERT) Phoenix WinNonlin (Part 2) PK/PD Modeling Certification Course Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlin and NLME Participants are expected to have current licenses for both Phoenix WinNonlin and Phoenix NLME.  If a 60-day software license is needed one can be provided for an additional fee.  Contact us if you want to order a license.   Read more

Cost - $1000 (Academia $500, Africa/India $250) Course Description This course focuses on PK/PD individual data analysis using PK compartmental models and PK/PD models. The intermediate PK/PD course will teach you how to set the models in Phoenix WinNonlin and how to interpret the results. The course will guide you through the process of selecting the best model and how to make predictions with the final model. Model selection is performed selecting library models, building the model graphically or coding the model in PML language. Course topics include nonlinear modelling theory, fitting PK data, effect compartment PK/PD models, direct and indirect response PK/PD models, analyzing binary data, designing better studies and combining data among subjects. A high level overview of population methods is provided (Note that population methods are covered in detail in courses that use Phoenix NLME). The concepts of each topic are explained in detail via instructional videos. Exercises are introduced and you are expected to practice concepts learned by performing the exercises on your own. Step by step solution videos are also provided to check your work. Your understanding of the concepts discussed is tested via short quizzes throughout the course. If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Software Used Phoenix WinNonlin™  A temporary (30-day) license is provided to subscribers of this course.  When you are ready to start the practice exercises in this course, contact us to request your license. Accessing the Course After registering for this course, login to www.certarauniversity.com and see the course under the Catalog Section ‘My Courses’.  You will have access to this course for a period of 3 years after the purchase. The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course. Course Length:  The course provides approximately 16 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites It is assumed that learners have familiarity with NCA and individual PK/PD modeling, a good background in pharmacokinetics and pharmacodynamics, and prior experience with the Phoenix is recommended. Participants should also be able to perform the tasks in the following Certara University courses: Introduction to Phoenix WinNonlin (Part 1) - NCA  (122-OD-CERT or 122-LIVE-CERT) Introduction to Phoenix WinNonlin (Part 2) - Modeling (123-OD-CERT or 123-LIVE-CERT) Instructor Ana Henry has extensive experience in a variety of roles in the Pharmaceutical industry. Most recently she acted as product manager for the complete suite of Certara Pharsight desktop products, personally leading the development of Phoenix®, the industry’s premier PK/PD software platform. Currently, she is with Certara University’s Scientific Training and Education Department, tasked with training and content development of on-demand courses. Ana has extensive experience in software demonstration and training and is adept at offering technical expertise and evaluation of software products. She has trained and provided support for Phoenix WinNonlin, Phoenix Connect, Phoenix NLME, Pharsight Knowledgebase Suite, AutoPilot, PKS Reporter, Trial Simulator, and PK/PD methodology courses. Prior to Certara, Ana worked in the pharmaceutical industry as a biostatistician and a pharmacokineticist, designing, analyzing and reporting on clinical studies. Ana is also a regular guest speaker in the graduate PK/PD course at the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. Read more

Cost - $1,000 (Academia $500, Africa/India $250) Course Description This course will help you fill the gaps to become a better Population Pharmacokinetic and Pharmacodynamic (PK/PD) modeler.  This e-learning course focuses on Population PK/PD modeling and simulation using the intuitive interface of Phoenix NLME.   This course topics include: population PK analysis with covariates, covariate search methods, complex PK models including multiple absorption processes and parent-metabolite models, Emax PK/PD models, an introduction to categorical response PD models, and modeling BLQ data in Phoenix NLME.  The concepts of each topic are explained in detail via instructional videos. Exercises are introduced and you are expected to practice concepts learned by performing the exercises on your own. Step by step solution videos are also provided to check your work. Your understanding of the concepts discussed is tested via short quizzes throughout the course. If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Software Used Phoenix NLME™ A temporary (30-day) license is provided to subscribers of this course.  When you are ready to start the practice exercises in this course, contact us to request your license. Accessing the Course After registering for this course, login to www.certarauniversity.com and you will see the course on your Dashboard.  You will have access to this course for a period of 3 years after the purchase. The purchase is for a single seat in the course. No sharing the login between different individuals is allowed. Additional seats must be purchased if more than one person wishes to take the training course. Course Length:  The course provides approximately 10 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites It is assumed that learners have familiarity with individual PK/PD modeling as well as introductory level population PK/PD modeling experience. Participants should have a good background in pharmacokinetics and pharmacodynamics, and prior experience with the Phoenix is recommended. Participants should also be able to perform the tasks in both the following Certara University courses: Intermediate PK/PD Modeling using Phoenix WinNonlin (On-Demand 200-OD) Introduction to Population PK/PD Modeling using Phoenix NLME (On-Demand 101-OD) Instructor Christopher Mehl Christopher Mehl is a Senior Software Trainer with Certara University, and has been with Certara since 2003. His educational background is a BS in Molecular Biology from the Ohio State University, and an MS in Pharmacology from the University of Wisconsin. He has conducted over 200 training courses with Certara products such as Phoenix WinNonlin, IVIVC, NLME, PKS, and Trial Simulator. These include workshops at the US Food and Drug Administration, universities, customer sites, and courses open to the public. Read more

Cost - $500 (Academia $250, Africa/India $125) Course Description This course is intended for Phoenix users who want to extend beyond library models, to model their own data.  It provides a solid foundation and a structured approach to model building, to create your own PK and PK/PD models.  This highly practical course gives an accelerated introduction to customizing models with both the Graphical and Textual model editors in Phoenix.  It assumes that you have ideas for PK and/or PK/PD models that you want to construct, and you mainly need to know how to implement them in either the Graphical or Textual modes.  The course includes a basic introduction to PK/PD modeling and population PK modeling. There are about 3 hours of video in the course, plus interactive exercises.  You should expect to spend about 12 hours of work to finish.  You will have access to this course for a period of 3 years after purchase. If you are an academic user, please contact us so we can update your account profile to give you access to academic pricing.  Note that you must register with an email address that is associated with an academic institution to get academic pricing. If you are located in Africa or India, please contact us so we can so we can update your account profile to give you access to the Africa/India pricing.  You will need to provide proof that you are physically located in India to get the pricing. Prerequisites Learners who take either the e-learning course (100-OD) Introduction to Phoenix WinNonlin or the live online course (123-LO) PK Modeling and Simulation using Phoenix WinNonlin should have sufficient background to take this course.  Alternatively, learners should have knowledge/skills in the following areas: Knowledge of basic concepts of PK models Using Phoenix PK Library models (i.e., using the built-in options) Obtaining initial estimates for PK models (using NCA or other methods) Evaluating the fit of PK models Other Related Courses The following courses provide a deeper theoretical background, and provide a good complement to this course: (200-OD) Intermediate PK/PD Modeling using Phoenix WinNonlin (201-OD) Intermediate Population Modeling using Phoenix NLME Read more