Certara Professional Courses and Certifications

June-July 2024 Cost - $550 (Academia $275, Africa/India $150) Certification Course Description In this course you will learn and get certified on the theory and application of non-compartmental analysis (NCA).  NCA is used to characterize the kinetics of a compound without assuming a specific compartmental model.   You will learn NCA methodology, how to perform NCA using Phoenix WinNonlin software, and how to interpret resulting pharmacokinetic parameters.   This course is a comprehensive review of noncompartmental analysis of pharmacokinetic data and will cover the basics through the most complex areas of noncompartmental analysis.  Upon successful completion of this course, you will receive an e-badge as an NCA Analyst using Phoenix WinNonlin.  This certification is valid for 3 years. Pricing $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 a ‘Live on-line classroom’ which means that the course is delivered virtually by an expert Phoenix instructor at pre-specified times.  This will provide 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 June and July, 2024.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting June 4 and finishing on July 9.  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.)  We will offer the "Option B" office hours if there is sufficient interest among the students. 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 This course includes a certification exam.  To obtain credit for this course and earn a Certara Certification as an NCA Analyst using Phoenix WinNonlin version 8.4, candidates need to earn a passing score on the exam.  The exam validates proficiency and competence with non-compartmental (NCA) pharmacokinetic (PK) analysis using Phoenix WinNonlin, with version 8.4. A certified NCA analyst can process data, perform exploratory data analysis, calculate NCA parameters, and report results for typical PK study designs in pre-clinical and clinical trials.   Exam Details Software:  There is no requirement to have the Phoenix WinNonlin™ software installed.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix WinNonlin 8.4. Grading: To successfully earn the NCA Analyst 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 the test. The exam tests 80-90 questions that cover theoretical knowledge of NCA analysis on different types of study designs, and a practical section that evaluates software proficiency by performing tests related to NCA analysis, data processing, and reporting.  Time Limit:  The exam is divided into 2 parts. There is a total time limit of 1 hr and 45 min to complete part 1 and 75 minutes 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 understand fundamentals of Pharmacokinetics, NCA theory, typical study designs that are often analyzed with NCA, and hands-on experience with Phoenix WinNonlin.  Certification topics include: Basic Theory of PK and NCA Phoenix Interface Exploratory Data Analysis - Data Tools and Plots Performing NCA in Phoenix Processing NCA results Non-Parametric Superposition Study Designs Prerequisites and Time Commitment This course requires basic understanding of pharmacokinetics (recommended background: (103-OD) Fundamentals of Pharmacokinetics).  Students are expected to be able to commit 5 hours a week to attend sessions and complete assignments. Software Phoenix WinNonlinTM Participants are required to have a current license of Phoenix.  A training license for the duration of the course can be purchased for an additional fee by contacting us. Read more

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

April-May 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.  Upon successful completion of this course, you will receive an e-badge as a Population Modeler using Phoenix NLME.  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 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 April and May 2024.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 23 April and finishing on 28 May.  We will record sessions and post the recordings for those who are unable to attend live. Self-Paced Exercises There are five self-paced exercises in the course that guide you through exploratory data analysis, data preparation, and noncompartmental data analysis.  You do not need to run Phoenix to do the self-paced exercises, because everything is contained in the module.  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.  Hands-on Exercise Sessions There are also five weekly "Hands-on Exercise" Zoom sessions that give you the opportunity to carry out the same analysis as in that week's "Self-Paced Exercise", working collectively in Phoenix.  You will be divided into small groups, and will work together on the exercise.  At least one in each group will need to have Phoenix running on their computer and have an active NLME license. Hands On Exercise Session 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).  Hands On Exercise Session 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.) Certification Exam This course includes a certification exam.  To obtain credit for this course and earn a Certara Certified Population PK/PD Pharmacometrician (Level 1) using Phoenix NLME 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

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

November - December 2024 Cost - $500 (Academia $250, India $125) Course Description The objective of this intermediate course is to consolidate knowledge of PK/PD concepts and advance to performing more complicated PK/PD modeling using Phoenix WinNonlin and Phoenix NLME.  You will learn how to customize your own models beyond library models, how to interpret and present your results, perform simulations, and how to deal with different types of covariates such as occasion covariates, and much more.  This course will also cover pharmacodynamic concepts and examples. Many case studies will be presented (please see agenda below).  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 India, please contact us so we can provide a coupon that will give 75% off the full price of the course.  You will need to provide proof that you are physically located in India to get the coupon. 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 November and December 2024.  There will be six two-hour lecture/demo sessions.  Lecture/Demo sessions are on Tuesdays at 10 AM New York (GMT-4), starting 5 November and finishing 17 December.  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.) Prerequisites and Time Commitment Good knowledge of PK/PD concepts including compartmental models for both individual and population.  Experience with the functionality of Phoenix WinNonlin and Phoenix NLME software.  Prerequisite background courses or similar experience include:  [(123-LO) PK Modeling and Simulation and (124-LO) Introduction to Population Modeling] or [(100-OD) Introduction to Phoenix WinNonlin and (101-OD) Introduction to Population Modeling] Students are expected to be able to commit 5 hrs a week to attend sessions and complete assignments. Software Phoenix WinNonlin and Phoenix NLME Participants are expected to have a current license to 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. Certara Professional Certification [Optional] Participants may opt to pay a fee ($50) to obtain an additional professional certification as a Level 1 Pharmacometrician.  This certification requires passing an exam that this course will give you the sufficient knowledge to pass.  Contact us to add this certification to this course registration.  Click here for more details on Certara Professional Certifications. Read more

Bundle Cost - $900 ($450 Academia, $225 Africa/India) This bundle is recommended for scientists who want to earn the Certara NCA certification and who are new to pharmacokinetics. Those who successfully complete the certification course will earn the following certification: Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.3 This bundle includes three courses: two conceptual courses (delivered in e-learning format) and one certification course (delivered live online). The certification exams are included in the certification courses.  If purchased separately, the three courses would cost $1148, so you can save $248 by purchasing the bundle. Courses Included (see Content Tab for details) (103-OD) Fundamentals of Pharmacokinetics [Conceptual Course] | e-learning format (105-OD) Noncompartmental Data Analysis [Conceptual Course] | e-learning format (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course | live online format Read more