Certara Professional Courses and Certifications

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. 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 Software Used Phoenix WinNonlin and 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, access 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 6 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 24+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Fundamental knowledge of PK/PD concepts including basic compartmental models.  Familiarity with the functionality of Phoenix WinNonlin software.  Recommended background courses include: Phoenix WinNonlin (Part 1) NCA Certification Course Phoenix WinNonlin (Part 2) PK/PD Modeling Certification Course Instructor Nathan Teuscher is a leader in the pharmaceutical industry as a scientist, consultant, and teacher. Nathan has been teaching and training for over 15 years in the pharmaceutical industry, providing lectures in general pharmacokinetics to non-scientists, and specialized training in population pharmacokinetics and drug development to industry experts. Nathan also developed on-line training tools for Pharmacy students, intuitive software tools to aid in pharmacokinetic analysis, and a mobile application for calculation of pharmacokinetic parameters. His dynamic teaching style helps students understand the material and integrate the concepts into practice. 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