Certara Professional Courses and Certifications

Course Registration: $1,000 (Academic Discounts Available)  Bundle this course with the classroom (001-CL) Pharmacometrics Introductory 5-day Course for an additional discount (Purchase Bundle).  If you are an academic user, please contact us for available discounts. Course Description: Embark on a captivating journey into the realm of pharmacokinetics. This on-demand course will introduce you to the intricate science of pharmacokinetics and its practical applications in clinical settings, where understanding drug kinetics isn't just academic—it's the cornerstone of effective patient care. Developed as a conceptual course, this immersive learning experience, led by esteemed instructor Dr. Stephan Schmidt, UF-Certara Professor, offers a dynamic exploration of drug kinetics tailored to your learning pace and preferences. This course is designed to introduce you to drug kinetics and their practical applications in clinical practice. Throughout the course, participants will engage in hands-on exercises, case studies, quizzes, and simulations to reinforce theoretical concepts and enhance practical skills. By the end of the program, participants will gain proficiency in applying pharmacokinetic principles to optimize drug dosing regimens and improve therapeutic outcomes in clinical settings. You will benefit from Dr. Stephan Schmidt's expertise and guidance as he navigates you through complex pharmacokinetic principles and real-world applications.   Course Structure: Duration: Accessible for one year post-registration, providing ample time for comprehensive learning and review. Certificate of Completion: Earn a prestigious certificate by achieving a minimum grade of 80% on all quizzes, designed for unlimited attempts to ensure mastery. Sequential Learning: Modules are meticulously sequenced, guiding learners through a logical progression of topics for enhanced comprehension. Interactive Quizzes: Embedded quizzes offer opportunities for self-assessment, ensuring understanding before advancing to subsequent modules. Practical Assignments: Engage with hands-on assignments integrated within modules, complete with detailed instructions and downloadable solution links. No Downloadable Materials: To prioritize active engagement, recordings and lecture slides are unavailable for download, fostering focused learning. Software Used None Accessing the Course After registering for this course, login to https://www.certarauniversity.com/learner-dashboard to start the course  You will have access to this course for a period of 1 year 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, quizzes, and practice exercises  that you can do at your own pace. In addition,  It is expected to take participants about 40+ hours to complete. Prerequisites None Instructor Stephan Schmidt, B.Pharm., Ph.D., F.C.P.   Stephan Schmidt is an endowed Professor in the Department of Pharmaceutics at the University of Florida, where he also serves as the Director for the Center for Pharmacometrics and Systems Pharmacology. He received his B.S. in Pharmacy from the Friedrich-Alexander University in Erlangen, Germany, and his PhD in Pharmacy from the University of Florida in Gainesville, USA. Following a post-doctoral fellowship at the Leiden-Amsterdam Center for Drug Research, he rejoined the University of Florida as faculty in 2012. Dr. Schmidt’s research focuses on the development and application of mechanism/physiologically-based drug-disease trial models to address clinically relevant questions in the area of antimicrobial chemotherapy, chronic progressive diseases, special patient populations, and drug-drug interactions. He published more than 150 peer-reviewed scientific manuscripts, 8 book chapters, and 2 textbooks, including the fifth edition of Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics textbook, one of the world-wide leading textbooks in the quantitative clinical pharmacology arena. He received numerous awards including the University of Florida Excellence Award for Assistant Professors in 2013, the Tanabe Young Investigator Award from the American College of Clinical Pharmacology (ACCP) in 2016, the Outstanding Doctoral Thesis Mentoring Award from UF’s College of Pharmacy in 2018, the Excellence in Academia, MIDD+ Scientific Conference Award in 2021, and the University of Florida Research Foundation Professor Award in 2023. Dr. Schmidt serves as clinical pharmacology section editor of the European Journal of Pharmaceutical Sciences as well as editorial board member of the Journal of Clinical Pharmacology and the European Journal of Pharmaceutical Sciences, and Scientific Advisor to the Editors of the Journal of Pharmaceutical Sciences. Certificates: Participants who complete this course within 1 year will be provided with a Certificate of Completion from Certara University. Contact Us: For additional information, please contact us.  Read more

Cost - Free This complimentary course will teach you the new features, functionality and improvements available in Trial Simulator 2.3. Trial Simulation is used to optimize trial design to ensure greater success to meet trial objectives.  This course is intended  for users who have prior experience with Trial Simulator and who are upgrading to version 2.3.  Although certain sections might  help new users to better understand the aspects of trial simulation prior experience is recommended.  The course explains the new features that have been added and also contains a practical component to verify knowledge. There is no need to have the software installed locally to take this short course and do the practical sections. Course Content Introduction Installation, configuration, supported OS, other 3rd party compatibility Accessing study files and simulation results from previous version PK/PD Trial Simulation Demonstration [includes an interactive section] Plotting and Analysis using R Software within Trial Simulator [includes an interactive section] Conclusions Software Used Trial Simulator 2.3 (No need to install locally) Course Length:  The course provides approximately 2 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 4 hours to complete, including time to perform the tasks in Trial Simulator 2.3. Prerequisites Participants should have a good background in pharmacokinetics and pharmacodynamics modeling and simulation, and ideally, prior experience with Trial Simulator software. Instructor 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

August-September 2026 Cost - $550 (Academia $275, Africa/India $150) Certification Course Overview Gain certification in non-compartmental analysis (NCA) using Phoenix WinNonlin. This course covers theory, application, and hands-on practice, culminating in a certification exam. Upon successful completion, participants receive an e-badge valid for 3 years. Course Structure Total Duration: 18 hours of live sessions + 5 self-paced exercises Live Components: - 6 × 2-hour lecture/demo sessions - 6 × 1-hour hands-on group exercises Access: Recordings available for 3 months post-course Prerequisites Knowledge of PK concepts. Suggested prep course:  103-OD Fundamentals of Pharmacokinetics Live Sessions - Lecture/Demo: Tuesdays, 10AM–12PM (Aug 11 - Sep 15) - Hands-on Exercises: Fridays, 11AM–12PM (Aug 14 - Sep 18) Who Should Attend - Professionals working in pharmacokinetics - Researchers and analysts using Phoenix WinNonlin - Individuals with basic PK knowledge Certification Exam Software: No installation required; interactive simulation based on Phoenix WinNonlin 8.4/8.5 Structure: Two parts - Part 1: 1 hr 45 min - Part 2: 75 min Content: 80–90 questions covering theory and practical application Passing Score: 75% on both parts Attempts: Two included Topics: Basic PK and NCA theory, Phoenix interface, exploratory data analysis (data tools and plots), performing NCA in Phoenix, processing NCA results, nonparametric superpositioning, study designs. Time Commitment Estimated 5 hours/week for live sessions and assignments, plus up to 6 hours for the certification exam Software Requirements Phoenix WinNonlinTM license required Training License: Available for purchase (Request Info: info@certarauniversity.com) Pricing $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Session Topics Week 1 main session: course overview, intro to NCA, phoenix overview, exploratory data analysis. Week 1 hands-on session: exploratory data analysis, plots. Week 2 main session: concentrations, observed NCA parameters, study design effects, data tools. Week 2 hands-on session:  use data tools, create tables. Week 3 main session: half-life, AUC, best fit algorithm, handling BQL data. Week 3 hands-on session: make BQL substitutions, run NCA, customize slope selections, evaluate NCA results. Week 4 main session: Cmax/AUC decisions, bioavailability, study designs, dose proportionality, average bioequivalence. Week 4 hands-on session: run bioequivalence for a 2x2 study, evaluate dose proportionality. Bonus video: food effects, drug-drug interactions, RSABE. Week 5 main session: NCA with steady state, sparse, and urine data, object templates, experimental design, nonparametric superpositioning. Week 5 hands-on session: run NCA on sparse data, run NCA on steady-state data. Week 6 main session:  data presentation, exporting, tables, reporting, workflow templates. Week 6 hands-on session: workflow templates. Read more

January-March 2026 Cost - $550 (Academia $275, Africa/India $150) Certification Course Overview Gain certification in non-compartmental analysis (NCA) using Phoenix WinNonlin. This course covers theory, application, and hands-on practice, culminating in a certification exam. Upon successful completion, participants receive an e-badge valid for 3 years. Course Structure Total Duration: 18 hours of live sessions + 5 self-paced exercises Live Components: - 6 × 2-hour lecture/demo sessions - 6 × 1-hour hands-on group exercises Access: Recordings available for 3 months post-course Prerequisites Knowledge of PK concepts. Suggested prep course:  103-OD Fundamentals of Pharmacokinetics Live Sessions - Lecture/Demo: Tuesdays, 10AM–12PM (Jan 27 – Mar 3) - Hands-on Exercises: Fridays, 11AM–12PM (Jan 30 – Mar 6) Who Should Attend - Professionals working in pharmacokinetics - Researchers and analysts using Phoenix WinNonlin - Individuals with basic PK knowledge Certification Exam Software: No installation required; interactive simulation based on Phoenix WinNonlin 8.4/8.5 Structure: Two parts - Part 1: 1 hr 45 min - Part 2: 75 min Content: 80–90 questions covering theory and practical application Passing Score: 75% on both parts Attempts: Two included Topics: Basic PK and NCA theory, Phoenix interface, exploratory data analysis (data tools and plots), performing NCA in Phoenix, processing NCA results, nonparametric superpositioning, study designs. Time Commitment Estimated 5 hours/week for live sessions and assignments, plus up to 6 hours for the certification exam Software Requirements Phoenix WinNonlinTM license required Training License: Available for purchase (Request Info: info@certarauniversity.com) Pricing $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Session Topics Week 1 main session: course overview, intro to NCA, phoenix overview, exploratory data analysis. Week 1 hands-on session: exploratory data analysis, plots. Week 2 main session: concentrations, observed NCA parameters, study design effects, data tools. Week 2 hands-on session:  use data tools, create tables. Week 3 main session: half-life, AUC, best fit algorithm, handling BQL data. Week 3 hands-on session: make BQL substitutions, run NCA, customize slope selections, evaluate NCA results. Week 4 main session: Cmax/AUC decisions, bioavailability, study designs, dose proportionality, average bioequivalence. Week 4 hands-on session: run bioequivalence for a 2x2 study, evaluate dose proportionality. Bonus video: food effects, drug-drug interactions, RSABE. Week 5 main session: NCA with steady state, sparse, and urine data, object templates, experimental design, nonparametric superpositioning. Week 5 hands-on session: run NCA on sparse data, run NCA on steady-state data. Week 6 main session:  data presentation, exporting, tables, reporting, workflow templates. Week 6 hands-on session: workflow templates. Read more

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) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. 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.  Each module contains a quiz that you must pass to complete the course.  You must achieve at least 60% on each quiz to pass it, although you can take as many attempts as necessary to do so. 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 (122-LIVE) . This is considered a different course.  For times and availability for the live course, click here.   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 6 hours of interactive content.  Learners should plan to spend at least 18 hours to complete the course, plus 3 hours for the certification exam. Prerequisites and Time Commitment There are no pre-requisites for this course although basic understanding of pharmacokinetics is preferred (recommended background: (103-OD) Fundamentals of Pharmacokinetics).  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 either version 8.4 or 8.5, 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 or 8.5. 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 to take the certification exam.  The exam has interactive questions embedded that simulate the software.  Those interactive questions are based on Phoenix WinNonlin 8.4 or 8.5. 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 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

March-April 2026 Cost - $550 (Academia $275, Africa/India $150) Certification Course Overview This certification course focuses on compartmental PK/PD modeling using Phoenix WinNonlin. Participants will learn to build and customize Maximum Likelihood models, evaluate model adequacy, and use simulations to inform dosing decisions. The course emphasizes hands-on experience with Phoenix’s Graphical Model Editor and includes both theoretical and practical components. Course Structure Total Duration: 18 hours of live sessions + 5 self-paced exercises Live Components: - 6 × 2-hour lecture/demo sessions - 6 × 1-hour hands-on group exercises Access: Recordings available for 3 months post-course Prerequisites Familiarity with Phoenix and basic PK concepts is recommended. Suggested prep courses: (122-LIVE-CERT) Phoenix WinNonlin (Part 1) NCA Certification Course (103-OD) Fundamentals of Pharmacokinetics 2026 Live Sessions - Lecture/Demo: Tuesdays, March 10 – April 14 (10AM–12PM ET) - Hands-on Exercises: Fridays, March 13 – April 17 (11AM–12PM ET) Who Should Attend This course is ideal for: - Scientists and analysts working in pharmacokinetics, pharmacodynamics, or pharmacometrics - Clinical pharmacologists seeking to learn PK/PD modeling skills - Professionals using Phoenix WinNonlin for drug development or regulatory submissions - Academic researchers and graduate students who work with drug development - Anyone who has completed the NCA certification course and wants to develop skills in modeling and simulation Certification Exam Software: No installation required; interactive simulation based on Phoenix WinNonlin 8.4/8.5 Structure: Two parts - Part 1: 1 hr 45 min - Part 2: 75 min Content: 80–90 questions covering theory and practical application Passing Score: 75% on both parts Attempts: Two included Topics: PK/PD theory, model building, simulations, error models, graphical/textual model editing Time Commitment Estimated 5 hours/week for live sessions and assignments, plus up to 6 hours for the certification exam Software Requirements Phoenix WinNonlinTM license required 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. Pricing Cost - $550 (Academia $275, Africa/India $150) Users requesting an Academic membership will only be accepted with proof of academic status by using an active academic email address. Users from Africa/India will need to provide Certara University with a copy of their government issued proof of residency.  If an email address fails to meet that standard, the individual will be notified and will not be given access to the requested membership type. Session Topics Week 1 main session:  Course overview, motivation for modeling and simulation, introduction to PK modeling, exploratory data analysis, introduction to the Maximum Likelihood Model object. Week 1 hands-on exercise session:  Examine results of IV-bolus model (previously executed), examine results of PO model (previously executed). Week 2 main session: Review of PK modeling, structural models (administration, time lag, number of compartments, etc.), secondary parameters, data structure for compartmental modeling Week 2 hands-on exercise session:  Create 1-compartment IV-bolus model, create 2-compartment IV-bolus model, decide which model better fits the data. Week 3 main session:  How to obtain initial estimates, residual error models, interpretation of model results. Week 3 hands-on exercise session: Create 1- and 2-compartment models for the PO data, compare models and decide which better fits the data, determine the best residual error model for the data. Week 4 main session: simple simulations, comparing models, how to report individual modeling results. Week 4 hands-on exercise session:  Create a basic simulation, create a simulation using ADDL, develop a safe and efficacious dosing regimen. Week 5 main session: Simulations (NPS, ADDL and SS), graphical model editor (including a simple TMDD). Week 5 hands-on exercise session:  Use graphical editor to create IV/PO model, determine bioavailability. Week 6 main session:  Advanced topics (modeling metabolites, selection of time points, troubleshooting, text mode), demo of PD, discuss population modeling, quick demo of naive pooled population model, closing remarks. Week 6 hands-on exercise session:  Use graphical model editor, use textual model editor. Read more