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) 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. 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

Cost - $500 (Academia $250, Africa/India $125) Course Description This training will utilize hands-on examples to instruct attendees in the use of the IVIVC Toolkit for Phoenix WinNonlin, which expands the capabilities of Phoenix WinNonlin to include in vivo-in vitro correlations (IVIVC) analysis. The Toolkit contains advanced tools for deconvolution methods, numerical convolution, new plotting capability, and the IVIVC Wizard. 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 IVIVC™ 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 4.5 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 18+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Basic knowledge of Phoenix WinNonlin is recommended, particularly in conducting NCA analyses. It is also useful for learners to have some PK modeling experience. We recommend that participants know how to perform the tasks in the following Certara University course: Phoenix WinNonlin (Part 1) NCA Certification Course | e-Learning (122-OD-CERT)  Instructor Simon Davis has been supporting and training scientists in the pharmaceutical industry to configure and use PKPD modelling tools effectively. Initially working in Covance’s Phase I clinic analysing BE, FIM studies etc. using WinNonlin & SAS, he spent several years providing Support and Training for Watson, EP and Kinetica software whilst at InnaPhase, (now ThermoFisher). Since 2005 he has focused on the Phoenix platform modules of WinNonlin, IVIVC, Connect, PKS & NLME. As well as providing hands on training to users he also gives development direction to ensure this suite of tools meet the needs of our diverse users; from simple NCA and IVIVC under GxP, to advanced modelers and connect with other industry databases and analytical tools e.g. R & NONMEM. Read more

Cost - $299 (Academia $150, Africa/India $75) - [Conceptual Course] Course Description This course teaches the basic principles of pharmacokinetics including absorption, distribution, metabolism, and excretion. The lessons are taught by a vibrant instructor who uses real-world examples to explain the key concepts.  This course will provide the student confidence to discuss basic pharmacokinetic concepts. 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 None 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 1.5 hours of video instruction and quizzes that you can do at your own pace. It is expected to take participants about 3+ hours to complete. Prerequisites None Instructor Ana Henry 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.span> Read more

Cost - $299 (Academia $150, Africa/India $75) - [Conceptual Course] Course Description This course is a comprehensive overview of noncompartmental analysis of pharmacokinetic data. This course will cover the basics through the most complex areas of noncompartmental analysis. The course includes video presentations, spreadsheet-based problems, and guided answers. Anyone with interest in pharmacokinetics, drug disposition, drug metabolism should take this course. In addition, this course is an excellent primer for pharmacists, physicians, and other healthcare professions that work with pharmaceutical agents. In addition, clinical trial managers and clinical research associates would benefit from this 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 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. Software Used Using a spreadsheet (such as Microsoft Excel™) is recommended for doing the calculations. This course teaches NCA concepts and doesn't include the use of Phoenix WinNonlin.  To learn how to use Phoenix WinNonlin to do NCA, see courses (122-LO) or (100-OD). Accessing the Course After registering for this course, login to certarauniversity.com and 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 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 a spreadsheet program. Prerequisites None Instructor Tom Jones Tom Jones has helped thousands of scientists become proficient with using Certara software in their research in the pharmaceutical industry. After completing his Ph.D. in analytical chemistry, he spent several years as an assistant professor, during which time he applied molecular modeling to teaching and research in chemistry, and then came to Certara, where for 18 years he has applied his passion for teaching scientific software applications. At first Tom was focused exclusively on molecular modeling applications in drug discovery and later broadened his expertise to include informatics and PK/PD modeling and analysis. He has created many training manuals, and you may very well have heard his voice in one of the numerous webinars and video demos he has created to help scientists become more proficient with Certara software. Read more

Course Registration: $1,500 (Academic Discounts Available)  Bundle this course with the (001-CL) Pharmacometrics Introductory 5-day Course (Orlando September 23-27, 2024) classroom 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 - $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 Exam 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.   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 8.4. 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 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