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

Complimentary Phoenix Templates for Bioequivalence. Several easy-to-use Phoenix templates, that require minimum user input, have been developed to address a series of BE regulatory guidances.  In this course, we discuss the purpose of each Phoenix workflow template,  show you how to download templates, and teach you and how to use them. Course Content: Module 1: Template Downloads Module 2: Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA Module 3: Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA Module 4: Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA Module 5: Assessing ABE and PBE for In Vitro Data of Inhaled Products (Guidance on Budesonide) - FDA Read more

Cost - Free PML-School: Learn How to Build Custom PK and PK/PD Models in Phoenix WinNonlin In this series of videos you will learn how to create models using Phoenix Modeling Language (PML).  These are the recordings of the PML school webinars which can also be found on the Phoenix Support Forum. Read more