Certara Professional Courses and Certifications

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Cost - $1,800 (Academia $900) This course aims to give the course participants confidence and encouragement to learn advanced topics in PK/PD data analysis, and to practice on real life case studies from discovery, preclinical and development. Lectures cover many topics including nonlinear absorption, nonlinear disposition, binary PD outcomes, experimental design, target mediated drug disposition, instantaneous and delayed drug responses, effect-compartment, turnover and binding models, modeling tolerance and rebound, transduction, and an introduction to population PK. 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. Software Used Phoenix WinNonlin™ and Phoenix 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, login to www.certarauniversity.com and you will see the course on 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 10 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 40+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Participants need to have a good understanding of Phoenix WinNonlin and PML coding (for custom models). Participants should also be able to perform the tasks in the following Certara University courses: Intermediate PK/PD Modeling Using Phoenix WinNonlin (On-Demand 200-OD or Classroom 200-CL) 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. Dan Weiner Dan Weiner has extensive drug development experience and has served as an expert consultant to the U.S. Food and Drug Administration (FDA) on pharmacokinetic modeling and bioequivalence assessment. Prior to his previous tenure with Certara/Pharsight as a Senior Vice President and Chief Science Officer, Dr. Weiner held several management positions with Merrell Dow Pharmaceuticals; Statistical Consultants, Inc.; Syntex Development Research; Quintiles; and IVAX Research. Dr. Weiner graduated from the University of Kentucky with a doctoral degree in Mathematical Statistics, with emphasis on compartmental modeling. He is the original designer/author of the WinNonlin family of PK/PD Modeling Software now used by over 1,000 institutions. He is the co-author of Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, now in its 5th ed. Dr. Weiner is an Adjunct Associate Professor with Division of Pharmacotherapy and Experimental Therapeutics in the School of Pharmacy, University of North Carolina and is an Affiliate Professor of Pharmacometrics, Center for Translational Medicine in the School of Pharmacy at the University of Maryland. During his career he has provided PK/PD training to over 2,000 students.  He is currently a consultant in model-based drug development. Read More

Cost - $1,000 (Academia $500) This course is designed to explore advanced techniques in pharmacokinetic and pharmacodynamics modelling and simulation that are directly applicable to current challenges in drug development. In depth theory is coupled with examples from current literature to provide a complete training experience. Topics include complicated population pharmacokinetic models, PK/PD modelling of oncology studies, modelling transit compartments, target mediated drug disposition, and extrapolation from adults to children. 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. Software Used Phoenix 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, login to www.certarauniversity.com and you will see the course on 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 3 hours of video instruction which includes a practical component that you can do at your own pace. It is expected to take participants about 12+ hours to complete, including time to perform the tasks in Phoenix. Prerequisites Before attending this course, attendees should be familiar with creating models using PML (Phoenix Modeling Language). Participants should also be able to perform the tasks in the following Certara University courses: Introduction to Population Modeling using Phoenix NLME (On-Demand 101-OD or Classroom 101-CL) Intermediate Population Modeling using Phoenix NLME (On-Demand 201-OD or Classroom 201-CL) Instructor Carlos Rodríguez, Ph.D. Director, Clinical Pharmacology and PK/PD, PharmaPolaris International, Inc. Carlos Rodríguez has over 25 years of experience in the pharmaceutical industry in the areas of Clinical and Preclinical Pharmacokinetics, Drug Metabolism, Clinical Pharmacology, and Pharmacometrics. Dr. Rodríguez obtained a B.S. in Pharmacy from the University of Puerto Rico in 1986, and Ph.D. in Pharmaceutics from The University of Michigan in 1991. He joined The Upjohn Company in 1991 as a Scientist supporting preclinical pharmacokinetics and bioanalysis in the areas of CNS, metabolic diseases, cardiovascular, and anti-infectives. In 1997 he joined the clinical pharmacology unit (then Pharmacia & Upjohn), where he supported development projects in CNS and infectious diseases. In 2001, he became Associate Director of Pharmacokinetics at Chiron Corporation, where he supported small and large molecule programs in anti-infectives, oncology, and organ transplantation. In 2005, he became Director of Clinical Pharmacology at Roche Palo Alto, where he had direct responsibility over the clinical pharmacology development aspects of compounds in the anti-infective and inflammation therapeutic areas, including small and large molecules. He joined PharmaPolaris in 2007. Dr. Rodríguez has been involved in numerous IND submissions and participated in at least 10 NDA filings. In addition to Clinical Pharmacology, his research interests include Renal Drug Transport, Pharmacostatistical Modeling, Clinical Trial Simulation, and Population PK/PD. Dr. Rodríguez serves in the faculty of The University of Michigan, where he is Adjunct Associate Professor of Pharmaceutical Sciences, and in the faculty of the University of the Pacific, where he is Adjunct Professor of Pharmaceutics and Medicinal Chemistry. He lectures at the undergraduate and graduate levels in the areas of Pharmacokinetics, Physical Pharmacy, and Pharmacometrics. Read More

Certification Exam Cost ($299) To earn a Certara Certification as a NCA Analyst using Phoenix WinNonlin version 8.0, candidates need to earn a passing score in the exam.  The exam validates proficiency and competence with non-compartmental (NCA) pharmacokinetic (PK) analysis using Phoenix WinNonlin version 8.0. A certified NCA analyst has the ability to process data, perform exploratory data analysis, calculate NCA parameters, and report results for typical PK study designs in pre-clinical and clinical trials. Location:  This is an online accreditation. The exam can be taken from anywhere at any time within 3 years of purchase. Software:  There is no requirement to have the Phoenix WinNonlin software installed.  The exam has interactive questions imbedded that simulate the software. Grading: To successfully earn the NCA Analyst certification, a minimum passing score of 75% must be achieved upon completion of a rigorous 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:  There is a time limit of 3 minutes to answer each question with a maximum allocated time of 3 hours to complete the exam.  The clock starts counting when the user clicks on 'Start Exam'. Exam Content:   Successful candidates should have an understanding of fundamentals of Pharmacokinetics, NCA theory, typical study designs that are often analyzed with NCA,  and hands-on experience with Phoenix WinNonlin.  Certification topics include: Exam Content Basic Theory of PK and NCA Phoenix Interphase Exploratory Data Analysis - Data Tools and Plots Performing NCA in Phoenix Non-Parametric Superposition Study Designs Click on the image above to expand the 'Exam Content' file for a description of each section of the exam and its contribution to the total score.   Accreditation:  This certification is valid for 3 years.  Upon successful completion of the Certara professional certification exam recipients will be issued a digital badge by ACCLAIM. This is a secure, verifiable and standardized delivery method of achievement, and includes all the information about the certification that has been earned, including a detailed description of the exam.  Recipients can opt to make the badge private or public and the earned certification can be listed in a publicly searchable directory.  The eBadges, valid for three years, can be easily embedded on résumés, emails, web sites, and social and professional networking web sites, including and LinkedIn and Facebook.  In addition, a printed certificate of your achievement that includes a verification link can be requested. Pre-Requisites:  There are no pre-requisites required to take the Certara Certified NCA Analyst certification accreditation, several Certara University courses, or equivalent experience, can help to prepare for the certification: Fundamentals of Pharmacokinetics (103-OD), Noncompartmental Data Analysis (105-OD), and either the E-learning (100-OD) or Classroom (100-CL)  Introduction to Phoenix WinNonlin.  If you are not familiar with Phoenix WinNonlin version 8.0 but you know earlier versions, it is recommended that you watch the free webinars on 'What is New' in each version  (Check the 'PK/PD Free content' Catalog) or take a course at Certara University.  Read More

Certification Exam Cost ($299) To earn a Certara Certification as a NCA Analyst using Phoenix WinNonlin versions 8.1 and 8.2, candidates need to earn a passing score in the exam.  The exam validates proficiency and competence with non-compartmental (NCA) pharmacokinetic (PK) analysis using Phoenix WinNonlin, with either version 8.1 or 8.2. A certified NCA analyst has the ability to process data, perform exploratory data analysis, calculate NCA parameters, and report results for typical PK study designs in pre-clinical and clinical trials. This exam is applicable to two versions of Phoenix, because no new features that affect NCA were introduced in version 8.2. Location:  This is an online accreditation. The exam can be taken from anywhere at any time within 3 years of purchase. Software:  There is no requirement to have the Phoenix WinNonlin™ software installed.  The exam has interactive questions embedded that simulate the software.  Because Phoenix 8.1 and 8.2 have very few differences, this exam covers both versions. Grading: To successfully earn the NCA Analyst certification, a minimum passing score of 75% must be achieved upon completion of a rigorous 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:  There is a time limit of 3 hours to complete the exam.  The clock starts counting when the user clicks on 'Start Exam'. Exam Content:   Successful candidates should have an understanding of fundamentals of Pharmacokinetics, NCA theory, typical study designs that are often analyzed with NCA,  and hands-on experience with Phoenix WinNonlin.  Certification topics include: Exam Content Basic Theory of PK and NCA Phoenix Interphase Exploratory Data Analysis - Data Tools and Plots Performing NCA in Phoenix Processing NCA results Non-Parametric Superposition Study Designs Click on the image above to expand the 'Exam Content' file for a description of each section of the exam and its contribution to the total score.   Accreditation:  This certification is valid for 3 years.  Upon successful completion of the Certara professional certification exam recipients will be issued a digital badge by ACCLAIM. This is a secure, verifiable and standardized delivery method of achievement, and includes all the information about the certification that has been earned, including a detailed description of the exam.  Recipients can opt to make the badge private or public and the earned certification can be listed in a publicly searchable directory.  The eBadges, valid for three years, can be easily embedded on résumés, emails, web sites, and social and professional networking web sites, including and LinkedIn and Facebook.  In addition, a printed certificate of your achievement that includes a verification link can be requested. Pre-Requisites:  There are no pre-requisites required to take the Certara Certified NCA Analyst certification accreditation, several Certara University courses, or equivalent experience, can help to prepare for the certification: Fundamentals of Pharmacokinetics (103-OD), Noncompartmental Data Analysis (105-OD), and either the E-learning (100-OD) or Classroom (100-CL) Introduction to Phoenix WinNonlin.  If you are not familiar with version 8.1 or 8.2 of Phoenix WinNonlin, but you know earlier versions, it is recommended that you register for one or more of the free 'What is New' courses (you will find them in the Catalog, which is visible after logging in).  Read More

Certification Exam Cost ($299) To earn a certification as a Population PK/PD Pharmacometrician (Level 1) using Phoenix NLME using versions 8.0, 8.1 or 8.2, one needs to pass a rigorous exam to demonstrate competence in the analysis of continuous responses using Population PK/PD methodology. This exam includes an assessment on the use of  Phoenix NLME.  A Level 1 Pharmacometrician has the ability to prepare Pop. PK/PD data, perform Exploratory Data Analysis, determine initial estimates, build and evaluate Population PK/PD models including covariates, and report results for typical population PK/PD studies. This exam is applicable to three versions of Phoenix, because no new features that affect NLME were introduced in versions 8.1 or 8.2. Location:  This is an online accreditation.  The exam can be taken from anywhere at any time within 3 years of purchase. Software:   There is no requirement to have the Phoenix NLME™ software installed.  The exam has interactive questions embedded that simulate the software.  There are few significant differences in NLME between Phoenix versions 8.0, 8.1 and 8.2, and this exam is applicable to all three versions. Grading:  To become certified as a Population PK/PD, Level 1, pharmacometrician, a minimum passing score of 75% must be achieved upon completion of a rigorous online accreditation exam. Each registration includes 2 attempts at passing the test. The exam consists of about 75 covering theoretical knowledge of population PK/PD methodology and a second part consisting of interactive tests of software proficiency by performing tasks related to population PK/PD analysis, data preparation, EDA, building and assessing models, reporting, and simulation for typical population PK/PD studies. Time Limit:   There is no set time limit to answer each question, but there is a maximum allocated time of 3 hours to complete the exam (Part 1 has a time limit of 105 minutes, and Part 2 has a time limit of 75 minutes).   The clock starts counting when the user clicks on 'Start Exam'.  Each part of the exam is timed independently, and can be taken at different times. You can take the exam any time within three years of purchase. Exam Content:    Successful candidates should have an understanding of fundamentals of Population PK/PD related to continuous responses.  Certification topics include: Exam Content:  Fundamental Theory of Population Approach (20%) Data Evaluation & preparation (13 %) Exploratory analyses and initial estimates (9%) Model development (27%) Model evaluation (11%) Bootstrap and VPC Simulations (7%) Reporting and communicating results (13%) Click on the image to open the 'Exam Content' file for a description of each section of the exam and its contribution to the total score.  Accreditation:  This certification is valid for 3 years.  Upon successful completion of the Certara professional certification exam recipients will be issued a digital badge by ACCLAIM. This is a secure, verifiable and standardized delivery method of achievement, and includes all the information about the certification that has been earned, including a detailed description of the exam.  Recipients can opt to make the badge private or public and the earned certification can be listed in a publicly searchable directory.  The eBadges, valid for three years, can be easily embedded on résumés, emails, web sites, and social and professional networking web sites, including and LinkedIn and Facebook.  In addition, a printable certificate of your achievement that includes a verification link can be requested. Prerequisites:  Although there are no pre-requisites required to take the Certification as a Population PK/PD Level 1 Pharmacometrician accreditation, the following Certara University course can help to prepare for the certification: Introduction to Population PK/PD using Phoenix NLME On-Demand (101-OD), or Classroom (101-CL) Read More

Certification Exam Cost ($49)  This is the update test for people who have previously completed the certification:  Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.0 This will provide you a second certification: Certara Certified NCA Analyst using Phoenix WinNonlin Version 8.1/8.2 This exam is applicable to two versions of Phoenix, because no new features that affect NCA were introduced in version 8.2. Prerequisites:  Only candidates who hold a certification as Certara Certified NCA Analyst using Phoenix version 8.0 can take this update test. Location:  This is an online accreditation. The exam can be taken from anywhere at any time within 3 years of purchase. Software:  There is no requirement to have the Phoenix WinNonlin™ software installed.  The exam has interactive questions embedded that simulate the software.  There are few significant differences in NCA between Phoenix WinNonlin™ 8.1 and 8.2, and this exam covers both versions. Grading: To successfully earn the accreditation of Certara Certified NCA Analyst  using Phoenix version 8.1/8.2, you need to meet the prerequisites and obtain a minimum passing score of 75% in this update exam.  This update exam has 50 points (questions and software interactions) that validates that you are ready to use Phoenix WinNonlin version 8.1 to do NCA analysis.  The test covers differences between Phoenix WinNonlin version 8.0 and 8.1/8.2 among other general questions.  Previously you should have been certified in the knowledge of NCA analysis on different types of study designs, as well as software proficiency by performing tests related to NCA analysis, data processing, and reporting.  Time Limit:  There a maximum allocated time of 1.5 hours to complete the exam.  The clock starts counting when the user clicks on 'Start Exam'. Exam Content Exam Content:   Successful candidates should have an understanding of fundamental NCA theory and hands-on experience with Phoenix WinNonlin from making plots to summarizing results.  Certification topics include: Exploratory Data Analysis - Data Tools and Plots Performing NCA in Phoenix Post-processing NCA results Click on the image to the right to expand the 'Exam Content' file for a description of each section of the exam and its contribution to the total score.   Accreditation:  This certification is valid for 3 years.  Upon successful completion of the Certara professional certification exam recipients will be issued a digital badge by ACCLAIM. This is a secure, verifiable and standardized delivery method of achievement, and includes all the information about the certification that has been earned, including a detailed description of the exam.  Recipients can opt to make the badge private or public and the earned certification can be listed in a publicly searchable directory.  The eBadges, valid for three years, can be easily embedded on résumés, emails, web sites, and social and professional networking web sites, including and LinkedIn and Facebook.  In addition, a printed certificate of your achievement that includes a verification link can be requested. Read More

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