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Validate Your Expertise in PK/PD NCA Analysis Through Certara Professional Certification

In the ongoing commitment to education and coinciding with the launch of Phoenix 8.1, Certara has introduced a new certification program available through Certara University. The new online accreditation program validates the scientists’ PK/PD data analysis skills using Certara software such as Phoenix WinNonlin and expands their professional reach. I caught up with Ana Henry, Certara’s Executive Director of Training, to get her overview on Certara University, the Certara Professional Certification program, and find out what’s in store for the future.

Maria Saluta: Before we delve into the Professional Certification program, let’s talk about your background in PK/PD and how you became involved in Certara University.

Ana Henry: After obtaining an MS in biomathematics from North Carolina State University, I worked as a statistician for Quintiles (now IQVIA) for several years. While at Quintiles, I was mentored in pharmacometrics and PK/PD by Dan Weiner, who was head of the statistics department, and I ultimately started doing solely PK/PD analysis in the PK/PD department. I pursued an opportunity as manager of the PK/PD department and, in 2002, joined Pharsight (now Certara) as a trainer, pre-sales rep, and head of the support department. Since joining Certara, I have held several roles including product manager for all PK/PD products, including Phoenix. Currently, I am the head of Certara University. Teaching is my passion, and I am thoroughly enjoying this new endeavor at CU.

MS: For those who may not be familiar with Certara University (CU), can you explain when, how, and why CU started?

AH: Certara has always recognized the importance of training as it enables our software users to best utilize the tools available to them and to become their most effective. Prior to 2016, we only offered classroom courses available in public venues or at client sites. We realized that people like to learn in different ways, and many clients were interested in online options. Professionals do not have time to attend long classes or even workshops. They might have educational gaps that they want to fill due to changes in the industry as well as the rapid development of PK/PD software tools. It is easier to find 30 minutes a day to learn from anywhere, and at any time, than to attend in-person courses. There was an increased need in emerging countries for training, but it was challenging for both our customers and ourselves to travel to destinations where classes were taught.

So in 2016, Certara University was officially “born” and initially started by offering our classroom workshops in an on-demand or online setting. Courses are taught with short videos that are, at most, 15 minutes long. Quizzes and knowledge assessments given throughout the course keep users engaged. The courses are oriented to practical knowledge through exercises that users perform on their own. We also provide solution videos to exercises. Users can ask questions, exchange knowledge, and keep informed of other available training through the platform.

MS: Describe the curriculum offered by CU.

AH: Certara University offers a variety of formal training that is pertinent for acquiring specific knowledge and hands-on experience for analysis and reporting using Certara software, eg, Phoenix WinNonlin, Phoenix NLME, Simcyp, and other software platforms. CU also provides theory courses on topics that do not require knowledge of a specific software, eg, fundamentals of PK, non-compartmental data analysis, R, and other courses that expand one’s PK/PD knowledge. The online courses are based on top-down PK/PD analysis and divided into two paths, each with introductory, intermediate, and advanced courses: (1) Individual PK/PD data analysis using rich data per individual and (2) Population PK/PD data analysis combining rich and sparse sampling per individual using non-linear mixed effects modeling (NLME) and Phoenix NLME. There are also peripheral offerings that are more specialized that might apply to a certain group of analysts, like a course in time delays or IVIVC.

MS: Let’s talk about the Certara Professional Certification program. How did the idea of a certification program arise?

AH: Through our consulting interactions with biopharmaceutical companies and regulatory agencies and by supporting our software customers, we recognized that being able to demonstrate proficiency in PK/PD analysis using Phoenix is an asset for employers as well as professionals. Having a strong foundation in PK/PD expertise minimizes the time to bring people up to speed; our discussions also uncovered the need for training and for helping to close the knowledge gap on specific modeling and simulation (M&S) topics. Our certification program does not require people to take prior training at Certara University and provides a formal verification of knowledge. Certifications also promote individual skills and achievements. A recent poll of scientists confirmed a strong interest in participating in this certification program since it would not only validate their knowledge and skills but also identify gaps in their knowledge and help them learn.

MS: What current certifications are offered in the program?

AH: CU launched the certification program in June with the focus on pharmacometrics. The first certifications—Phoenix WinNonlin NCA Analyst—accredits users on NCA analysis using Phoenix WinNonlin versions 8.0 and 8.1. In the future, we will offer additional certifications in modeling and simulation.

MS: What topics are covered in the exam, and how is it structured?

AH: The certification exam is rigorous and comprehensive. It is comprised of 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. To be certified as an NCA analyst using Phoenix WinNonlin, users need to understand how, why, and when to perform NCA. For example, being able to perform analysis and interpret the PK parameters for several study designs like toxicokinetics, single dose studies, multiple dose studies, fed-fasted studies, etc. Examinees should be proficient in doing NCA analysis using Phoenix WinNonlin, including the NCA module, graphics, data manipulation, and tables. There is also a section that tests knowledge of non-parametric superposition. The exact topics that are being covered will be available to users prior to registering for the exam.

MS: How is the exam taken, and how is certification achieved?

AH: Grading is instantaneous. Accreditation requires a minimum passing score of 75% for each part of the exam; each registration includes 2 attempts to pass the exam. Certifications are valid for 3 years after passing the exam.

MS: Are there any prerequisites required or recommended and how can one get ready for the exam?

AH: A working knowledge of English is recommended since we don’t offer exams in other languages. Although no prerequisites are required to take the Phoenix Certified NCA Analyst certification accreditation, several CU courses or having equivalent experience can help to prepare for the certification: Fundamentals of Pharmacokinetics (103-OD), Non-compartmental Data Analysis (105-OD), and either the On Demand (100-OD) or Classroom (100-CL) Introduction to Phoenix WinNonlin.

MS: Can modelers using previous versions of Phoenix take the certification?

AH: We believe that users of Phoenix WinNonlin from previous versions, eg, Phoenix 7.0 and earlier, can pass the certification exam if they review the new features of versions 8.0 or 8.1 carefully. CU will provide resources for this review.

MS: What do attendees receive upon successful completion of the certification?

AH: Upon successful completion of the Certara Professional Certification exam, recipients will be issued a digital badge through Credly Acclaim. Certara has partnered with Credly Acclaim, a leader in badge technology, to provide secure badges that can be embedded in résumés, emails, corporate websites, and social and professional networking websites including Facebook and LinkedIn. This secure, verifiable, and standardized delivery method of achievement includes information about the certification that has been earned, including a detailed description of the exam. Recipients can make the badge private or public and can list the earned certification in a public searchable directory. In addition, recipients can request a printed certificate of achievement that includes a verification link.

MS: From your perspective, who should consider taking the certification, and how does becoming a Certara Certified Phoenix NCA Analyst benefit recipients?

AH: The NCA analyst certification should be taken by people wishing to demonstrate knowledge in this area. This can include professionals wanting to demonstrate knowledge in the analysis of PK data in pre-clinical and clinical departments, students seeking employment who want to certify their PK knowledge, or scientists who may be required to demonstrate proficiency with new versions of Phoenix WinNonlin. In regards to benefits, the certification validates their knowledge and expertise in NCA analysis. Achieving certification also demonstrates domain knowledge, proficiency in WNL, ensures qualification that they can perform the job/task, and is valuable for career advancement. From an employers’ perspective, hiring modelers skilled in the current version of state-of-the art NCA software results in attaining productivity faster.

MS: Do you plan to expand the offering to other areas?

AH: Several more certifications are planned to become available in the future. If you need certifications in a specific area of modeling and simulation, we want to know about it—email us at info@certarauniversity.com.

MS: How can people who are interested in getting certified on Phoenix 8.0/8.1 learn more about the program?

AH: To learn more and to register for the program, visit Certara Professional Certification.

Want to learn more about the new features in Phoenix 8.1 and Certara Professional Certification? Watch this webinar by my colleagues Nathan Teuscher, Venkateswari Muthukrishnan, and Ana Henry.

About the author

By: Maria Saluta

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