CANTON TWP.—Officials at MMS Holdings, the Canton Township-based contract pharmaceutical research firm, announced that the company’s MMS Academy has launched new courses in inspection readiness and clinical programming for clinical trials.
Officials said the new courses—created by industry experts—will give students and working professionals the opportunity to gain the critical knowledge that the pharmaceutical, biotechnology, and medical device industries require.
In the 14-week inspection readiness course, students will gain an understanding of the inspection processes of global health authorities like the U.S. Food and Drug Administration and the European Medicines Agency, targeted industry-specific guidance, and important regulations and guidelines that allow teams to ensure successful regulatory authority inspections.
Mini courses are also available, each lasting three to four hours, and have been prepared with consideration for a variety of specific inspection needs, including remote inspections, regulatory agency and ISO basics, post inspection management, GMP, sponsor and CRO inspections, and more.
“Preparing for regulatory inspections is essential in our industry, creating a critical need to have actionable, tested training for life sciences professionals at all levels,” said Michelle Gayari, executive vice president for global operational excellence and innovation at MMS. “Being unprepared for one inspection is all it takes to greatly delay a new drug or therapy. The skills of those who take this course are set to gain will help prepare them for successful inspections and a more successful future.”
Hands-on clinical programming coursework
Intermediate Fundamentals of Clinical Programming, an 8-week course, is designed for intermediate SAS programmers looking to learn more about the CDISC SDTM model. Those taking this course will gain the confidence to model clinical trial data into SDTM domains and a level of expertise to draw upon when engaged in real-world projects.
This course provides an understanding of:
- Converting clinical data into SDTM format by understanding the required modeling of the General Observation Class and targeted domains
- The components included in define.xml v2.0
- The process of third-party validation of the define application
- How to resolve and apply corrective measures to ensure modeling is in compliance with SDTM standards
“Traditional colleges will teach students how to program, but few teach how to support the needs of our industry specifically,” said Jim Bademian, director of statistical programming and data management at MMS. “Many learn that on the job, and MMS Academy is here to help speed up that real-world learning process to create stronger programmers.”
MMS Academy continuously works to expand its global training portfolio for students and working professionals. New courses on data science and pharmacovigilance are planned to launch later this year.
Sign up for courses on inspection readiness, programming, or any of MMS Academy’s other virtual learning offerings by visiting www.mmsacademy.com. Use the discount code GETSTARTED50 at checkout for 50 percent off any one course, valid until Aug. 31.
For more information, visit www.mmsholdings.com.