MMS Adds New Inspection and Programming Courses to MMS Academy
MMS Holdings announced that its learning arm, MMS Academy, has expanded its global training portfolio with the launch of new courses in inspection readiness and clinical programming. These new courses will give students and working professionals the opportunity to gain the knowledge that the pharmaceutical, biotechnology, and medical device industries require.
In the 14-week inspection readiness course, students will gain an understanding of global health authority (i.e. FDA, EMA, etc.) inspection processes, 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.
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
