News
The USC-Asia Pacific Economic Cooperation (APEC) Center of Excellence is pleased to host a program entitled “Harmonizing Medical Device Regulation” on October 12-13, 2023 at the USC Health Sciences Campus. This meeting brings together regulators from over 10 countries from APEC economies across the globe to train them in medical device regulations.
Three faculty in regulatory and quality sciences received URAP awards as lead investigators to engage undergraduate students to research topics in the regulatory science and translational research disciplines.
Three PharmD candidates with excellent academic standing and an enduring commitment to advancing pharmaceutical research under regulatory science faculty mentorship were awarded the Dean’s PharmD Summer Research Fellowship. Congratulations to these students! Learn more
Please join Dr. Pacifici in congratulating Cheryl Hergert on the successful defense of her dissertation, “Use of Electronic Health Record Data for Generating Clinical Evidence: A Summary of Medical Device Industry View.” Congratulations, Dr. Hergert!
Please join Dr. Kuo in congratulating Ronald Lillie on passing his qualifying exam, Implementation of GVP IX for Postmarketing Signal Management in the Bio-Pharmaceutical Industry. Welcome to the doctoral candidacy Ron!
Please join Dr. Richmond in congratulating Anjali Malhotra on the successful defense of her dissertation, “21 CFR Part II Compliance for Digital Health Technologies in Clinical Trials.” Congratulations, Dr. Malhotra!
Please join Dr. Richmond in congratulating Laura Kupsch on the successful defense of her dissertation, “Contract Research Organizations – A Survey of Industry Views and Outsourcing Practices.” Congratulations, Dr. Kupsch!
Please join Dr. Richmond in congratulating Martin Koning-Bastiaan on the successful defense of his dissertation, “Institutional Review Board Implementation of the Single IRB Model for Multicenter Clinical Trials.” Congratulations, Dr. Koning-Bastiaan!
Please join Dr. Richmond in congratulating Hai Luong on the successful defense of his dissertation, “Regulatory CMC Strategies for Gene and Cell Therapies During Mergers and Acquisitions: A Survey of Industry Views.”
USC Mann School Department of Regulatory and Quality Sciences adjunct professor, Roger Clemens, DrPH, has added five more publications to his running list of more than 80 manuscripts on nutrition, food science, and toxicology.
Research in regulatory science has far-reaching impacts ranging from patient-specific clinical effects to policy-wide public health implications. This is the case for Harlan Tsui’s research project, which won first place in the undergraduate/master’s level group at the 2022 Early Career Addiction Science Showcase.
Three PharmD candidates with excellent academic standing and an enduring commitment to advancing pharmaceutical research under regulatory science faculty mentorship were awarded the Dean’s PharmD Summer Research Fellowship. Congratulations to these students!
Regulatory science student-researchers and alumni presented their work at Translational Science 2022, hosted by the Association for Clinical and Translational Science (ACTS).
Students, faculty, and staff from the USC Department of Regulatory and Quality Sciences participated in the Drug Information Association (DIA) Global Annual Meeting in Chicago, Illinois—the first DIA in-person global convergence since the start of the pandemic.
James Wabby, MHMS, Doctor of Regulatory Science candidate and Adjunct Assistant Professor at the Department of Regulatory and Quality Sciences co-published an article on challenges and opportunities posed by emerging digital health technologies.
Read Dr. Clemen’s latest article, No Smell, No Taste—Dealing With a “Senseless” Phase of the Pandemic, in Nutrition Today.
A unique aspect of the Doctor of Regulatory and Sciences (DRSc) program at the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences is the opportunity to travel throughout Europe or Asia to meet international regulators and learn about global regulatory strategy. Over the course of two weeks, the incoming Fall 2022 cohort visited Vietnam, Singapore, and Thailand, gaining valuable experience in presenting to a global audience and submerging themselves into the global aspects of regulatory science, all while developing a lasting bond that will endure throughout their journey as the next DRSc cohort.
USC Faculty from the Department of Regulatory and Quality Sciences were interviewed by Phoenix TV, a Chinese television station, about the interdisciplinary education agreement between the USC and National Cheng Kung University (NCKU)in Taiwan. Dr. Frances Richmond, Dr. Pacifici and Dr. Benson Kuo talked about the importance of interdisciplinary efforts between biomedical sciences and regulatory science to improve global health.
LOS ANGELES / TAINAN, TAIWAN – The University of Southern California (USC) and National Cheng Kung University (NCKU) announced on May 24 a partnership that creates new educational opportunities for NCKU students in the growing, high-demand fields of regulatory science and biomedical engineering.
The 2022 Innovation in Regulatory Science Award was
presented to Weicheng Wu, MS ’03, vice president of Global Regulatory Affairs for ASC Therapeutics, Inc., where he leads the preparation and submission of investigational new drug applications (INDs) for gene and cell therapy products and interaction with global regulatory authorities.
Frances Richmond, Director of the USC-APEC Center for Training Excellence, was a member of the program committee and a moderator of panel discussions for the 2021 AHC-SCH Medical Device Forum, held virtually October 14 and 21st on line, as part of joint activities with the Soonchunhyang University (SCH) APEC Center of Training Excellence, and the APEC Harmonization Center, in Korea. This program allowed several USC graduate students in regulatory science to attend and learn about global regulatory management of digital technologies and in vitro diagnostic devices during the current pandemic and in the future.
Click the image below or HERE to view the full agenda of the event.
Our doctoral graduates continue to use their academic capabilities! Be sure to check out the roadmap that Neal Storm and his colleagues have constructed in this paper. It describes how real-world data can be used instead of clinical bridging studies for registration in China. Read the article HERE.
Find this and lots of other articles and white papers by our alumni and faculty HERE.
Go to our Articles page and read the new piece written by former RegSci student Dr. Lori Alquier with Dr. Frances Richmond, “Streamlining processes – the WHO Collaborative Procedure for Accelerated Registration in Africa”.
Published in the September issue of TOPRA’s “Regulatory Rapporteur”. Congrats Dr. Alquier!