Regulatory Affairs News & Announcements

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Upcoming Regulatory Affairs Events

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The Master of Regulatory Affairs program (MRA) and Regulatory Affairs Certificate are accepting applications for the Fall 2024 academic year. These are online graduate-level programs designed to prepare professionals to play key roles in bringing innovative products to market while also ensuring that products are safe and effective. Graduates will be trained in the skills necessary to maximize compliance and minimize risk in the development of FDA-regulated products and will learn both the foundation and application of science-based clinical investigation and corresponding regulations.   

Our online program and certificate allow for increased flexibility for working professionals while continuing to offer students a robust and engaging curriculum, build and foster engaging relationships amongst peers and faculty, and prepare graduates for the next step in their career. 

Join Program Director, Andrew Fesnak, MD, MHCI, and program alumni for a 1-hour virtual interest session to learn more: Friday March 22, 2024 at 12 pm Eastern time.

You may register for the session via Zoom. 

MRA & RA Certificate applications are due by May 1, 2024. For more information, please visit the REG programs overview.  

 Flyer for the symposium, details below

Ajay Parashar Memorial Symposium: Cutting Edge Technologies and the Evolving Landscape of the Regulatory Field 

Date: Thursday, April 20, 2023, 3-5 p.m.

Zoom Registration Link

Please join us for the inaugural symposium in dedication of Ajay Parashar, PharmB, MS, MDD, RAC. Ajay was a beloved instructor and mentor in the MRA program always championing innovation.  

The symposium will feature 3 presentations focused on the current regulatory landscape and how the landscape intersects with cutting-edge therapeutic and diagnostic technologies. We will conclude with a panel discussion on the evolution and future direction of regulatory pathways.   

Presentations  

  • Gene Editing, Julie K. Jadlowsky, Ph.D 

  • Artificial Intelligence, Monica Ferrante, MS, MPA, DPA 

  • 3D Printing, Carly Stein, MS, MRA Alumni  

Julie K. Jadlowsky, Ph.D is the Director of Translational Science Operations in the Center for Cellular Immunotherapies at the University of Pennsylvania, Philadelphia, USA.  She studied HIV transcriptional regulation at Case Western Reserve University, where she completed her Ph.D. in Molecular Biology and Microbiology.  She joined the University of Pennsylvania in 2010 as a postdoctoral scholar studying high affinity T cell receptors in HIV.  Since leaving the bench in 2013, her focus has been on translating genetically modified adoptive cell therapies developed in the research laboratories into first-in-human clinical trials for oncology and infectious disease indications.  As Director of Translational Science Operations, she is responsible for oversight and strategic direction related to the opening of investigational new drug applications focused on genetically modified T cells. 

Monica Ferrante is a Regulatory, Quality & Clinical executive who has worked for and consulted with medical device companies across a broad spectrum of products with both start-ups and large multi-national corporations.  She has experience with all regulatory processes related to the development, submission, market clearance and post approval requirements for devices and combination products. She has also supported several Clinical Studies with regards to regulatory requirements, clinical trial database registrations, and FDA Investigations of clinical sites, adverse event review and study documentation. Education includes a BS in Biomedical Engineering, MS in Physiology, MPA and DPA in Public Policy. One Patent issued. 

Carly Stein, a recent Penn alum, completed her first Master’s degree in Regulatory Affairs at Penn in 2022. A scientist by training with many years spent at the bench studying basic molecular science, she transitioned into the world of clinical research a few years prior where she worked as Sponsor Data Manager of CAR T cell therapy clinical trials. Shortly promoted to Sr. Clinical Trials Project Manager, Carly now manages the operations of first-in-human cancer immunotherapy CAR T cell trials in the Center for Immunotherapies. Carly recognized that an education in regulatory affairs would benefit her understanding of how human research is conducted safely and responsibly. Carly is also working towards her second Master’s degree in Law, which compliments the MRA by providing statutory context to the regulations and the regulatory bodies that govern, and she is expected to graduate in May 2023. Carly hopes to continue working in the CAR T cell space, providing innovative, personalized cell and gene-based therapies to patients in the fields of cancer, autoimmune disease, infectious disease, and organ and bone marrow transplantation, a mission that resonates deeply with her. 

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