SPRING 2025 - What's New this Semester?

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What makes the RAQA program the best academic program of its kind?  Answer: Our incredibly talented and dedicated faculty, many of whom who have taught for us for 20 or more years, helping to shape and develop the curriculum. With so many excellent instructors from industry and FDA, it would be difficult to name all of them without publishing a small volume about their great courses. Here are a few highlights of our Spring 2025 offerings.  

A new Course on AI/ML for Medical Devices
Dr. Kuehn received outstanding reviews for her course on Patient Focused Regulatory Policy for Medical Products. This spring, she's team-teaching an exciting new course with Dr. Fuh on Artificial Intelligence/Machine Learning for Medical Devices. With emphasis on the U.S. and E.U., this fascinating and complicated subject  explores the rapidly-evolving regulatory space of AI/ML used in numerous medical devices including the challenges posed by these new healthcare products. This course is sure to fill quickly, so register early!  

A well-known expert in vaccines and other sterile products, Professor Casaburi will be offering two of his courses this spring, including Sterilization Processes (5493) and Development of Sterile Products (5501). Don't wait to register: Professor Casaburi will not be teaching this summer, so if you need one (or both) for the Sterile Product Certificate or want to expand your scientific and regulatory knowledge in this area, sign up this spring.

The amazing Professor Bowen returns this spring to offer her fast-paced and ground-breaking course in her specialty of Regulatory Intelligence (5544). Professor Bowen's depth and command of the subject makes class meetings fly by, since you'll be actively engaged in hands-on workshops that will help you to master the tools of increasingly important area of RA.

Learn from one of the pioneers of Regulatory Science by taking Professor Schultz's outstanding course on Regulatory Sciences: Managing the Guidelines for Quality (5575).  Aside from being highly knowledgeable and inspirational, Professor Schultz's fabulous sense of humor brings sparkle and fun to a challenging and important subject.

Don't miss the chance to learn more about the rapidly expanding field of biopharmaceuticals.  RAQA is proud of its outstanding industry professionals with distinguished careers in this area, who continue to teach the latest trends, insights, regulatory and manufacturing issues.  Whether it's Professor Surowitz's course on Vaccines (5572), Professor Casaburi's Pharmaceutical Science courses mentioned about on Sterile Products, or Professor Quinn's course on Global CMCs for Biopharmaceuticals and Other Biologics (5577), make sure you learn from one or more of these excellent instructors.

Professor Saha returns this spring to offer his very popular course on Microbiological Concepts in Pharmaceutical Manufacturing (5512).  Don't miss the chance to strengthen your command of critical QA issues by taking his course, which is only offered once a year.

Professor Zimm will be offering her highly popular course on Critical Analysis of Media Coverage of the Pharmaceutical Industry (5650, section 990).  In addition to reading and analyzing an important book about the pharmaceutical industry, you'll spend classes networking with other students as you develop critical thinking skills that will serve you well throughout your industry career. 

if you miss the camaraderie, networking, and discussions of on-campus courses, consider taking Professor Sax’s new course on Pharmaceutical Regulatory Leadership, which will be offered at our Ft Washington site on Thursday afternoons. It will include networking and stimulating group workshops, designed to help you become a regulatory leader.

Professor Schoneker is a world-renowned expert on excipients and dietary supplements, and he shares his knowledge this spring with his Regulation of Dietary Supplements and Functional Food (5594) course. 

Did you know RAQA created the first certificate and degree programs in Global Pharmacovigilance?  Learn from our amazing professors in this field:  Professor Robinson will offer Risk Management and Safety Signaling of Healthcare Products (5578), Professor Thomas will teach Good Pharmacovigilance Operations (5508), and Professor Cossrow will instruct Pharmacoepidemiology Pharmacovigilance (5573).  A truly outstanding team of experts!  

These are just a few of our many great courses and instructors. WOW!  There are so many more that it's hard to choose.

Have a great semester with Temple's RAQA program.