Fall 2024 - What's New this Semester? | Order texts on-line via |
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 Fall 2024 offerings. A new Course on Patient-Focused Policies Dr. Kuehn received outstanding reviews from students taking her new course on Patient Focused Regulatory Policy for Medical Products (RAQA 5504) this summer, so we're offering it again this Fall on Thursday nights. You'll learn so much about this innovative topic starting with the U.S. patient-focused policies initiated by the FDA and compare them to similar efforts in Canada, Australia, and the European Union. Current literature related to patient engagement, preferences and experiences will be explored, so you'll gain a better understanding of the subtle methodologies and policy-specific differences between those concepts. Whether you're involved with clinical trials, pharmacovigilance or RA, don't miss this chance to learn cutting-edge thinking in this area. We're also pleased to offer two great RAQA courses this Fall that have been revamped and redesigned -- and taught by two outstanding instructors: : 1) Regulatory Aspects of Biomedical and Regulatory Communication (5534), taught by Professor Arbaugh. If you enjoyed his unique course on eRegulatory Submissions, don't miss the chance to explore the many types of regulatory and technical writing required by industry. His course will discuss the concept of "Quality" regulatory writing, exploring everything from content to strategy to style and filing and review timelines. Ultimately, the ability to express oneself correctly, concisely and within the specific requirements of regulatory guidelines is critical to a successful industry career. We highly recommend this seminal course for industry professionals. 2) Good Distribution Practices (5543), taught by Professor Hayes. This course will focus on the many issues and concerns around Supply Chain Issues with both a U.S. and global focus. In addition to addressing the specific regulations, guidelines and best practices related to the shipment and storage of pharmaceutical products, the underlying theme of this course will explore the modern challenges posed in maintaining the integrity of a global supply chain. What is Qualified Storage Design? What qualifications must be considered when considering warehouse and storage issues? Who is ultimately responsible in a global supply chain? You'll discuss these topics and more in this excellent course. KENX is offering new venues for students across the U.S. to pursue their conferences. This fall, KENX will be offering Temple-track conferences in RTP and Washington, DC. Many students are discovering how taking one online RAQA course plus one KENX conference in the fall and another in the spring is a convenient way to accelerate their completion of the RAQA MS program. Check out the topics on KENX.org.conferences. Don't miss the chance to learn more about the rapidly expanding field of biopharmaceuticals. RAQA has so many 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 Diana's course on Biologics and Biosimilars (5515), Professor Surowitz's course on Vaccines (5572), Professor Casaburi's Pharmaceutical Science course on the Production of Sterile Products (5492), 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. 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 Tuesday afternoons. It will include networking and stimulating group workshops, designed to help you become a regulatory leader. Interested in Validation? Don't miss Professor Barnthouse's excellent Process Validation course (5474) and his great sense of humor or Professor Preziosi's encyclopedic course and knowledge about Computerized Systems Validation (5498). Professor Schoneker is a world-renowned expert on excipients, and he shares his knowledge this fall with his Global Excipient Regulations (554) 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 Clinical Drug Safety and Pharmacovigilance (5538), Professor Thomas will teach Good Pharmacovigilance Operations (5508), and Professor Ward will instruct Regulatory and Legal Basis of Pharmacovigilance (5579). An 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 fall semester with Temple's RAQA program.
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