What's New this Summer Semester? (RAQA)


Summer 2024 - 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 Summer 2024 offerings.  

Two new courses this summer!

We welcome Dr. Kuehn, who will be offering a new course on Patient Focused Regulatory Policy for Medical Products (RAQA 5650) on Thursday nights.  She will cover U.S. patient-focused policies initiated by the FDA and also survey similar efforts in Canada, Australia, and the European Union. Importantly, students will review current literature related to patient engagement, preferences and experiences to 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. 

Dr. Zimm is also offering a new Special Topics course for 1.5 credits between July and early August.  Titled Critical Case Study Analysis of Mainstream Pharmaceutical Literature, this course will focus on recently published works of non-fiction which highlight events and cases involving the pharmaceutical industry. Students will read, analyze and discuss the impact these works have on everyone involved in the regulated pharmaceutical industry (employees, health authorities, healthcare professionals, patients, and graduate students in RAQA). Meeting just 6 Tuesday evenings between July 2 and August 6, it's a great way to earn graduate credits while also enjoying stimulating discussions with other RAQA students about very current media coverage and issues.  To learn more: https://temple.zoom.us/rec/share/8E18qA7JtVs_yu9VyiZM-FYe4uGXc8nFFDuJnMLs3CTlk5n_1GQ8N5UFY9cwhM1C.i6VmGJY8jeAVKekO

We welcome back several excellent instructors, who will offering courses in their specialties, including:

William Collentro, one of the world's foremost authorities on pharmaceutical water systems. Enjoy the privilege of learning from a true expert in this very complicated by crucial area of manufacturing, who wrote one of the most comprehensive books on the subject.  High Purity Water Systems (RAQA 5478) is offered on Tuesday nights, and the required book is available online (for free) in Temple's Charles Library for all RAQA registered students.  

Professor Wilson, who will teach her highly energetic and insightful course on Good Laboratory Practices on Wednesday evenings.  A graduate of Temple's RAQA MS degree, Professor Wilson is familiar with the critical role that Temple's RAQA courses have had in advancing careers in the pharmaceutical, biopharmaceutical, and medical device industries, as well as the powerful networking that the RAQA faculty, students, and graduates share.  While her course provides a thorough review of GLP regulations, she also shares first-hand accounts on why they are so important to drug development. 

Professors Cronenberger and Sweeney will teach Fundamentals of Pharmacology and Pharmacokinetics (RAQA 5401) on Wednesday nights. Both are experts in this field, having worked at one of the world's largest pharmaceutical companies in these areas.  Learn from two experts who know both the pharmaceutical science and regulatory issues affecting drug development.

Professor LoGalbo will offer a Sunday section of Food and Drug Law, blending lecture with active class discussions.  A practicing lawyer in industry for several decades, her course will focus on the practical application of key aspects of the Food, Drug and Cosmetic Act, which every RAQA student needs to know for a successful career in industry.  Students have always enjoyed how her course reflects current practices and her excellent teaching style.

Don't forget that you can also earn 1.5 credits this summer by attending one of KENX's outstanding conferences in either San Diego, CA, or Philadelphia, PA.  The three summer conferences (RAQA 5000) will focus on Validation, Analytical Method Development, Cleanroom Contamination Control and Environmental Monitoring.  For more information on each conference, visit www.kenx.org/conference or call the RAQA Office for information on how to earn credits while enjoying the great KENX sessions.

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 Wednesday afternoons. It will include networking and stimulating group workshops, designed to help you become a regulatory leader.

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 summer semester with Temple's RAQA program.