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Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy

About Regulatory Affairs and Quality Assurance at the Temple University School of Pharmacy

Thank you for your interest in the Regulatory Affairs and Quality Assuarnce graduate program of Temple Universityís School of Pharmacy. 

Our program is the most established and omprehensive graduate academic curriculum of its kind.  Our program fulfills regulatory requirements for training and helps professionals in industry expand their critical thinking skills in regulatory and quality issues for career advancement.

Experts from the U.S. FDA and the regulated industries of pharmaceuticals, medical devices, and biosimilars and biotechnology teach our classes.  With over 100 faculty, hundreds of companies are represented. A major reason the program has become so successful is the strength of our faculty.  They share their tremendous hands-on experience with our students in small classes, encouraging insightful dialogues about industry practices and current regulations.

The majority of our students are from the regulated industries of pharmaceutical, medical devices, biotechnology, biosimilars, representing nearly every major corporation across the nation. Other students are from related firms such as pharmaceutical support, food and chemical companies, and the healthcare arena. Many also work for key regulatory agencies. The experience and knowledge of the students vary considerably. Some are new to the industry while others have been there for decades. The synergy of newcomers and veterans affords students the benefit of repeated networking opportunities.

Temple University was the first institution of higher learning to develop a masterís program in Quality Assurance and Regulatory Affairs in 1968.  With five decades of experience, we offer the largest number of courses in these disciplines and continue to add courses to incorporate the latest trends.

Our curriculum provides a thorough grounding in the drug development process and exposure to domestic and international regulations combined with quality principles and practices. 

The core courses (Drug Development, Food and Drug Law, Good Practices, and Quality Audit or IND/NDA Submissions) provide students with a strong foundation in fundamentals or the industry.

Electives (such as Global CMC and the Regulatory Dossier, High Purity Water Systems, or Regulatory SciencesManaging the Guidelines for Quality) enable students to delve deeper into specific areas. 

Certificates enable students to specialize in key areas, such as Clinical Trial Management, Medical Devices, or Biologics. Whether you wish to pursue a program in Regulatory or Quality issues, we have numerous courses in both disciplines.

Pharmaceutical science electives (such as Biotechnology) broaden students' technical knowledge. Those interested in manufacturing will also find numerous courses in all aspects of quality, including the new certificate in GMPs for the 21st Century.

Temple University continues to be the pioneer in this educational field.  Our School of Pharmacy was the first to create certificate programs. It was also the first school to launch certificates in Medical Devices, Generic Drugs, GMPs for the 21st Century, and Global Pharmacovigilance.  The broad curriculum gives students many choices to explore multiple industry disciplines, expanding their career options. 

Students may: 

        enhance their knowledge of the pharmaceutical industry by taking one course or more;

        complete a certificate in a specific area, so they have credentials;

        pursue the entire MS, either mixing QA and RA courses or targeting their chosen electives in a specific aspect of the industry (Quality or Regulatory or clinical trials or pharmaceutical sciences, etc).

Temple allows students to explore the program by taking a maximum of three courses before formally matriculating into the Master of Science.  Students are also welcome to earn one of our certificates on their way to the masterís, counting all of the credits earned as part of the MS.

We offer information sessions at our Open Houses each semester, or are happy to visit your pharmaceutical site to speak about our unique program.  Contact for more information.

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