NUSAGE-Temple University Postgraduate Certificate in Pharmaceutical Manufacturing/Drug Development

Provided by NUS Academy of GxP Excellence


Course introduction

Introduction


Collaboration between NUSAGE and Temple U was established in November 2008.

Temple University, based in the heart of Philadelphia, USA, was founded in 1884. It is a major international university, and a world-class center of teaching, research and health care. It has faculty in 17 schools and colleges, and four professional schools. More information about Temple University itself can be found at http://www.temple.edu/pharmacy_qara/

Temple University offers its Quality Assurance/Regulatory Affairs Graduate Program through the School of Pharmacy. It was the first institution of higher learning to develop a master’s program in Quality Assurance and Regulatory Affairs since 1968, making it the pioneer and leader in this area. With so many decades of experience, Temple University today offers the largest number of comprehensive courses in this discipline, and continues to add courses to incorporate the latest trends in the pharmaceutical/manufacturing industry.

Classes will be held on a part time basis at the Department of Pharmacy, National University of Singapore through a series of live lectures/tutorials, pre-recorded lectures and on-line discussion forum with the faculty at Temple University. A local facilitator will be present at each session to provide guidance and answer queries.

Each module will last around 26 hours, averaging over 13 weeks, 2 hours per week, with tests, assignments and a written examination at the end of the module. Modules are conducted on a part-time basis to facilitate working adults, and may be held on weekday nights or on Saturdays. Completion with a pass grade in the offered modules will confer a NUSAGE Certificate of Attendance.

A participant may wish to complete 4 modules from Temple University in order to be eligible to apply for the post graduate Certificate in Drug Development/Pharmaceutical Manufacturing I from Temple University and NUSAGE. The 4 modules will have to be completed within 3 years, with an average B grade.

The 4 modules required are:

1. PR5301 Food and Drug Laws
2. PR5302 Regulation of Drug Development
3. PR5303 Good Regulatory Practices

And any elective from the below:

4. Unit Operations
5. Regulatory Science
6. Process Monitoring
7. Cleaning Validation
8. Good Clinical Practice
9. Computer Validation
10. High Purity Water Systems
11. Global Medical Device RegulationNUSAGE will roll out these courses in time to come, to meet the training needs of the pharmaceutical industry.



Fees & Funding

Please enquire below for course fees and financial grants:


 

Top