About the Certificate
The post-master's certificate in Generic Drugs studies the topics that are unique to generic drug manufacturers. Courses focus on the regulatory issues that are critical for generic industry professionals to understand if they are to ensure that their companies create safe and effective bioequivalent drugs. Coursework delves into the global business environment of generic therapeutic products and pertinent domestic and global regulations. Starting with an overview of the drug development process for innovator products, the required courses compare and explore the Abbreviated New Drug Application (ANDAs) used for generics. Elective courses enable students to explore various manufacturing and regulatory issues, including current trends in the global marketplace regarding APIs and excipients. The certificate allows students to sharpen their knowledge of this industry niche.
The Generic Drugs certificate provides the tools and information to understand how generic drugs are regulated locally, nationally and globally. Students become familiar with:
- domestic and global regulations for generic products,
- the highly competitive environment of generic products,
- manufacturing issues of global products, and
- current regulatory filing and quality assurance issues affecting generic products.
Time Limit for Certificate Completion: 4 years
Campus Location: Online and Fort Washington
Full-Time/Part-Time Status: The post-master's certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.
Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.
Admission Requirements and Deadlines
Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.
APPLY HERE to the post-master's certificate program.
Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field.
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biology, Chemistry, Engineering, Pharmacy, Physics or related field.
Certificate Requirements
Number of Credits Required to Complete the Certificate: 12
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| QARA 5459 | Drug Development | 3 |
| QARA 5473 | Generic Drug Regulation (ANDAs) | 3 |
| Electives | ||
| Select two from the following: | 6 | |
| Solid Dosage Forms - Small Molecules | ||
| Global Biopharmaceutical Industry | ||
| Good Manufacturing Practices | ||
| Active Pharmaceutical Ingredients (APIs) | ||
| Good Distribution Practices | ||
| Global Pharmaceutical Excipient Regulation | ||
| Global CMC Issues and Regulatory Dossier | ||
| Special Topics in Regulatory Affairs and Quality Assurance | ||
| Analytical Chemistry in Pharmaceutical Laboratories | ||
| Total Credit Hours | 12 | |
GPA Required to be Awarded the Certificate: 3.0 minimum
Contacts
Certificate Program Web Address:
Department Information:
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728
267-468-8560
Mailing Address for Application Materials:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728