Post-Master's Certificate: Generic Drugs

SCHOOL OF PHARMACY

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: Fort Washington

Full-Time/Part-Time Status: The 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 fields.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 12

Required Courses:

Core Courses
QARA 5459Drug Development3
QARA 5473Generic Drug Regulation (ANDAs)3
Electives
Select two from the following:6
Pharmaceutical Manufacturing II
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 Hours12

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/certificate-programs/post-masters-certificates/generic-drugs-certificate

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

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

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Program Coordinator

qara@temple.edu

267-468-8560