The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous, and highly complicated. This Graduate Certificate - Biopharmaceutical Manufacturing And Regulatory Affairs from Temple University delves into the complex regulations governing the development, manufacturing, and distribution of such products.
About this Program
Through completion of the certificate, whether post-baccalaureate or post-master's, students understand the following:
- the pharmaceutical science behind the discovery of biotechnology products, including biologics, biosimilars, and biopharmaceuticals;
- the requirements for sourcing and testing materials used in the production of biotechnology products;
- the technologies and unique considerations associated with the manufacturing and distribution of biotechnology products;
- the applicable regulations involved with biotechnology products; and
- the processes used to sterilize biotechnology products, including regulatory requirements for thermal, gaseous, radiation, filtration, and aseptic processing.
- Fundamentals of Pharmacology and Pharmacokinetics
- Statistical Quality Control
- Drug Development
- Validation of Facilities, Utilities and Equipment
- Biotechnology: Bioprocess Basics
- Pharmaceutical Marketing
- Process Validation
- 24 months
- 36 months
Start dates & application deadlines
- Apply before
- Apply before
DisciplinesPublic Health Pharmacy Health Sciences View 180 other Masters in Pharmacy in United States
We are not aware of any academic requirements for this programme.
We are not aware of any English requirements for this programme.
- Master's Degree in Discipline/Related Discipline: Applicants completing the certificate program to earn a post-master's certificate must hold a master's degree in a Pharmacy-related field.
- Bachelor's Degree in Discipline/Related Discipline: Applicants completing the certificate program to earn a post-baccalaureate certificate must hold a B.S. degree in Biochemistry, Biology, Chemistry, Physics, or a health-related discipline.
International38214 USD/yearTuition FeeBased on the tuition of 38214 USD per year during 24 months.
National38214 USD/yearTuition FeeBased on the tuition of 38214 USD per year during 24 months.
In-State35622 USD/yearTuition FeeBased on the tuition of 35622 USD per year during 24 months.
Living costs for Philadelphia
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.
Apply and win up to €10000 to cover your tuition fees.