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Overview
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.
Programme Structure
Courses include
- Fundamentals of Pharmacology and Pharmacokinetics
- Pharmacoeconomics
- Statistical Quality Control
- Drug Development
- Validation of Facilities, Utilities and Equipment
- Biotechnology: Bioprocess Basics
- Pharmaceutical Marketing
- Process Validation
Key information
Duration
- Full-time
- 24 months
- Part-time
- 36 months
Start dates & application deadlines
- Starting
- Apply before
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- Starting
- Apply before
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Language
English
Credits
15 alternative credits
Delivered
On Campus
Disciplines
Public Health Pharmacy Health Sciences View 180 other Masters in Pharmacy in United StatesAcademic requirements
We are not aware of any academic requirements for this programme.
English requirements
We are not aware of any English requirements for this programme.
Other requirements
General requirements
- 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.
Tuition Fee
To alway see correct tuition fees
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International
38214 USD/yearTuition FeeBased on the tuition of 38214 USD per year during 24 months. -
National
38214 USD/yearTuition FeeBased on the tuition of 38214 USD per year during 24 months. -
In-State
35622 USD/yearTuition FeeBased on the tuition of 35622 USD per year during 24 months.
Living costs for Philadelphia
1313 - 2284 USD /month
Living costs
The living costs include the total expenses per month, covering accommodation, public transportation, utilities (electricity, internet), books and groceries.
Funding
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.
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