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The post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) specialists to receive formal recognition for studying the highly specialized, rapidly growing field of pharmaceutical biotechnology, which includes the manufacturing techniques and applicable regulations used in the development and production of biotechnology products. The first biopharmaceutical product, namely, recombinant human insulin, was approved in 1982. Since then, products derived through biotechnology have provided advances in medicine that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. This certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
Through completion of the certificate, 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 overview
Main Subject
Pharmacy and Pharmacology
Degree
Other
Study Level
Masters
Study Mode
On Campus
The post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) specialists to receive formal recognition for studying the highly specialized, rapidly growing field of pharmaceutical biotechnology, which includes the manufacturing techniques and applicable regulations used in the development and production of biotechnology products. The first biopharmaceutical product, namely, recombinant human insulin, was approved in 1982. Since then, products derived through biotechnology have provided advances in medicine that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. This certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
Through completion of the certificate, 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.
Admission Requirements
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 Biochemistry, Biology, Chemistry, Physics or a health-related discipline.
Jan
Aug
Scholarships
Selecting the right scholarship can be a daunting process. With countless options available, students often find themselves overwhelmed and confused. The decision can be especially stressful for those facing financial constraints or pursuing specific academic or career goals.
To help students navigate this challenging process, we recommend the following articles:
Biopharmaceutical Manufacturing and Regulatory Affairs Post Master's Certificate
# 351-400QS Subject Rankings
Pharmacy and PharmacologyMain Subject Area
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
Other
Study Level
Masters
Study Mode
On Campus
The post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) specialists to receive formal recognition for studying the highly specialized, rapidly growing field of pharmaceutical biotechnology, which includes the manufacturing techniques and applicable regulations used in the development and production of biotechnology products. The first biopharmaceutical product, namely, recombinant human insulin, was approved in 1982. Since then, products derived through biotechnology have provided advances in medicine that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. This certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
Through completion of the certificate, students understand the following:
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
Other
Study Level
Masters
Study Mode
On Campus
The post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) specialists to receive formal recognition for studying the highly specialized, rapidly growing field of pharmaceutical biotechnology, which includes the manufacturing techniques and applicable regulations used in the development and production of biotechnology products. The first biopharmaceutical product, namely, recombinant human insulin, was approved in 1982. Since then, products derived through biotechnology have provided advances in medicine that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous and highly complicated. This certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
Through completion of the certificate, students understand the following:
Admission Requirements
Scholarships
Selecting the right scholarship can be a daunting process. With countless options available, students often find themselves overwhelmed and confused. The decision can be especially stressful for those facing financial constraints or pursuing specific academic or career goals.
To help students navigate this challenging process, we recommend the following articles:
How to get a full scholarship
Looking for a fully-funded scholarship to see you into university? Find out how to boost your chances of getting one.
Scholarships to study abroad
Find scholarships to study abroad with our lists of international scholarships – categorized by country, by subject, and by type of student.
Scholarship Applications: Frequently Asked Questions
Get answers to all your questions about scholarship applications, including tips on how to find scholarships and chances of success.
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Neuroscience Graduate Certificate
Political Science MA
Political Science MA
Professional Health Education Graduate Certificate
Professional Health Education Graduate Certificate
Public Health Data Science MS
Public Health Data Science MS
Public Health Law Research Graduate Certificate
Public Health Law Research Graduate Certificate
Public Policy Graduate Certificate
Public Policy Graduate Certificate
Public Policy MPP
Public Policy MPP
Public Relations Graduate Certificate
Public Relations Graduate Certificate
Scientific Writing PSM
Scientific Writing PSM
Secondary Education MEd
Secondary Education MEd
Social Work MSW
Social Work MSW
Social and Behavioral Sciences MPH
Social and Behavioral Sciences MPH
Sociology MA
Sociology MA
Special Education MEd
Special Education MEd
Strategic Communication and Cross-Cultural Leadership Graduate Certificate
Strategic Communication and Cross-Cultural Leadership Graduate Certificate
Student Affairs Leadership Graduate Certificate
Student Affairs Leadership Graduate Certificate
Superintendency Graduate Certificate
Superintendency Graduate Certificate
Teaching English to Speakers of Other Languages (TESOL) MSEd
Teaching English to Speakers of Other Languages (TESOL) MSEd
Teaching in Higher Education Graduate Certificate
Teaching in Higher Education Graduate Certificate
Trial Advocacy and Litigation Juris Doctor Certificate
Trial Advocacy and Litigation Juris Doctor Certificate
Urban Education Graduate Certificate
Urban Education Graduate Certificate
Urban Education and Policy MEd
Urban Education and Policy MEd
Executive MBA (4)
Executive MBA
Executive MBA
Full-Time MBA (4)
Full-Time MBA
Full-Time MBA
Online/Distance MBA (4)
Online MBA
Online MBA
Part-Time MBA (4)
Part-Time MBA
Part-Time MBA
Arts and Humanities (6)
Art History PhD
Art History PhD
Dance PhD
Dance PhD
Documentary Arts and Visual Research PhD
Documentary Arts and Visual Research PhD
Education PhD
Education PhD
English PhD
English PhD
History PhD
History PhD
Music Education PhD
Music PhD
Music Therapy PhD
Performance DMA
Philosophy PhD
Religion PhD
Spanish PhD
Business and Management (6)
Applied Economics PhD
Applied Economics PhD
Business Administration PhD
Business Administration PhD
Executive DBA
Executive DBA
Engineering and Technology (6)
Bioengineering PhD
Bioengineering PhD
Civil Engineering PhD
Civil Engineering PhD
Computer and Information Science PhD
Computer and Information Science PhD
Electrical Engineering PhD
Electrical Engineering PhD
Environmental Engineering PhD
Environmental Engineering PhD
Mechanical Engineering PhD
Mechanical Engineering PhD
Life Sciences and Medicine (6)
Advanced Education in General Dentistry Dentistry Certificate
Advanced Education in General Dentistry Dentistry Certificate
Bioinformatics PhD
Bioinformatics PhD
Biology PhD
Biology PhD
Biomedical Sciences PhD
Biomedical Sciences PhD
Decision Neuroscience PhD
Decision Neuroscience PhD
Dental Public Health Certificate (Graduate)
Dental Public Health Certificate (Graduate)
Dentistry (Advanced Standing Program for Internationally Trained Dentists) DMD
Dentistry DMD
Doctor of Athletic Training DAT
Endodontics Dentistry Certificate
Medicine MD
Nursing DNP
Oral and Maxillofacial Surgery Certificate (Graduate)
Periodontics Certificate (Graduate)
Pharmaceutical Sciences PhD
Pharmacy PharmD
Podiatric Medicine DPM
Prosthodontics Certificate (Graduate)
Psychology PhD
Natural Sciences (6)
Chemistry PhD
Chemistry PhD
Geography PhD
Geography PhD
Geoscience PhD
Geoscience PhD
Mathematics PhD
Mathematics PhD
Physics PhD
Physics PhD
Social Sciences and Management (6)
Africology and African American Studies PhD
Africology and African American Studies PhD
Communication Sciences and Disorders PhD
Communication Sciences and Disorders PhD
Criminal Justice PhD
Criminal Justice PhD
Educational Leadership EdD
Educational Leadership EdD
Epidemiology PhD
Epidemiology PhD
Health Informatics PhD
Health Informatics PhD
Health Policy and Health Services Research PhD
Higher Education EdD
Juris Doctor (J.D.)
Law SJD
Media and Communication PhD
Occupational Therapy OTD
Occupational Therapy Transitional Program OTD
Physical Therapy DPT
Policy and Organizational Studies PhD
Political Science PhD
School Psychology PhD
Social and Behavioral Sciences PhD
Sociology PhD
Statistics PhD