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The Certificate in Biologics and Biosimilars: Regulatory Aspects in the School of Pharmacy at Temple University helps students gain the knowledge and credentials needed to work in the U.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program.
The Biologics and Biosimilars: Regulatory Aspects Certificate explores the following topics.
Regulatory issues that are unique to biologics and biosimilar drug manufacturers
The current regulatory and technical/scientific issues involved in developing biological products in major International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions
The clinical, manufacturing, regulatory and strategic issues that challenge the path to global commercialization of a biological product
The principles that guide the development of biosimilar drugs
How biosimilar development differs from innovator drug development
How biologics and biosimilars differ from chemically synthesized drugs
The analytical methods used to characterize biologics and how analytical testing differs from small molecule testing
The quality by design principles related to the development, manufacturing and testing of biologics
This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. Through the courses, students are exposed to key trends and controversies facing the biologics and biosimilar industry.
The Certificate in Biologics and Biosimilars: Regulatory Aspects enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally.
Executive recruiters often call Temple’s RA and QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. The Certificate in Biologics and Biosimilars: Regulatory Aspects provides students with credentials from Temple’s well-respected RA and QA graduate program, giving them a solid grounding in key U.S. and global regulations that affect biologic and biosimilar products. The certificate is open to both MS in RA and QA applicants and MS graduates, who can expand their career opportunities with this new credential.
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
Other
Study Level
Masters
Study Mode
On Campus
The Certificate in Biologics and Biosimilars: Regulatory Aspects in the School of Pharmacy at Temple University helps students gain the knowledge and credentials needed to work in the U.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program.
The Biologics and Biosimilars: Regulatory Aspects Certificate explores the following topics.
Regulatory issues that are unique to biologics and biosimilar drug manufacturers
The current regulatory and technical/scientific issues involved in developing biological products in major International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions
The clinical, manufacturing, regulatory and strategic issues that challenge the path to global commercialization of a biological product
The principles that guide the development of biosimilar drugs
How biosimilar development differs from innovator drug development
How biologics and biosimilars differ from chemically synthesized drugs
The analytical methods used to characterize biologics and how analytical testing differs from small molecule testing
The quality by design principles related to the development, manufacturing and testing of biologics
This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. Through the courses, students are exposed to key trends and controversies facing the biologics and biosimilar industry.
The Certificate in Biologics and Biosimilars: Regulatory Aspects enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally.
Executive recruiters often call Temple’s RA and QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. The Certificate in Biologics and Biosimilars: Regulatory Aspects provides students with credentials from Temple’s well-respected RA and QA graduate program, giving them a solid grounding in key U.S. and global regulations that affect biologic and biosimilar products. The certificate is open to both MS in RA and QA applicants and MS graduates, who can expand their career opportunities with this new credential.
Admission Requirements
Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).
Only one certificate program may be completed before students receive the MS.
The certificate must be completed within four years.
Students must apply for the certificate no more than one year after completing the course requirements.
Students interested in pursuing the RA and QA MS degree may apply all credits earned in the certificate towards their graduate degree, provided they formally apply for admission to the MS program and are accepted by Temple University’s graduate school.
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biology, Chemistry, Engineering, Pharmacy, Physics or related field.
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:
Biologics and Biosimilars Regulatory Aspects 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 Certificate in Biologics and Biosimilars: Regulatory Aspects in the School of Pharmacy at Temple University helps students gain the knowledge and credentials needed to work in the U.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program.
The Biologics and Biosimilars: Regulatory Aspects Certificate explores the following topics.
This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. Through the courses, students are exposed to key trends and controversies facing the biologics and biosimilar industry.
The Certificate in Biologics and Biosimilars: Regulatory Aspects enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally.
Executive recruiters often call Temple’s RA and QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. The Certificate in Biologics and Biosimilars: Regulatory Aspects provides students with credentials from Temple’s well-respected RA and QA graduate program, giving them a solid grounding in key U.S. and global regulations that affect biologic and biosimilar products. The certificate is open to both MS in RA and QA applicants and MS graduates, who can expand their career opportunities with this new credential.
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
Other
Study Level
Masters
Study Mode
On Campus
The Certificate in Biologics and Biosimilars: Regulatory Aspects in the School of Pharmacy at Temple University helps students gain the knowledge and credentials needed to work in the U.S and global regulations governing biologics and biosimilar drugs. This certificate is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program.
The Biologics and Biosimilars: Regulatory Aspects Certificate explores the following topics.
This specialized curriculum delves into the requirements of major ICH markets for biologics and biosimilar products. The certificate builds a strong foundation in the biologics and biosimilar regulatory landscape. Through the courses, students are exposed to key trends and controversies facing the biologics and biosimilar industry.
The Certificate in Biologics and Biosimilars: Regulatory Aspects enables students to sharpen their knowledge of this industry niche without committing to the entire master’s degree. This certificate provides the tools and information to understand how biologics and biosimilars are regulated nationally, regionally and globally.
Executive recruiters often call Temple’s RA and QA office seeking candidates with demonstrated knowledge of the regulations governing this discipline. The Certificate in Biologics and Biosimilars: Regulatory Aspects provides students with credentials from Temple’s well-respected RA and QA graduate program, giving them a solid grounding in key U.S. and global regulations that affect biologic and biosimilar products. The certificate is open to both MS in RA and QA applicants and MS graduates, who can expand their career opportunities with this new credential.
Admission Requirements
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biology, Chemistry, Engineering, Pharmacy, Physics or related field.
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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Geography MA
Geology MS
Geology MS
Geospatial Data Science Graduate Certificate
Geospatial Data Science Graduate Certificate
Geospatial Data Science PSM
Geospatial Data Science PSM
Graduate Certificate in Mathematics for Teaching
Graduate Certificate in Mathematics for Teaching
Master of Science in Actuarial Science
Master of Science in Actuarial Science
Mathematics MS
Mathematics MS
Nutrition MPH
Nutrition MPH
Physics MS
Physics MS
Sustainability PSM
Sustainability PSM
Social Sciences and Management (6)
Accomplished Teaching MSEd
Accomplished Teaching MSEd
Adult Learning, Training and Organizational Development MEd
Adult Learning, Training and Organizational Development MEd
Africology and African American Studies MA
Africology and African American Studies MA
American and International Law LLM
American and International Law LLM
Applied Behavior Analysis MSEd
Applied Behavior Analysis MSEd
Applied Behavioral Analysis Graduate Certificate
Applied Behavioral Analysis Graduate Certificate
Applied Clinical Research Graduate certificate
Applied Clinical Research Graduate certificate
Applied Research and Evaluation PSM
Applied Research and Evaluation PSM
Art Education MEd
Art Education MEd
Asian Law LLM
Asian Law LLM
Autism Endorsement Graduate Certificate
Autism Endorsement Graduate Certificate
Business Law Juris Doctor Certificate
Business Law Juris Doctor Certificate
Career and Technical Education MEd
Career and Technical Education MEd
Career and Technical Education MSEd
Career and Technical Education MSEd
College Access and Success Graduate Certificate
College Access and Success Graduate Certificate
Communication Management MS
Communication Management MS
Communication for Development and Social Change MS
Communication for Development and Social Change MS
Computational Data Science MS
Computational Data Science MS
Conflict Management and Dispute Resolution Graduate Certificate
Conflict Management and Dispute Resolution Graduate Certificate
Conflict Process Graduate Certificate
Conflict Process Graduate Certificate
Counseling Psychology MEd
Counseling Psychology MEd
Criminal Justice MA
Criminal Justice MA
Cultural Analytics Graduate Certificate
Cultural Analytics Graduate Certificate
Data Driven Decision Making Graduate Certificate
Data Driven Decision Making Graduate Certificate
Disability Studies Graduate Certificate
Disability Studies Graduate Certificate
Diversity Leadership in Higher Education Graduate Certificate
Diversity Leadership in Higher Education Graduate Certificate
Documentary Arts and Ethnographic Research Graduate Certificate
Documentary Arts and Ethnographic Research Graduate Certificate
Early Childhood Education MEd
Early Childhood Education MEd
Early and Elementary Education with Special Education MEd
Early and Elementary Education with Special Education MEd
Educational and Organizational Leadership MEd
Educational and Organizational Leadership MEd
English Language Teaching Graduate Certificate
English Language Teaching Graduate Certificate
English as a Second Language Graduate Certificate
English as a Second Language Graduate Certificate
Environmental Health MPH
Environmental Health MPH
Epidemiology MPH
Epidemiology MPH
Gender, Sexuality and Women’s Studies Graduate Certificate
Gender, Sexuality and Women’s Studies Graduate Certificate
Global Health Graduate Certificate
Global Health Graduate Certificate
Health Informatics Graduate Certificate
Health Informatics Graduate Certificate
Health Policy and Management MPH
Health Policy and Management MPH
Higher Education MEd
Higher Education MEd
Institutional Effectiveness Graduate Certificate
Institutional Effectiveness Graduate Certificate
Instructional Learning Technology Graduate Certificate
Instructional Learning Technology Graduate Certificate
Interdisciplinary Health Communication Graduate Certificate
Interdisciplinary Health Communication Graduate Certificate
International Business and Compliance Graduate Certificate
International Business and Compliance Graduate Certificate
Journalism MJ
Journalism MJ
LL.M. and J.D./LL.M. in Transnational Law
LL.M. and J.D./LL.M. in Transnational Law
LL.M. in Trial Advocacy
LL.M. in Trial Advocacy
Master of Science in Human Resource Management
Master of Science in Human Resource Management
Master of Science in Sport Business
Master of Science in Sport Business
Media Studies and Production MA
Media Studies and Production MA
Middle Grades Education MEd
Middle Grades Education MEd
Neuroscience Graduate Certificate
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 Program MBA
Executive Program MBA
Full-Time MBA (4)
Business Administration MBA
Business Administration 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 DBA
Business Administration DBA
Business Administration PhD
Business Administration PhD
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