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The MSc in Drug Regulatory Affairs is an international programme focusing on the regulation of medicinal, biological and biotechnological products, as well as on the regulation of medical devices and herbal medicinal products.
The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, employees in healthcare and biotech companies, regulatory bodies, but also individuals who aspire for a career in the aforementioned industries. Candidates will gain comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs, biological and biotechnological products. This will qualify them as specialists in the entire process of drug registration from the initial stages of discovery to the final approval and post marketing surveillance. Graduates of the programme will be qualified to advise and get involved in professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration.
The programme also offers the opportunity for ongoing professional development of individuals already employed in the field at a junior level.
Programme Objectives
The objectives of the program are to get a thorough understanding of the many aspects of the regulatory structure and process, and be able to apply regulations correctly and effectively. In order to achieve these objectives, topics that will be taught include:
The principles of drug discovery and drug development
EU regulation and legislation
EU regulatory procedures
Marketing authorization applications
Pharmaceutical regulatory affairs aspects of Pharmaceutical quality
Pharmaceutical regulatory affairs aspects of Non-clinical development
Pharmaceutical regulatory affairs aspects of Clinical development
Pharmaceutical regulatory affairs aspects of Quality management
The future directions in global pharmaceutical and health economics and their implications for product development and evaluation
The documentation and data requirements for submission to regulatory authorities covering the diverse stages of the product development process.
Implementation and evaluation of improvements in performance drawing on innovative or best practice
Regulatory, project management and business planning strategies of relevance to the approval process of regulated products
Drug Safety / Pharmacovigilance and Role of Pharmacoepidemiology
Regulatory Affairs οf medical devices
Market pricing and reimbursement
The legal directives and ethical considerations for development, commercialization and marketing of products for clinical use.
Career Prospects
Regulatory professionals are employed in industry, government or independent regulatory bodies, consulting companies, or academia, and are involved in the regulation of a wide range of products, including:
Human Medicinal Products
Biopharmaceuticals
Medical Devices
Veterinary Products
Herbal Medicinal Products
They ensure products adhere to all regulatory requirements throughout all phases of product
development and market life.
Our graduates can assume regulatory positions such as:
Regulatory affairs associate/specialist
Regulatory affairs consultant
Regulatory affairs manager
Compliance specialist/officer
Clinical research associate
Clinical trial manager
Medical writer
Access to Further Studies
Graduates of the programme can be accepted into Third Cycle degrees (Doctoral Degree)
Note: The program offers a thesis and non thesis option. In the non thesis option, two elective courses must be completed instead of the thesis. In some countries and/or institutions, a master without a thesis may not be recognized. If you choose to pursue the non thesis option it is advised that you check with your country’s regulations for the acceptability/recognition of a master without a thesis. For further clarifications you can contact the program coordinator.
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
MSc
Study Level
Masters
Study Mode
Online
The MSc in Drug Regulatory Affairs is an international programme focusing on the regulation of medicinal, biological and biotechnological products, as well as on the regulation of medical devices and herbal medicinal products.
The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, employees in healthcare and biotech companies, regulatory bodies, but also individuals who aspire for a career in the aforementioned industries. Candidates will gain comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs, biological and biotechnological products. This will qualify them as specialists in the entire process of drug registration from the initial stages of discovery to the final approval and post marketing surveillance. Graduates of the programme will be qualified to advise and get involved in professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration.
The programme also offers the opportunity for ongoing professional development of individuals already employed in the field at a junior level.
Programme Objectives
The objectives of the program are to get a thorough understanding of the many aspects of the regulatory structure and process, and be able to apply regulations correctly and effectively. In order to achieve these objectives, topics that will be taught include:
The principles of drug discovery and drug development
EU regulation and legislation
EU regulatory procedures
Marketing authorization applications
Pharmaceutical regulatory affairs aspects of Pharmaceutical quality
Pharmaceutical regulatory affairs aspects of Non-clinical development
Pharmaceutical regulatory affairs aspects of Clinical development
Pharmaceutical regulatory affairs aspects of Quality management
The future directions in global pharmaceutical and health economics and their implications for product development and evaluation
The documentation and data requirements for submission to regulatory authorities covering the diverse stages of the product development process.
Implementation and evaluation of improvements in performance drawing on innovative or best practice
Regulatory, project management and business planning strategies of relevance to the approval process of regulated products
Drug Safety / Pharmacovigilance and Role of Pharmacoepidemiology
Regulatory Affairs οf medical devices
Market pricing and reimbursement
The legal directives and ethical considerations for development, commercialization and marketing of products for clinical use.
Career Prospects
Regulatory professionals are employed in industry, government or independent regulatory bodies, consulting companies, or academia, and are involved in the regulation of a wide range of products, including:
Human Medicinal Products
Biopharmaceuticals
Medical Devices
Veterinary Products
Herbal Medicinal Products
They ensure products adhere to all regulatory requirements throughout all phases of product
development and market life.
Our graduates can assume regulatory positions such as:
Regulatory affairs associate/specialist
Regulatory affairs consultant
Regulatory affairs manager
Compliance specialist/officer
Clinical research associate
Clinical trial manager
Medical writer
Access to Further Studies
Graduates of the programme can be accepted into Third Cycle degrees (Doctoral Degree)
Note: The program offers a thesis and non thesis option. In the non thesis option, two elective courses must be completed instead of the thesis. In some countries and/or institutions, a master without a thesis may not be recognized. If you choose to pursue the non thesis option it is advised that you check with your country’s regulations for the acceptability/recognition of a master without a thesis. For further clarifications you can contact the program coordinator.
Admission Requirements
6.5+
79+
A Bachelor’s degree related to Pharmacy, Chemistry, Medicine, Veterinary, Biology or related Fields (together with a transcript) from an accredited institution of higher education.
Curriculum Vitae
Short statement (approximately one page) of personal goals and professional interests.
Knowledge of English language.
Two recommendation letters (one preferably from University Professor).
Other documents that might support the application (e.g. articles, books, awards).
Documentation on previous working experience in the Pharmaceutical Industry (if applicable).
The admissions process also includes an interview with the candidate.
English Language Proficiency
Students satisfy the English requirements if their first degree was taught in English. Otherwise, they would need to present a minimum TOEFL score 550 and above, or Computer-based TOEFL score of 213 and above, or Internet-based TOEFL (iBT) score 79-80 and above, or GCSE (or GCE) English Language “O” Level of “C” or above or IELTS of 6.5 and above or Cambridge Exams (First Certificate with Grade B and above, as well as Proficiency with Grade C and above or a score placement at the ENGL-100 level of the University English Placement Test. The University offers English courses at various levels to help students reach the required standard for admission to a graduate program.
1 Month
Feb
Sep
Candidates are required to submit references or letter(s) of recommendation for acceptance
Domestic
12,060 EUR
International
12,060 EUR
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:
Drug Regulatory Affairs (MSc, 3 Semesters) - E-Learning/Distance Learning (Online)
UNIC NICOSIA, Nicosia, Cyprus
1 monthsProgramme duration
12,060 EURTuition Fee/year
Pharmacy and PharmacologyMain Subject Area
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
MSc
Study Level
Masters
Study Mode
Online
The MSc in Drug Regulatory Affairs is an international programme focusing on the regulation of medicinal, biological and biotechnological products, as well as on the regulation of medical devices and herbal medicinal products.
The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, employees in healthcare and biotech companies, regulatory bodies, but also individuals who aspire for a career in the aforementioned industries. Candidates will gain comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs, biological and biotechnological products. This will qualify them as specialists in the entire process of drug registration from the initial stages of discovery to the final approval and post marketing surveillance. Graduates of the programme will be qualified to advise and get involved in professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration.
The programme also offers the opportunity for ongoing professional development of individuals already employed in the field at a junior level.
Programme Objectives
The objectives of the program are to get a thorough understanding of the many aspects of the regulatory structure and process, and be able to apply regulations correctly and effectively. In order to achieve these objectives, topics that will be taught include:
Career Prospects
Regulatory professionals are employed in industry, government or independent regulatory bodies, consulting companies, or academia, and are involved in the regulation of a wide range of products, including:
They ensure products adhere to all regulatory requirements throughout all phases of product
development and market life.
Our graduates can assume regulatory positions such as:
Access to Further Studies
Graduates of the programme can be accepted into Third Cycle degrees (Doctoral Degree)
Note: The program offers a thesis and non thesis option. In the non thesis option, two elective courses must be completed instead of the thesis. In some countries and/or institutions, a master without a thesis may not be recognized. If you choose to pursue the non thesis option it is advised that you check with your country’s regulations for the acceptability/recognition of a master without a thesis. For further clarifications you can contact the program coordinator.
Programme overview
Main Subject
Pharmacy and Pharmacology
Degree
MSc
Study Level
Masters
Study Mode
Online
The MSc in Drug Regulatory Affairs is an international programme focusing on the regulation of medicinal, biological and biotechnological products, as well as on the regulation of medical devices and herbal medicinal products.
The programme targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, employees in healthcare and biotech companies, regulatory bodies, but also individuals who aspire for a career in the aforementioned industries. Candidates will gain comprehensive and detailed knowledge of the procedures related to the application, registration and approval of drugs, biological and biotechnological products. This will qualify them as specialists in the entire process of drug registration from the initial stages of discovery to the final approval and post marketing surveillance. Graduates of the programme will be qualified to advise and get involved in professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration.
The programme also offers the opportunity for ongoing professional development of individuals already employed in the field at a junior level.
Programme Objectives
The objectives of the program are to get a thorough understanding of the many aspects of the regulatory structure and process, and be able to apply regulations correctly and effectively. In order to achieve these objectives, topics that will be taught include:
Career Prospects
Regulatory professionals are employed in industry, government or independent regulatory bodies, consulting companies, or academia, and are involved in the regulation of a wide range of products, including:
They ensure products adhere to all regulatory requirements throughout all phases of product
development and market life.
Our graduates can assume regulatory positions such as:
Access to Further Studies
Graduates of the programme can be accepted into Third Cycle degrees (Doctoral Degree)
Note: The program offers a thesis and non thesis option. In the non thesis option, two elective courses must be completed instead of the thesis. In some countries and/or institutions, a master without a thesis may not be recognized. If you choose to pursue the non thesis option it is advised that you check with your country’s regulations for the acceptability/recognition of a master without a thesis. For further clarifications you can contact the program coordinator.
Admission Requirements
The admissions process also includes an interview with the candidate.
English Language Proficiency
Students satisfy the English requirements if their first degree was taught in English. Otherwise, they would need to present a minimum TOEFL score 550 and above, or Computer-based TOEFL score of 213 and above, or Internet-based TOEFL (iBT) score 79-80 and above, or GCSE (or GCE) English Language “O” Level of “C” or above or IELTS of 6.5 and above or Cambridge Exams (First Certificate with Grade B and above, as well as Proficiency with Grade C and above or a score placement at the ENGL-100 level of the University English Placement Test. The University offers English courses at various levels to help students reach the required standard for admission to a graduate program.
Domestic
International
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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Exercise Science and Physical Education (PhD, 3 Years)
Exercise Science and Physical Education (PhD, 3 Years)
Human Rights, Society, and Multi-Level Governance (PhD, 3 Years or 6 Semesters) – Joint Degree with the University of Padova, the University of Zagreb, the University of Western Sydney, and Panteion University, Athens
Human Rights, Society, and Multi-Level Governance (PhD, 3 Years or 6 Semesters) – Joint Degree with the University of Padova, the University of Zagreb, the University of Western Sydney, and Panteion University, Athens
International Relations and European Studies (PhD, 3 Years)
International Relations and European Studies (PhD, 3 Years)
Law (PhD, 3 Years)
Law (PhD, 3 Years)
Media and Communications (PhD, 3 Years)
Media and Communications (PhD, 3 Years)
Public Administration (PhD, 3 Years)
TESOL (PhD, 3 Years)