Drug Regulatory Affairs (MSc, 3 Semesters) - E-Learning/Distance Learning (Online) 1 months Postgraduate Programme By University of Nicosia |TopUniversities
Programme Duration

1 monthsProgramme duration

Tuitionfee

12,060 EURTuition Fee/year

Main Subject Area

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:


  • 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

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