Master of Science in Drug Regulatory Affairs

Program Overview

This distance learning Master's program in Drug Regulatory Affairs provides a comprehensive understanding of regulations governing medicinal products, medical devices, and herbal medicinal products. Participants gain expertise in drug registration procedures, from discovery to post-marketing surveillance, preparing them for careers in the pharmaceutical industry, healthcare, and regulatory bodies. The program consists of 3 semesters, with 90 ECTS credits required for graduation, and is taught by experienced faculty from the University of Nicosia, Cyprus.

Program Outline

Drug Regulatory Affairs (MSc, 3 Semesters) – Distance Learning

Degree Overview:

This Master's program delves into the regulations governing medicinal products, biological and biotechnological products, medical devices, and herbal medicinal products. It caters to professionals in the pharmaceutical industry, healthcare and biotech companies, and regulatory bodies. Participants gain in-depth knowledge of drug registration procedures, enabling them to specialize in the entire process, from discovery to post-marketing surveillance.

Objectives:

• Develop a comprehensive understanding of the regulatory process.
• Apply regulations effectively to navigate the various stages of drug development and approval.
• Acquire knowledge in critical areas like:
• Drug discovery and development principles
• EU regulations and legislation
• EU regulatory procedures
• Marketing authorization applications
• Pharmaceutical regulatory affairs aspects of:
• Pharmaceutical quality
• Non-clinical development
• Clinical development
• Quality management
• The future directions in global pharmaceutical and health economics
• Documentation and data requirements for regulatory submissions
• Implementation and evaluation of performance improvements
• Regulatory, project management, and business planning strategies for regulated product approval
• Drug Safety / Pharmacovigilance and the Role of Pharmacoepidemiology
• Regulatory Affairs of herbal medicinal products and medical devices
• Legal and ethical considerations for product development, commercialization, and marketing

Outline:

Structure:

• The program consists of 3 semesters, delivered through distance learning.
• Students complete 90 ECTS credits to fulfill program requirements.
• A minimum cumulative grade point average (CPA) of 2.0 is required for graduation.

Courses:

Section A: Compulsory Courses (67.5 ECTS Credits)

• PHAR-601: Drug Discovery and Development
• PHAR-602: The DRA Professional
• PHAR-603: EU Regulatory Affairs System
• PHAR-604: Pharmaceutical Industry Ethics
• PHAR-605: Regulatory Strategy and Marketing Applications for new Drugs
• PHAR-606: Clinical Trials: Issues in Design, Conducts and Evaluation
• PHAR-607: International Regulations (ICH & FDA)
• PHAR-608: Preclinical and Clinical Development and Documentation
• PHAR-610: Pharmacovigilance and Pharmacoepidemiology

Section B: Elective Courses (7.5 ECTS Credits) 7.5 ECTS Credits)

• PHAR-609: Product's Life Cycle Activities
• PHAR-611: Regulation of Herbal Medicinal Products
• PHAR-612: Regulation of Medical Devices
• PHAR-613: Health Technology Assessment

Section C: Postgraduate Assignment (15 ECTS Credits)

• PHAR-614: Post Graduate Assignment

Schedule:

• Semester 1: PHAR-601, PHAR-602, PHAR-603, PHAR-604
• Semester 2: PHAR-605, PHAR-606, PHAR-607, PHAR-608

Assessment:

Assessment Methods:

• Comprehensive final exam
• Continuous assessment (weekly interactive activities, projects, online forum participation)

Assessment Criteria:

• Letter grades are calculated based on the weight and actual marks obtained in the final exam and continuous assessment components.
• A minimum cumulative grade point average (CPA) of 2.0 is required for graduation.

Teaching:

Teaching Methods:

• Distance learning delivery
• Interactive activities
• Online forums
• Projects

Faculty:

• Dr Eleftheria Galatou (Assistant Professor, School of Life and Health Sciences, Department of Health Sciences)
• Dr Elena Mourelatou (Assistant Professor, School of Life and Health Sciences, Department of Health Sciences)
• Dr Christos Papaneophytou (Associate Dean, Associate Professor, Programme Coordinator, School of Life and Health Sciences, Department of Life Sciences)
• Dr Christos Petrou (Head of Department, Associate Professor, School of Life and Health Sciences, Department of Health Sciences)
• Dr Ioannis Sarigiannis (Associate Professor, School of Life and Health Sciences, Department of Health Sciences)
• Dr Lefteris Zacharia (Associate Professor, School of Life and Health Sciences, Department of Health Sciences)

Adjunct Faculty:

• Dr Georgios Aislaitner
• Dr Gianpiero Calabrese
• Dr Christiana Kitromilidou
• Dr Thelma Koullourou
• Dr Panayiotis Petrou
• Ms Maria Prapopoulou
• Dr Anastasia Sideri
• Dr Dimitrios Zampatis

Careers:

Potential Career Paths:

• Regulatory Affairs Specialist
• Clinical Research Associate
• Medical Writer
• Quality Assurance Specialist
• Project Manager (Pharmaceutical Industry)
• Regulatory Affairs Manager
• Consultant (Pharmaceutical Industry)

Career Opportunities:

• Pharmaceutical companies
• Biotech companies
• Regulatory agencies
• Contract research organizations (CROs)
• Medical device companies
• Healthcare organizations

Other:

• Admission Requirements:
• Completed application form
• Curriculum Vitae
• Bachelor's degree in a relevant field from an accredited institution
• Short statement of personal goals and professional interests
• Evidence of English language proficiency
• Two recommendation letters
• Additional supporting documents (articles, awards, etc.)
• Documentation of previous work experience in the Pharmaceutical Industry (if applicable)
• Application Process:
• Complete the online application form
• Submit required documents
• Attend an interview (if required)
• Duration: 3 semesters
• Qualification Awarded: Master of Science in Drug Regulatory Affairs
• Language of Instruction: English
• Mode of Study: Distance Learning
• Location: University of Nicosia, Cyprus
• Contact Information:
• Email: admissions@unic.ac.cy
• Phone: +357 22 841 500
• Website: https://www.unic.ac.cy/programmes/drug-regulatory-affairs-msc-3-semesters-distance-learning/