MSc in Drug Regulatory Affairs – Distance Learning

General

Program Description

  • Duration: 1.5 Years (3 Semesters)
  • Qualification Awarded: Master of Science in Drug Regulatory Affairs
  • Level of Qualification: Master Degree (2nd Cycle)
  • Language of Instruction: English
  • Mode of Study: Distance Learning
  • Minimum ECTS Credits: 90

Overview

The programme is an international master’s program on the regulation of medicinal products, biological and biotechnological products as well as on the regulation of other health care products i.e medical devices and herbal medicinal products.

The program targets individuals involved in the regulatory and legislative areas of the pharmaceutical industry, as well as employees in healthcare and biotech companies or in regulatory bodies. Candidates will gain a comprehensive and detailed knowledge of the procedures related to the application, registration, and approval of drugs and biological and biotechnological products that will qualify them to specialize in the entire process of drug registration from the initial stages of discovery to final approval and to the post-marketing surveillance. Programme participants will thus be qualified to advise and involve professional groups in the development process surrounding the regulatory and statutory requirements governing drug registration, potentially shortening the length of time it takes for companies to obtain marketing approval and managing the drug on the international market. Also, the programme offers the opportunity for continuing professional development of persons already employed in this field at the junior level.

  • Skilled Regulatory Affairs professionals are in high demand.
  • The first MSc in Drug Regulatory Affairs in Southern Europe and the Middle East.
  • Ideal for both working professionals and new graduates.
  • Fully online Master’s Degree from the first University in the EU to receive a 5-star rating for Online/Distance Learning.
  • Focused on global outreach through engagement with regulations in the EU, US and emerging markets.
  • Flexible learning tailored to your needs and designed to meet the current demands of the pharmaceutical industry.

Programme Objectives

The objectives of the programme are to get a thorough understanding of the many aspects of the regulatory 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 herbal medicinal products and medical devices
  • The legal directives and ethical considerations for the development, commercialisation and marketing of products for clinical use.

Admission

  • Completed application form.
  • Curriculum Vitae.
  • A Bachelor’s degree (accompanied by a transcript) in a field related to Pharmacy, Chemistry, Medicine, Veterinary, Biology from an accredited institution of higher education.
  • A short statement (approximately one page) of personal goals and professional interests.
  • Evidence of knowledge of the English language (I.E.L.T.S band score ≥ 6.5 or equivalent).
  • Two recommendation letters (one preferably from a 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 includes an interview with the candidate.

Assessment

Course assessment usually comprises of a comprehensive final exam and continuous assessment. Continuous assessment can include amongst others, mid-terms, projects etc.

Letter grades are calculated based on the weight of the final exam and the continuous assessment and the actual numerical marks obtained in these two assessment components. Based on the course grades the student’s semester grade point average (GPA) and cumulative point average (CPA) are calculated.

Graduation

The student must complete 90 ECTS and all programme requirements.

A minimum cumulative grade point average (CPA) of 2.0 is required. Thus, although a ‘D-‘ is a PASS grade, in order to achieve a CPA of 2.0 an average grade of ‘C’ is required.

Learning Outcomes

Upon successful completion of this program, the students should be able to:

  1. Critically evaluate the requirements for obtaining Marketing Authorization for medicinal products and medical devices in the EU, US and Emerging Markets.
  2. Independently initiate and carry out proper actions between regulatory authorities and the marketing application authorization applicant/holder.
  3. Critically examine and evaluate scientific data and conclusions intended for regulatory review.
  4. Appraise the regulatory documentation and systems.
  5. Adapt to changing guidelines and regulatory systems.
  6. Interpret and critically analyze complex regulatory requirements, legal and ethical obligations and construct and communicate regulatory strategy to colleagues.
  7. Operate as an effective team member or leader in interdisciplinary teams or multi-agency teams.
  8. Critically appraise of research/evidence in the field of pre-clinical and clinical development planning and submission.
  9. Design and conduct of regulatory training sessions for leaders and employees.
  10. Appraise the process of evaluating risks and assess the risk/benefit ratio.
  11. Analyze Type I and Type II variations.
  12. Analyze the concept of pharmacoepidemiology and how it affects drug approval and postmarketing activities.
  13. Summarize the basic drug design & development process.
  14. Critically examine the concept of signalling in Pharmacovigilance.
  15. Critically evaluate regulations in several countries/regions.

Academic Path

Section: A – Compulsory Courses

Minimum ECTS Credits: 67.5 Maximum ECTS Credits: 67.5

Course ID Course Title ECTS Credits
PHAR-601 Drug Discovery and Development 7.5
PHAR-602 The DRA Professional 7.5
PHAR-603 EU Regulatory Affairs System 7.5
PHAR-604 Pharmaceutical Industry Ethics 7.5
PHAR-605 Regulatory Strategy and Marketing Applications for New Drugs 7.5
PHAR-606 Clinical Trials: Issues in Design, Conducts and Evaluation 7.5
PHAR-607 International Regulations (ICH & FDA) 7.5
PHAR-608 Preclinical and Clinical Development and Documentation 7.5
PHAR-610 Health Technology Assessment 7.5

Section: B – Elective Courses

Min. ECTS Credits: 7.5 Max. ECTS Credits: 7.5

Course ID Course Title ECTS Credits
PHAR-609 Product’s Life Cycle Activities 7.5
PHAR-611 Regulation of Herbal Medicinal Products 7.5
PHAR-612 Regulation of Medical Devices 7.5
PHAR-613 Pharmaceutical Industry Ethics 7.5

Section: C – Postgraduate Assignment

Minimum ECTS Credits: 15 Maximum ECTS Credits: 15

Course ID Course Title ECTS Credits
PHAR-614 Post Graduate Assignment 15

Semester Breakdown

Semester 1

Course ID Course Title ECTS Credits
PHAR-601 Drug Discovery and Development 7.5
PHAR-602 The DRA Professional 7.5
PHAR-603 EU Regulatory Affairs System 7.5
PHAR-604 Pharmaceutical Industry Ethics 7.5

Semester 2

Course ID Course Title ECTS Credits
PHAR-605 Regulatory Strategy and Marketing Applications for New Drugs 7.5
PHAR-606 Clinical Trials: Issues in Design, Conducts and Evaluation 7.5
PHAR-607 International Regulations (ICH & FDA) 7.5
PHAR-608 Preclinical and Clinical Development and Documentation 7.5

Semester 3

Course ID Course Title ECTS Credits
PHAR-609 Product’s Life Cycle Activities 7.5
PHAR-610 Pharmacovigilance and Pharmacoepidemiology 7.5
PHAR-614 Post Graduate Assignment 15

The above semester breakdown is an indicative one. A few of the courses are electives and can be substituted by others. Students may contact their academic advisor and consult their academic pathway found on this website under “Schools & Programmes”.

Featured Faculty

“Regulatory affairs are integral to the registration and approval of pharmaceutical products in an increasingly demanding legislative and competitive environment. The Drug Regulatory Affairs programme from the University of Nicosia will provide the participants with a comprehensive overview of the complex regulatory landscape across all phases of the drug development process. The programme graduates will be able to contribute to the registration of safe and effective medicinal products in compliance with stringent regulatory requirements”.

Anastasia Sideri, PhD, Medical Advisor, Medical Affairs, Zeincro Hellas SA

“Regulatory Affairs (RA) professionals play a critical role in the pharmaceutical industry since they are the ones responsible for a healthcare product’s lifecycle, providing strategic and operational direction and support to work within the regulations and guidelines to expedite the development and delivery of safe and effective products worldwide. The demand for RA professionals is evident across the pharma industry, consultancy companies, regulatory agencies, and clinical research organisations. The postgraduate course at the University of Nicosia offers high-quality education for people who would like to follow this career pathway. In addition, the programme is structured in such a way that it offers those already employed in this field at a junior level the opportunity for continuing professional development”.

Christiana Kitromilidou, Regulatory & Pharmacovigilance Manager, PHADISCO LTD

Last updated September 2019

About the School

UNIC is the largest university in Cyprus, with over 12,000+ students, from over 70 countries across the globe, coming together in an innovative and transformative learning space.

UNIC is the largest university in Cyprus, with over 12,000+ students, from over 70 countries across the globe, coming together in an innovative and transformative learning space. Read less
Nicosia , Athens + 1 More Less