• Application Deadline
  • 18 months
    Duration
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Overview

The Drug Regulatory Affairs (Distance Learning) programme from University of Nicosia 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 a 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.

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 development, commercialisation and marketing of products for clinical use.

Programme Structure

Courses include:

  • Drug Discovery and Development 
  • The DRA Professional 
  • EIJ Regulatory Affairs System 
  • Pharmaceutical Industry Ethics 
  • Regulatory Strategy and Marketing Applications for new Drugs 
  • Clinical Trials: Issues in Design, Conducts and Evaluation 
  • International Regulations (ICH & FDA) 
  • Preclinical and Clinical Development end Documentation 
  • Health Technology Assessment 

Detailed Programme Facts

  • Programme intensity Part-time
    • Average part-time duration 18 months
  • Credits
    90 ECTS
  • Languages
    • English
  • Delivery mode
    Online
  • More information Go to the programme website

English Language Requirements

You need the following IELTS score:

  • Minimum required score:

    6.5

    The IELTS – or the International English Language Test System – tests your English-language abilities (writing, listening, speaking, and reading) on a scale of 1.00–9.00. The minimum IELTS score requirement refers to which Overall Band Score you received, which is your combined average score. Read more about IELTS.

    Get a free IELTS practice test

General Requirements

  • 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.
  • 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.

Getting a Student Visa

This is an online programme. You can attend from the comfort of your chair! So you don't need a student visa!

Tuition Fee

  • International

    12060 EUR/year
    Tuition Fee
    Based on the original amount of 12060 EUR per year and a duration of 18 months.
  • EU/EEA

    12060 EUR/year
    Tuition Fee
    Based on the original amount of 12060 EUR per year and a duration of 18 months.
We've labeled the tuition fee that applies to you because we think you are from and prefer over other currencies.

Funding

Check the programme website for information about funding options.

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

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