The program 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 programme 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.
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.
Course assessment usually comprises of a comprehensive final exam and continuous assessment. Continuous assessment can include amongst others, weekly interactive activities, projects, positive online forum participation 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.
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”.