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