Curriculum

This course provides an overview of the applications on Quality-by-Design practices as a key element of the drug regulatory science in the drug product and medical device development, manufacturing, control and assessment for the biotechnology and biopharmaceutical industries.

This course will give students a comprehensive view of a leader and a project manager, not just in the regulated world of biotechnology but across multiple industries. Besides the critical thinking and objective team discussion, students will learn from some highly experienced opinion leaders in the industry to improve on their managerial and moral perspectives in order to be a highly respected regulatory affairs professional and contribute high quality in an organization.

This course will provide an overview of the scientific, managerial and regulatory aspects in drug development. It will emphasize the quality controls, risk mitigation, and safety evaluation that are needed in this highly regulated product development process for small molecules, bio-therapeutics, or cell and gene therapies. A global perspective will be presented which span from drug discovery to pharmacovigilance.

The course will explore the regulations and requirements of new product filing process by which the global regulatory agencies have used successfully to safeguard the public interest from novel therapeutic drug products. Students will examine the extensive product development hurdles, documentation, validation, and quality control of every development step to assure a successful filing.

Management perspective of R&D process, methods for planning and organizing biotechnology ventures, basic concepts of intellectual property rights and methods and principles of marketing new technology-based products and services.

Introduction to biomarkers and its examination by medical device, with focus on utilization of biomarkers in pharmaceutical and biotechnology industry, and comprehensive overview on regulatory affairs and marketing strategy of its medical device.

Overview of methodology employed in identification of lead compounds, drug synthesis and development. Receptor screening technology for target identification, high-throughput screening for lead identification, and the process for turning a lead compounds into a marketable drug products.

Highlights in current applications of biotechnology on the research and development of nutraceutics and transgenic product. Scientific approach to natural product drug discovery, TCM-based health products, and nutritional products will be discussed.

The course aims to introduce the various regulatory policies and procedures in drug development across multiple jurisdictions globally, such as Food and Drug Administration (FDA), National Medical Products Administration (NMPA), European Medicines Agency (EMA), and International Conference on Harmonization (ICH). Current regulatory policies covering pre-clinical safety, manufacturing, clinical trials, and marketing authorizations will be examined during the drug development process.

A Quality Management System (QMS) is essential for pharmaceutical development, as it establishes a set of high standards and practices to ensure product safety and reproducibility. This course will illustrate the applications of the Quality by Design principle in pre-clinical, bio-manufacturing, clinical, and auditing processes of drug development.

This course provides a comprehensive overview of the impact from artificial intelligence and machine learning on drug discovery and development. During every stage of the drug development process, students will learn topics including biomedical image analysis, visualization of high dimensional data, data security, bioinformatics, and clinical decision milestones that can utilize artificial intelligence and machine learning.

This course will provide an overview of biomedical device regulations and the evolution of digital technologies and big data in pharmaceutical drug development, such as clinical studies. Its promises, progress, and problems are best illustrated with the resulting regulations on cyber security, data collection, labeling, and risk assessment.

Market access and sales revenue are critical considerations for the launch of a new drug product. This course will provide an overview of the global health care reimbursement schemes, promises, and challenges. Students will have a better understanding of the complexity in drug development decision in addition of the regulatory and clinical requirements.

The course is designed for biotech science and pharmaceutical professionals to develop and apply skills for data analysis with bio-statistical tools in biopharmaceutical drug development. Basic concepts in statistical principles will be discussed. Data analysis in drug development can include data generation from assays, pharmacokinetics, pharmacodynamics, anti-drug antibody testing and calculations for drug dosage in humans.

The course will provide valuable, complementary experience to students and encourage them to gain practical training by taking up industrial internships. The experience will give students the right skills to thrive in a pharmaceutical career. Industry professionals must be able to work together effectively at each stage of product development, from initial research through to marketing its release. Students are required to work at the places assigned by the supervisor, as well as to participate actively in the activities and events organized at the companies and industries. After the internship, students will be armed with the soft skills, laboratory techniques and industry contacts from running clinical trials, quality assurance, drug registration to selling pharmaceutical drugs that are required to start their career. Graded P or F.

This course is an intensive learning experience focused on the students’ specific areas of interest within Regulatory Affairs and their overall career aims. Students will develop a detailed project with a defined objective and deliverable. Students will work on the Capstone with advisement from a Capstone Advisor who will be selected for his/her expertise in the topic being addressed. Projects may align with students’ current employment or in a new area of interest. Students will implement the work under the supervision of a faculty member and will submit a deliverable that provides independent and novel insight into their project.

This course covers different aspects of product development management. Topics include innovation management, techniques for idea generation, QFD for incorporation of customers' needs in product design, and organizing and managing the development team. Projects and business plans will be carried out in the course.