Postgraduate Courses

On successful completion of the course, students will be able to:

• 1.
  Demonstrate an understanding of the fundamentals of GxP and Quality Management Systems (QMS).
• 2.
  Demonstrate an understanding of the application of quality practices in the GxP, control, and assessment of biotech products.
• 3.
  Apply these QMS fundamentals to specific subsets of the biotechnology industry: including but not limited to devices, small molecules, biologics, and diagnostics.

On successful completion of the course, students will be able to:

• 1.
  Explain and describe the basic of the pyramid of success in leadership.
• 2.
  Define a quality-driven biotech organization with strong core values and leadership.
• 3.
  Understand and describe the qualities of a good regulatory team leader in the drug development process.
• 4.
  Understand and provide examples of good leadership in biotechnology to create a team-driven organization.
• 5.
  Describe and resolve the management balancing act in biotech industry.
• 6.
  Acquire and evaluate skills of an effective regulatory leader to solve product development issues.

On successful completion of the course, students will be able to:

• 1.
  Understand the scientific elements and decision points in drug development.
• 2.
  Identify risks and strategize mitigation plans during and after drug development.
• 3.
  Understand the rationale and basic management practices of quality control and quality assurance.
• 4.
  Analyze and evaluate regulatory compliance for life science products.
• 5.
  Explain the process in ADME (absorption, distribution, metabolism, excretion) testing and toxicity studies in pharmaceutical development.
• 6.
  Formulate and fill for a REMS (Risk Evaluation and Mitigation Strategies) plan.
• 7.
  Develop project management objectives and schedules.

On successful completion of the course, students will be able to:

• 1.
  Describe the differences between a Drug versus a New Drug.
• 2.
  Explain the processes of a New Drug Application (NDA) and Biologics License Application (BLA).
• 3.
  Define a Risk Evaluation Mitigation Strategy (REMS) and explain the requirements.
• 4.
  Explain how an Investigational New Drug (IND) impacts an NDA/BLA.
• 5.
  Describe the importance of preclinical and clinical studies in the New Drug filing with the regulatory agencies.
• 6.
  Explain the hurdles and processes for an Abbreviated New Drug Application (ANDA) as an important alternative to the NDA.
• 7.
  Explain the hurdles and process for a biosimilar application as an important alternative to the BLA.
• 8.
  Describe the device submission process.

On successful completion of the course, students will be able to:

• 1.
  Possess an in-depth understanding of the various regulatory policy making rationales across FDA, NMPA, or EMA.
• 2.
  Learn key regulatory policies and guidance documents related to discovery, preclinical studies, Chemistry, Manufacturing, and Controls (CMC) process, and clinical studies of drug products.
• 3.
  Define a Risk Evaluation Mitigation Strategy (REMS) and explain its policy.
• 4.
  Describe the preclinical and clinical policies relevant in New Drug filing across global regulatory agencies.
• 5.
  Understand market access, reimbursement, and pricing policies for pharmaceutical products.

On successful completion of the course, students will be able to:

• 1.
  Describe the applications of the Quality by Design principle in pre-clinical, bio-manufacturing, clinical, and auditing processes of drug development.
• 2.
  Understand the international differences in approach to Quality Systems and Compliance.
• 3.
  Understand the importance of clear documentation practices.
• 4.
  Learn the previous industrial mistakes and incorrect practices through consent decrees.
• 5.
  Propose meaningful solutions and cost saving initiatives in quality practices.
• 6.
  Identify risk management strategy based on Quality by Design.

On successful completion of the course, students will be able to:

• 1.
  Understand the recent developments in drug discovery and data analysis with artificial intelligence (AI) and machine learning (ML).
• 2.
  Describe the advancements, challenges, and opportunities of using AI in drug discovery.
• 3.
  Understand some algorithms associated with AI and ML with the analyses of multiple datasets generated throughout the drug development stages.
• 4.
  Describe the use of AI/ML in clinical diagnostic image analysis and real-world clinical datasets.
• 5.
  Describe the regulatory policy proposed in the management of AI/ML in drug development.

On successful completion of the course, students will be able to:

• 1.
  Learn the benefits and risks of big data utilization in drug development.
• 2.
  Learn the impact of digital technologies on clinical studies.
• 3.
  Discuss some of the regulatory guidelines on data storage and cyber security.
• 4.
  Understand the regulatory challenges and opportunities in using digital health technologies.
• 5.
  Apply risk assessment and mitigation strategy from using digital health technologies.

On successful completion of the course, students will be able to:

• 1.
  Learn the decision behind national pricing and reimbursement schemes for pharmaceutical products across multiple countries.
• 2.
  Understand the global gap between insurance payers and government regulators.
• 3.
  Explain some of the tariff and non-tariff barriers, in addition to cultural requirements.
• 4.
  Describe the major pharmaceutical markets globally and their general regulations.
• 5.
  Design strategy or mitigation scheme in marketing drug products or devices to different regions of the world.

On successful completion of the course, students will be able to:

• 1.
  Demonstrate understanding of the statistical principles of the data analysis resulting from testing of candidate drugs produced by the biopharmaceutical industries.
• 2.
  Apply statistical tools and methods for case studies and sample calculations.
• 3.
  Acquire knowledge of biomedical instrumentation and methodologies for drug testing and data generation.
• 4.
  Deploy scientific and reasoning skills for evaluation of test results.

On successful completion of the course, students will be able to:

• 1.
  Differentiate professional and unprofessional behavior within the workplace.
• 2.
  Employ degree-related functions, such as operating laboratory equipment, conducting research methods, analyzing data, executing administrative tasks (i.e., planning, communications, file management, marketing/social media, office operations).
• 3.
  Recognize and describe host site terminologies, issues, and trends.
• 4.
  Relate coursework concepts to host site experiences.

On successful completion of the course, students will be able to:

• 1.
  Assimilate up-to-date regulatory information and convert it into knowledge by recognizing the principles and practice patterns underpinning why new regulations are needed and how they evolve.
• 2.
  Identify and develop skills needed to achieve predictable outcomes of regulatory submission and communications.
• 3.
  Experience via real-world case examples to identify key principles essential for effective regulatory submission planning communication within a corporation and regulatory authorities.
• 4.
  Be active participants to experience technical, regulatory, and commercial challenges of Regulatory Science, to appreciate the rewards in learning to distinguish between information and knowledge and how to empower their self-development.