UCC College Calendar

Note: Every effort has been made to ensure that the programme and module content as described in the University's Calendar and Book of Modules for the 2020-21 academic year are accurate. However, due to the Coronavirus (COVID-19) pandemic, no guarantee is given that programme/module content, delivery and assessment may not be altered, cancelled, replaced, augmented or otherwise amended. Any changes will ensure the same competencies and Learning Outcomes are met. Programme and/or Module Coordinators will communicate any such changes to students.

General

The Postgraduate Diploma in Pharmaceutical Regulatory Sciences is a full time programme delivered in a blended format, running over 12 months from the date of first registration for the programme.

Entry Requirements

Applicants are expected to hold an honours primary degree (NFQ Level 8), minimum second-class honours grade one, or equivalent, in a science health-related, numerate or quantitative business field. This includes BSc degrees in chemical, biological and medical sciences, pharmacy, mathematical and computer science, engineering, public health, and business information systems.

Programme Requirements

Students must satisfactorily complete taught modules to the value of 45 credits and an industrial-based project to the value of 15 credits.

Students take 60 credits as follows:

EH6136 Pharmacoepidemiology (5 credits)
EH6137 Pharmaceutical Data Management and Pharmacovigilance (5 credits)
PF6026 Pharmaceutical Technology and Unit Operations with Regulatory Insights (5 credits)
PF6027 Pharmaceutical GxP and Regulatory Science (5 credits)
PF6028 Process Control and Validation for Pharmaceutical Processes with Regulatory Insights (5 credits)
PF6029 Biotechnology-derived and Advanced Therapy Medicinal Products (ATMPs) with Regulatory Insights (5 credits)
PF6030 Industrial-based project and skills development for an industry-based setting (15 credits)
ST6024 Introduction to Probability and Statistics (5 credits)
ST6025 Statistical Modelling (5 credits)
ST6026 Basics of Machine Learning (5 credits)

Module Semester Information may be found here. Module Descriptions may be found here.

Examinations
Full details and regulations governing Examinations for each programme will be contained in the Marks and Standards 2020/2021 Book and for each module in the Book of Modules, 2020/2021.

Programme Learning Outcomes

Programme Learning Outcomes for Postgraduate Diploma in Pharmaceutical Regulatory Sciences (NFQ Level 9, Major Award)
On successful completion of this programme, students should be able to:

Draw inferences about population parameters based on sample estimates, including the interpretation of confidence interval estimates, and interpretation of statistical hypotheses tests.
Interpret statistical models (regression and generalized linear models) fitted using R software.
Identify appropriate machine learning techniques for a given dataset
Evaluate major process parameters and critical quality attributes for different manufacturing processes, including conventional medicines and advanced therapy medicinal products.
Interpret the regulatory requirements for approval, licensing and manufacture of medicinal products in the EU, with reference to the relevant EU legislative frameworks.
Assess and distinguish between the methods employed in statistical process control.
Explain approaches to validation throughout the pharmaceutical life cycle and prepare a qualification and/or validation document.
Apply principles of pharmacoepidemiology and critically appraise studies, including appropriateness of the data source, the methods and the interpretation of findings .
Demonstrate understanding of pharmacovigilance, including history, current guidelines and frameworks for pharmacovigilance, detection and reporting of adverse findings.