Online lectures take place two evenings per week (Monday, Wednesdays) with in-class lectures taking place two Saturday's per month in Griffith College Dublin & Griffith College Cork. (ECTS: 60 Credits)
A full-time option is available for International Students.
Module 1: Processes, Production and Pharmaceutical Quality Systems
Pharmaceutical & Biopharmaceutical manufacturing industry, pharmaceutical products, manufacturing, quality system elements, validation and change control, pharmaceutical plant design, pharmaceutical quality systems, principles of quality by design.
Module 2: Regulatory Landscape of Pharmaceutical Business
Pharmaceutical legislation and regulation, core principles, statutory frameworks, environmental regulations, Irish and European Union law, planning law, waste management, control of pollution, factory facilities.
Module 3: Pharmaceutical Technology Transfer
The technology Transfer process, research to manufacturing, location to location, life cycle studies, raw material impacts, pilot plan studies, validation, commissioning and cleaning, project management, regulatory framework, analytical methods.
Module 4: 21st Century Dynamics & Emerging Trends
Challenges facing the pharmaceutical industry, new product types, patent cliffs, emerging markets, innovative medicines, live licensing, modes of healthcare delivery, governmental strategies, demands on manufacturing and distribution.
Module 5: Strategy, Leadership & the Culture of Innovation
Current challenges of the pharmaceutical industry, strategic thinking in the Biopharmaceutical industry, leading change in the biopharmaceutical industry, culture of innovation, corporate governance and business ethics.
Module 6: Operational Excellence & the Science of Innovation
Origins of operational excellence, operational excellence implementation models, lean sigma implementation, design of six sigma, science of innovation, TRIZ, key performance indicators (KPI), quality function deployment.
Module 7: Clinical Research Management
Drug development life cycle, clinical trials project management, contract research organisations (CRO), competitive marketing in the clinical trials sector, managing commercial relationships.
Module 8: Research Methods
Topic selection, literature review, research design, methods of data collection and analysis, ethics.