Pharmaceutical Business & Technology

QQI Level 9 Post Graduate Diploma in Pharmaceutical Business & Technology.

COURSE OVERVIEW

This Post Graduate Diploma programme offers a unique blend of technology and business skills. Students will develop their skills in the pharmaceutical sector and gain expertise in Pharmaceutical Manufacturing, Business Improvement, Regulatory Affairs and Clinical Research. This unique and popular course is delivered by industry professionals ensuring you receive the most up to date and relevant skills to help you advance your career in the pharma/biotech sector.

With extensive input and participation from the pharmaceutical and clinical trials sectors, this course is ideal for those involved in manufacturing, compliance, business improvement, quality assurance, validation, data analytics, clinical trial coordination and engineering.

This course is suitable for those who possess qualifications at NFQ Level 8 Honours degree with a 2.2 or higher in a Science, Engineering or Quality discipline.

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.

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.

A full-time option is available for International Students.

CAREER OPTIONS

This highly desired qualification will help you open the door to an exciting and successful career in the pharma or life sciences industries. This unique masters' qualification could help kick-start your career progression as an executive, manager or director in the following specialities:

Business Operations Supervisor/ Manager
Compliance Specialist / Manager
Business Improvement Specialist
Clinical Trials Coordinator
Technology Specialist/ Manager
Quality Supervisor/ Manager
New Business Introduction Specialist