Pharmaceutical Business & Technology

Overview
An exciting Masters programme developing your knowledge of Pharmaceutical Business, Regulation and Technology.

This unique Masters Degree Course is delivered by the Griffith Innopharma Faculty of Science and blends the subjects of pharmaceutical technology and business.

This programme is delivered in partnership with Innopharma.

Why Study Pharmaceutical Business and Technology with Innopharma Education at Griffith College?
The MSc in Pharmaceutical Business and Technology is conducted over a 1-2 year period and is available on both a full and part-time basis. The course focuses on core competencies such as pharmaceutical processes and production, pharmaceutical business introduction & technology transfer, emerging trends, operational excellence (Lean & Six Sigma), regulatory affairs, data analytics, strategic thinking and leadership development.
• Gain priceless practical experience within an ever-expanding industry
• Develop your professional skills to enhance career opportunities through the development of CVs and interview, networking, presentation and communication skills.
• All classes are broadcast live online offering the learners the opportunity to either physically attend or join the class online.
• Extensive coaching and mentoring workshops will be provided with a specific focus on individual assessment and improvement.
• Part-time learning allows students already working in the area extra time to hone skills.

Note: A full-time schedule is two taught semesters (60 credits) and one dissertation semester (30 credits).

Semester 1 (20 Credits)
Processes, Production and Pharmaceutical Quality Systems
• Pharmaceutical & biopharmaceutical manufacturing industry
• Pharmaceutical products
• Manufacturing
• Quality system elements
• Validation and change control
• Pharmaceutical plant design
• Pharma 4.0
• Pharmaceutical quality systems
• Principles of quality by design

Regulatory Landscape of Pharmaceutical Business
• Pharmaceutical legislation and regulation
• Core principles
• Statutory frameworks
• Current GMP regulations
• Irish and European Union law
• ICH proceedings
• Future regulations

Semester 2 (20 Credits)
Pharmaceutical Technology Transfer
• Technology transfer process
• Research to manufacturing
• Location to location
• Life cycle studies
• Raw material impacts
• Pilot plant studies
• Validation
• Commissioning and cleaning
• Project management
• Regulatory framework
• Analytical methods

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

Strategy, Leadership & the Culture of Innovation
• Current challenges of the pharmaceutical industry
• Strategic thinking in the bio/pharma industry
• Leading change in the bio/pharma industry
• Culture of innovation
• Corporate governance and business ethics

Semester 3 (20 Credits)
Operational Excellence & the Science of Innovation
• Origins of operations excellence
• Operational excellence implementation models
• Lean sigma implementation
• Design of six sigma
• Science of innovation
• TRIZ
• Key performance indicators (KPI)
• Quality function deployment

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

Semester 4/5 (30 Credits)
Research Methods
• Topic selection
• Literature review
• Research design
• Methods of data collection and analysis
• Ethics

Dissertation
• Abstract
• Introduction and rationale
• methodology
• Analysis & results
• Discussions and recommendations
• Presentation of dissertation

Applicants must hold a minimum qualification of an Honors degree (minimum 2.2 or higher) at NFQ Level 8 or higher in Science, Engineering or Quality or related discipline.

English Language requirements;
In response to the worldwide closure of English Language Test Centres arising from the Covid-19 pandemic, Griffith College is now accepting the online Duolingo English Test (DET) as valid proof of English proficiency. This is a temporary measure for our intakes up to and including February 2022.

How to Apply
Applicants should contact Orla McKiernan or a member of the Innopharma Education team at +353 1 485 3346 or via email.

Students can also apply directly through Griffith.ie

1 Year Full-Time / 2 Years Part-Time.

Part-Time Offering:
This two-stage programme is delivered 2 evenings per week (in class or online) and 2 Saturdays per month.

Full Time / International Offering:
Four days per week on campus.

Intake Dates:
We run two intakes for this course, commencing as follows:
Autumn: September*
Spring: February*

*subject to sufficient numbers.

Academic Progression
Options will depend on the academic requirements and the career choice of the learner.

Career Progression
Potential Roles for graduates of this course include:
• R & D Product Management
• Production/ Supervisory Management
• Quality/ Regulatory Affairs Roles
• Supply Chain Roles
• Project Management
• Process Improvement roles