Honours Degree in Pharmaceutical Business Operations

Course Outline

This course is delivered over 2 years. Students have the option to enter at year 1 or year 2 depending on their prior qualifications. (ECTS: 120 Credits)

Year 1

Module 1: Pharmaceutical Manufacturing

Pharmaceutical dosage forms; drug product formulation and their chemical function; pharmaceutical manufacturing processes; quality control release testing requirements; stability testing; process validation; change control

Module 2: Management & Organisational Behaviour

Organisational structure and design; organisation culture and change; management & leadership; organisational control and power; workgroups and teams in organisations

Module 3: Operations Management

Operations management; sales & operations planning; planning control and improvement; performance measurement; operational governance

Module 4: Regulatory Affairs & Validation

Regulatory requirements for pharmaceutical manufacturing; distribution and clinical trials; elements of typical cGMP quality systems; clinical trials; pharmaceutical manufacturing; pharmaceutical distribution; marketing authorisation application; current trends in cGMP.

Module 5: Operational Excellence – Lean Sigma

Lean thinking; six sigma; project planning; process mapping; root cause analysis; creative solutions; corrective action preventative action; statistics; data visualisation; presentation skills; effective decision making

Module 6: Control Systems and Real-Time Analytics

Control and data management systems; system development lifecycle; process analytical technologies; real-time control system; critical quality attributes

Module 7: Clinical Research Co-Ordination

Research & development process; clinical studies; statistical concepts in a clinical study; drug safety system; regulations & directives applicable to clinical trials; GCP inspection; clinical study reports & clinical overview

Module 8: Career Progression

Fundamentals of developing a successful CV; cover letters; presentation and communications skills; networking; interviewing skills; personal coaching & mentorship

Year 2

Module 1: Pharmaceutical Quality Management Systems 

Pharmaceutical quality systems; validation; change control; investigations; audit performance; annual product reviews (APR); quality metrics; quality risk management.

Module 2: Pharmaceutical Manufacturing & Distribution

Biopharmaceutical manufacturing overview; pharmaceutical packaging; good distribution practice; product release; falsified medicines directive.

Module 3: Strategic Management

Introduction to strategic management; scanning the environment; strategy formulation; strategy implementation & change management; evaluation and control. 

Module 4: Clinical Research

Drug development lifecycle; phases of clinical research; primary regulations & directives; GCP auditing/pharmacovigilance; clinical pharmacology.

Module 5: Project Planning & Finance

Project management; project initiation & conceptualisation; project scheduling and time management; project budgeting/costing; project closure & communication; project leadership & communication; risk management.

Module 6: Professional & Technical Communications 

Career preparation skills; CV development; Interview skills; technical communications.