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Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

Focusing on pharmaceutical science and technology – the application of sciences to product development cycle – this course will equip you with the knowledge and skills to pursue careers in industry or research in the pharmaceutical and healthcare sectors.

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Overview

Applications can be made using the postgraduate application form, or using the online portal. Please send any queries to hlsadmissions@dmu.ac.uk

Our Leicester School of Pharmacy has an established reputation of more than 100 years of pharmacy teaching. This course is dedicated to applying international regulatory guidelines used by all big pharmaceutical industries to pharmaceutical manufacture and product development. 

Our teaching staff are experienced practitioners and researchers, and offer academic and industrial expertise underpinned by Quality by Design principles. You will learn about the challenges faced by the pharmaceutical and healthcare industries in product formulation, material science, advanced analytical sciences, and process engineering and control, as they strive to develop new products and create safe medicines. 

Your learning will benefit from our strong industry links, with support from guest lecturers and other experts within the sector. This insight ensures that your studies will be up to date with current practice and developments, preparing you to progress into a wide range of careers, from product development and manufacturing to regulatory affairs, marketing, and clinical research. 

Extensive investment in our industry-standard laboratories means that you will have access to specialist equipment throughout your studies. This includes a continuous manufacture platform using a novel in-line based on UV-Vis spectroscopy, powder flow and compression technology, thermal and mechanical analysers, freeze drying and tablet manufacturing facilities.

Key features

  • Our experienced academic staff have research projects supported by Innovate UK and the Engineering and Physical Sciences Research Council
  • This programme prepares you for a wide variety of pharmaceutical career opportunities, from product development and manufacturing to regulatory affairs, marketing, and clinical research.
  • Benefit from strong links, direct input and guest lectures from industrial experts ensuring your learning is relevant to current practice and developments within the sector.
  • Study a range of modules, including Analytical Techniques in Materials Science, Process Design, and Manufacturing and Biopharmaceuticals.

Scholarships:
At DMU, we are committed to helping our graduates enhance their careers and personal development through further study.

DMU Sport Scholarship
Find out more about the DMU Sport Scholarships worth up to £6,000.

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  • UK
  • EU/International

Institution code: D26

Duration:
One year full-time

Attendance:
Expected to attend university full-time, average of 15 class contact hours per week (please note this is subject to change)

Start date: September 2022

Location of study: De Montfort University Leicester UK

Fees and funding:

2021/22 tuition fees for UK students: £7,050

Find out more about postgraduate course fees and available funding.

Find out more about additional costs and optional extras associated with this course.

Please visit dmu.ac.uk/international for more information or call us on +44 (0)116 2 50 60 70.

 

Institution code: D26

Duration:
One year full-time

Attendance:
Expected to attend university full-time, average of 15 class contact hours per week (please note this is subject to change)

Start date: September 2022

Location of study: De Montfort University Leicester UK

Fees and funding:

2022/23 tuition fees for EU and international students: £16,800

Find out more about postgraduate course fees and available funding.

Find out more about additional costs and optional extras associated with this course.

Please visit dmu.ac.uk/international for more information or call us on +44 (0)116 2 50 60 70.

 

Entry criteria

  • A good honours degree (minimum 2:2 or equivalent) in a chemical, biological or physical science, including (though not exclusive to) chemistry, biology, chemical engineering, engineering, pharmacy, pharmaceutical science, or physics (or equivalent)
  • Alternatively, we will accept a portfolio of professional and/or academic qualifications of equivalent standing to an honours degree.

 

English language requirements:

If English is not your first language an IELTS score of 6.5 or equivalent when you start the course is essential. English language tuition, delivered by our British Council accredited Centre for English Language Learning (CELL), is available both before and during the course.

Please visit dmu.ac.uk/international for more information.

 

Structure and assessment

 

Course modules

Teaching and assessment

Academic expertise

 

Course modules

The Pharmaceutical Quality by Design course will provides an understanding of the challenges faced by the pharmaceutical and healthcare industries as they strive to develop new products and equips you with modern product development and manufacturing solutions that conform to current industry best practices and modern QbD principles.

The course contains areas of core knowledge and skills with an emphasis on application of QbD principles and continuous improvement activities to the development and manufacture of pharmaceutical products. 180 credits must be completed to achieve a full master’s. The course is structured to ensure you have a coherent and balanced programme of study in the following areas:

  • Quality by Design - QbD (15 credits) - explores a variety of legislation and regulations relating to the quality of pharmaceutical products.
  • Product Design: Pre-formulation and Formulation (30 credits) - introduces a variety of techniques and methods to formulate and produce safe medicines.
  • Analytical Techniques in Materials Science (15 credits) - builds on the concept of materials science as a separate discipline.
  • Process Design and Manufacturing (15 credits) - considers the design, including facility, equipment, material transfer, and manufacturing variables using QbD principles.
  • Advances in Drug Delivery (15 credits elective) - focuses on new therapeutic entities and delivery strategies. It is intended to integrate with ideas in other subject areas presented in the course, but also for the appreciation of future developments.
  • Biopharmaceuticals (15 credits elective) - covers the use of large molecules, including those derived from biotechnology and especially those that are biologically active to produce therapeutic responses.
  • Process Analytical Technology and Chemometrics (15 credits) - describes online process monitoring and the use of Process Analytical Technology (PAT) to advance pharmaceutical process identification, simulation and control.
  • Experimental Design and Research Methods (15 credits) - focuses on research and experiment design methods applying QbD principles. The importance of design space concept will be discussed. Issues are primarily illustrated through examples from industrial cases.
  • Dissertation (60 credits) - aims to provide each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical science by carrying out a research or development project in an area directly related to pharmaceutical manufacturing

Note: All modules are indicative and based on the current academic session. Course information is correct at the time of publication and is subject to review. Exact modules may, therefore, vary for your intake in order to keep content current. If there are changes to your course we will, where reasonable, take steps to inform you as appropriate.

Teaching and assessment

The learning environment for the first two semesters is varied with lectures, tutorials, seminars, laboratory-based practical’s and computer laboratories. In the third semester the learning venue will depend on your dissertation topic and will be much more aimed at guided self-study.

The course uses a variety of assessment methods relevant to a master’s level of study. The assessments include oral presentations, group work assignments, case study reports, essay writing, a research proposal and a final dissertation. 

Teaching contact hours

Contact hours in a typical week will depend to some extent on the optional modules you choose to study. However, typically you will have an average of 15 contact hours of teaching and this will break down as:

Personal tutorial/small group teaching: 1 hour of tutorials (or later, project supervision) each week

Medium group teaching: 4 hours of practical classes, workshops or seminars each week

Large group teaching: 10 hours of lectures each week

Personal study: 10 hours studying and revising in your own time each week, including some guided study using hand-outs and online activities.

 

Academic expertise

We have received major funds for development of our laboratories and equipment. This has allowed the purchase of equipment that matches those in the best industrial laboratories including:

  • Twin-screw extrusion for continuous process manufacture
  • Powder flow analysis
  • Nanoparticle characterisation
  • Terahertz imaging and spectroscopy
  • NIR and Raman spectroscopy
  • Dynamic dissolution USP IV and imaging dissolution tests
  • Electro-hydrodynamic spraying of micro-particles
  • Thermal analysis;
  • Rheology
  • Atomic force microscopy and SEM.

The core staff have been teaching for many years and have academic and industrial experiences in areas that underpin the QbD principles. These are product formulation, material science, advanced analytical sciences, and process engineering and control.

The group has evidenced its capability in this regard through recent success with the Technology Strategy Board (TSB), and Engineering and Physical Science Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC) grant-funded collaborative research and development, aimed to improve industrial process quality and efficiency.

Pharmacy has been taught in the faculty for over 100 years and we have gained a reputation for producing high quality graduates. Teaching expertise is of the highest calibre and many academics have experience working in the sector.

Facilities and features

Health and Life Sciences facilities

Substantial investment has developed our teaching and learning facilities to help you expand your practical experience and theoretical knowledge beyond the classroom.

The 19th century Hawthorn Building has facilities designed to replicate current practice in health and life sciences, including contemporary analytical chemistry and formulation laboratories, audiology booths and nursing and midwifery clinical skills suites.

Purpose-built clinical skills areas allow you to practice in a safe environment. You will receive guidance and support from staff to ensure that you develop a precise and accurate practical ability in the clinical skills suites.

QBD methodology

QbD methodology is becoming more established in the Pharmaceutical sector and is also recognised by the regulatory authorities at a time when the industry is under pressure to deliver efficiencies in manufacturing and drug development.

The University is supporting the creation of a centre for “Continuous Pharmaceutical Development, by continuous processing, within a Quality by Design framework. The centre will offer unique hands on experience to the students in areas such as process analytical technologies, continuous improvement and life cycle management of medicines.

Learning zones

Our Learning Zones and The Greenhouse also provide space for group or individual work and study.

There are 1,600 study places across all library locations, more than 700 computer stations, laptops to borrow, free wi-fi and desktop power outlets.

You can also book rooms with plasma screens, laptops and DVD facilities for group work and presentations, secure an individual study room with adjustable lighting or make use of our assistive technology.

Opportunities and careers

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Graduate careers

This course equips graduates with the relevant knowledge and skills to compete for jobs in pharmaceutical and healthcare sectors linked to industry or academia all over the world. There are career opportunities in areas such as product development, manufacturing, regulatory affairs, marketing and clinical research, and jobs include:

  • Product Lifecycle Manager
  • Oral Solid Dose (OSD) Technologist
  • OSD Industrialisation Lead
  • Production Technologist
  • Senior analyst
  • Regulatory affairs associate performance manager
  • Senior device technologist
  • Product development scientist 

 

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