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Pharmaceutical Quality by Design

Pharmaceutical Quality by Design (QbD) is based on the application of product and process sciences, from early to late stages of the product development cycle. The course equips graduates with the relevant knowledge and skills to compete for global jobs in the pharmaceutical and healthcare sectors and academia.

Overview

 

Reasons to study Pharmaceutical Quality by Design at DMU:

  • 100 per cent of graduates seeking to enter employment or further study are successful within six months of graduating (DLHE 2013/14)
  • Our experienced practitioner and research-based academic staff have recently received grant-funded collaborative research and development to improve industrial process quality and efficiency, with Innovate UK (formerly TSB), the Engineering and Physical Science Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC)
  • Benefit from our extensive funding and investment in our industry standard laboratories and specialist equipment including USP IV dissolution and surface imaging dissolution, pilot scale twin-screw extrusion for continuous manufacture, electron microscope, thermal and mechanical analysers, freeze drying and tablet manufacturing facilities
  • 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
  • Become a graduate with current knowledge and skills required by the pharmaceutical industry. This is the first MSc dedicated to the new “Quality by Design” approach to pharmaceutical process and product development
  • The course content is aligned with the Guidelines from the International Conference on Harmonization (ICH) Q8, Q9, Q10 and Q11, an initiative being driven and supported by the US, EU and Japanese regulatory authorities

Scholarships:

At DMU, we are committed to helping our graduates enhance their careers and personal development through further study. We are proud to currently offer two scholarships.

Vice-Chancellor’s 2020 Scholarship
Up to 50 per cent of tuition fees offered to Home/EU DMU alumni for students who wish to continue their studies at DMU by enrolling on a Postgraduate taught course. For more information visit our Vice-Chancellor’s 2020 Scholarship page.

Vice-Chancellor's Sports Scholarship
Up to £6,000 worth of support available to full-time UK and EU undergraduate and postgraduate students, starting in September 2016. For more information visit our Vice-Chancellor's Sports Scholarship page.

More courses like this:

Quality by Design for the Pharmaceutical Industry

Advanced Biomedical Science

Pharmaceutical Biotechnology

  • UK/EU
  • International

Key facts for UK/EU students

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)

Location of study: De Montfort University Leicester UK

Fees and funding:
Full-time: £6,150

Find out more about course fees and available funding.

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

How to apply: International students can apply to study at DMU directly using our online portal or by submitting a direct application form.

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

 


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Key facts for international students

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)

Location of study: De Montfort University Leicester UK

Fees and funding:
Full-time: £14,500

Find out more about course fees and available funding.

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

How to apply: International students can apply to study at DMU directly using our online portal or by submitting a direct application form.

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

 


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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

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 facilties

Investment of £12 million in Health and Life Sciences has developed our first-class teaching and learning facilities to help you develop your practical experience and theoretical knowledge beyond the classroom.

Learn more about DMU’s first-class study facilities.

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 comfortable and well-equipped study areas provide a range of environments to suit your needs.

Originally set up in our main Kimberlin Library, the learning zones proved so popular that more were created in the Eric Wood Building and Greenhouse. These flexible spaces are ideal whether you are working as a group, practising a presentation or working quietly on your own.

They feature workstations with power supplies for laptops, plus bookable syndicate rooms with interactive whiteboards and DVD players. Eduroam wi-fi is available across all campus locations.

Opportunities and careers

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Scholarships

As part of the university's commitment to enhancing the personal and career development of our graduates. We offer an Alumni scholarship programme. For more information visit Health and Life Sciences Alumni Scholarships >

Name
Gunn and Carter Fellowship £3000 per annum. 

Description

To support research in the Leicester School of Pharmacy.

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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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How to apply

We welcome applications from UK and international students with a wide range of qualifications and experience.

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50% off selected PG courses

We are committed to helping our graduates enhance their careers and personal development through further study, which is why we offer the Vice-Chancellor’s 2020 Scholarship. This gives DMU graduates a tuition fee discount of up to 50 per cent on selected full-time and part-time postgraduate courses, based on academic achievement and merit. Find out more.

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The perfect way to find out more about DMU is to attend one of the postgraduate open evenings or events that take place all year round. If you can't visit the university in person, you can also sign up for one of our online chats. Find out more.

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Research at DMU

De Montfort University (DMU)’s growing reputation for research which benefits society has been confirmed with the publication of the REF 2014 results. Find out more.

 
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