Pharmaceutical Quality by Design MSc/PG Dip/PG Cert

About the course

Quality by Design (QbD) is based on the application of product and process sciences, from early-to-late stages of the product development cycle, to provide accelerated regulatory submission pathways for new drug applications.

• This is the first MSc dedicated to the new QbD approach to pharmaceutical process and product development
• Our established reputation of more than 104 years pharmacy teaching ensures we produce graduates of the highest calibre
• It informs part of a major initiative, being driven and supported by the US, EU and Japanese regulatory authorities, and defined within the Q8, Q9 and Q10 Guidelines from the International Conference on Harmonization (ICH)
• 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 the Technology Strategy Board, and Engineering and Physical Science Research Council
• Benefit from our extensive funding and investment in our industry standard laboratories and specialist equipment
• Our strong links, direct input and guest lectures from industrial experts ensure your learning is relevant to current practice and developments within the sector

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Key facts

Duration: One year full-time

Attendance: Expected to attend university full-time, up to 10 hours per week (please note this is subject to change)

Start date: September 2014

Entry and admission 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.

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, is available both before and during the course if you need it.

To find out more, please visit dmu.ac.uk/international|

Teaching and assessment

The learning environment for the first two semesters will be varied with lectures, tutorials, seminars, laboratory-based practicals 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.

International students come to study in the UK because the quality of our teaching is amongst the best in the world, offering a varied selection of teaching methods to suit all learning requirements.

Course modules

The Pharmaceutical Quality by Design course will provide an understanding of the challenges faced by the pharmaceutical and healthcare industries (as they strive to develop new products) and equip 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 has been structured to ensure you have a coherent and balanced programme of study in the following areas:

• Principles and Practices of Quality by Design (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, Control and Manufacturing (15 credits)
  considers the design, including facility, equipment, material transfer, and manufacturing variables using QbD principles.

• Advances in Drug Delivery (15 credits)
  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)
  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.

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, such as:

• FACS analyser
• Confocal microscope
• Electron microscope
• Mass spectrometer
• Fermentation units
• Tissue culture suites

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) grant-funded collaborative research and development, aimed to improve industrial process quality and efficiency.

Industrial practitioners will also be engaged to give guest lectures, in addition to drawing on the web-based learning material created by industrial practitioners.

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.

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:

• Manufacturing co-ordinator
• Formulation scientist
• Senior analyst
• Research analyst
• Regulatory affairs associate
• performance manager
• Senior device technologist
• Product development scientist

Fees and funding

UK/EU Full-time £5740 International Full-time £12,500 Distance Learning 15 Credit module £980 30 Credit module
£1390 60 Credit dissertation
£2000

Scholarships

As part of the universities commitment to enhancing the personal and career development of our graduates. We are pleased to announce the launch of the 2013/14.
Alumni scholarship programme. For more information visit Health and Life Sciences Alumni Scholarships >|

Pharmaceutical Cosmetic Sciences Alumni Scholarships|