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Regulatory Affairs For Pharmaceutical Science

  • Module code: CH6400
  • Year: 2018/9
  • Level: 6
  • Credits: 30
  • Pre-requisites: None
  • Co-requisites: None

Summary

This module sets out to develop the theme of regulatory affairs. The regulation of medicines is dealt with both within a general framework and specific areas including manufacturing, dealing with specialist products, regulation in clinical use, and licensing. Medicines (and devices) regulation within the UK and abroad and the supra-national framework will be described and knowledge developed. Regulatory matters will be related to previous module experience, so that you will develop an understanding of how the regulations intertwine with practical and scientific considerations. This module introduces you to the different phases and types of clinical trials and the associated legal, regulatory and ethical issues.

Aims

  • To understand how, by the application of good practices, a medicine can be considered to be safe, effective, and of good quality.
  • To enable students to undertake detailed review of the progress of medicinal products from instigation to patient.

Learning outcomes

On successful completion of the module, students will be able to:

  • Apply regulations in order to review results from ingredients, medicines and medical devices under test or in therapeutic use, to make judgement of these data and to make valid recommendations or warnings where appropriate.
  • To analyse aspects of pharmaceutical development and manufacturing including traditional Quality Assurance processes, and Quality by Design and Process Analytical Technologies (PAT).
  • Contextualise the testing of medicines and medical devices in volunteers and patients (both veterinary and human), with the role of statistics and clinical data management.
  • To provide examples of applications of techniques for analysis, synthesis, formulation, packaging etc to the regulation of medicines and medical devices, and relate regulation to laboratory skills

Curriculum content

  • What are regulatory affairs? 
  • How regulations arise; legislation, feedback and practice
  • Quality, safety, efficacy, cost
  • Definitions of medicinal products and devices
  • Regulatory input into drug development
  • The product lifecycle (Initiation, research development, optimisation and maturity)
  • The regulatory framework for active pharmaceutical ingredients, medicines, medical devices at the stage of licensing, post-licensing and in clinical trials
  • The major regulatory authorities  and their roles; MHRA, EMA, FDA, TGA, MHLW and ICH et al.
  • The legal, regulatory and ethical aspects of trials in humans and animals.
  • Data analysis.  Statistical manipulation and presentation.
  • Utilising medicines in different medical spheres, and the move from one to another - veterinary or human, line extensions, prescription-only vs. Over the Counter, allopathic vs. alternative, and so forth.
  • The control of manufacture including Good Manufacturing Practice, Manufacturing Licences, and Standard Operating Procedures.
  • The industrial production and analytical monitoring of a variety of pharmaceutical dosage forms and medical devices (including drug device combinations): tablets, capsules, parenteral preparations, disperse systems, respiratory, dermal and transdermal products
  • Pharmaceutical pre-formulation and links to regulation and the quality documents.
  • In vivo deposition of pharmaceutical formulations: bio-availability, bio-equivalence, pharmacodynamics, pharmacokinetics, and the concept of bio-pharmaceuticals
  • Compliance of laboratory work, Quality Assurance and Quality Control with respect to the pharmaceutical industry; Accreditation of pharmaceutical analytical laboratories and device analysis.
  • Applications of chromatographic and spectroscopic methods to pharmaceutical products.
  • Thermal analysis applied to pharmaceutical products.
  • Routine pharmaceutical analysis as described in the British Pharmacopoeia e.g: loss on drying, arsenic limit tests, Karl Fischer
  • Challenges for the analyst posed by sterile product manufacture.
  • PAT; techniques such as Raman and NIR.
  • Communication using marketing, advertising, labelling, patient information leaflets
  • Pharmacovigilance
  • Legal and intellectual property

Teaching and learning strategy

This module is delivered through a variety of lectures, workshops and problem based learning exercises. Lectures and practicals are designed to introduce students to the key features of each topic at an advanced level and to lay the preparatory ground for the application of knowledge to a market authorisation application (MAA).

Breakdown of Teaching and Learning Hours

Definitive UNISTATS Category Indicative Description Hours
Scheduled learning and teaching 20 two hour lectures 12 one hour workshops x 2 three hour practicals 40 12 6
Guided independent study Directed private study & Self-directed learning 242
Total (number of credits x 10) 300

Assessment strategy

Students are assessed through the end-of-module exam (40%) on topics dealt primarily within the lectures and the directed private study. Course work assessment consists of two parts. The first comprises a portfolio (30%) designed to instil the skills required to allow completion of a hypothetical marketing authorisation application (MAA) submitted towards the end of the module. The portfolio consists of three pieces of work equally weighted at 10%, two of which concern the analysis of results generated in the laboratory, in the context of relevant regulations. The third element involves the students undertaking statistical and qualitative review of regulatory data provided by the module team. Students will then prepare their MAA (30%) for a specified product, in line with regulations. Workshops and formative assessments will allow discussion of the work undertaken independently by the students to improve confidence among students especially in tackling complex topics covered in lectures and the application of regulations.

Mapping of Learning Outcomes to Assessment Strategy (Indicative)

Learning Outcome Assessment Strategy
Apply regulations in order to review results from ingredients, medicines and medical devices under test or in therapeutic use, to make judgement of these data and to make valid recommendations or warnings where appropriate. Portfolio MAA
To analyse aspects of pharmaceutical development and manufacturing including traditional Quality Assurance processes, and Quality by Design and Process Analytical Technologies (PAT). Exam Portfolio MAA
Contextualise the testing of medicines and medical devices in volunteers and patients (both veterinary and human), with the role of statistics and clinical data management. Exam Portfolio MAA
To provide examples of applications of techniques for analysis, synthesis, formulation, packaging etc to the regulation of medicines and medical devices, and relate regulation to laboratory skills Exam Portfolio MAA application

Elements of Assessment

Description of Assessment Definitive UNISTATS Categories Percentage
Examination Written exam 40%
Portfolio Coursework 30%
MAA Coursework 30%
Total (to equal 100%) 100%

Achieving a pass

It IS NOT a requirement that any element of assessment is passed separately in order to achieve an overall pass for the module.

Bibliography core texts

These books are for reference - students are not expected to purchase these books.

  • British Pharmacopoeia current edition
  • ICH, EMA, MHRA and FDA - current materials online
  • Design and Analysis of Clinical Trials Concepts and Methodologies 3rd ed.. Shein-Chung Chow ;Jen-Pei Liu ;2013 ebook available
  • M.G.De Jong, FAQs on EU Pharmaceutical Regulatory Affairs, Brookwood Medical Publications, [most recent version], ISBN 1 874409 17 X
  • Pharmaceutics. The Design and Manufacture of Medicines, M.E Aulton, 4th edition, Churchill Livingstone (2013)
  • Pharmaceutical biotechnology : fundamentals and applications 3rd ed., 2007, Edited By Daan J.A. Crommelin, Robert D. Sindelar, Bernd Meibohm eBook
  • Aulton M.E. (Ed.) Pharmaceutics: The Science of Dosage Form Design, 3rd Edition, Churchill Livingston (2007)
  • J. Sharp (Ed.), Quality in the Manufacture of Medicines and Other Health Care Products, Pharmaceutical Press, (2000), ISBN 0853694311
  • E. Prichard, Analytical Measurement Terminology, Royal Society of Chemistry, (2001), ISBN 0854044434
  • B. Neidhart, W. Wegscheider, (Eds.), Quality in Chemical Measurements, Springer-Verlag, (2001), ISBN 3540659943

 

Bibliography recommended reading

  • D. R. Hutchinson, How drugs are developed: a practical guide to clinical research, Brookwood Medical Publications, PJB, [most recent version], ISBN 1 874409 86 2
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Quality and Clinical guidelines URL: www.ich.org
  • Todd A Durham and J Rick Turner, Introduction to statistics in pharmaceutical clinical trials, Pharmaceutical Press, 2008, ISBN: 978-0-85369-714-5
  • Long ActingInjectionsand ImplantsJeremy C. Wright; Diane J Burgess (editors); SpringerLink; 2012 Available as ebook through iCat
  • FASTtrack: Pharmaceutics - Drug Delivery and Targeting Y Perrie,T Rades; Pharmaceutical Press; 2012 Available as ebook through iCat
  • A concise guide to clinical trials, Allan K. Hackshaw ;c2009 ebook available
  • David Jones, FASTtrack: Pharmaceutics - Dosage Form and Design, Pharmaceutical Press, 2008, ISBN: 978 0 85369 764 0.
  • Selected URL: www.abpi.org.uk, www.medicines.ie, emc.medicines.org.uk, www.tga.gov.au.
  • E McFadden, Management of Data in Clinical Trials, J Wiley & Sons, 2007, ISBN: 978-0-470-04608-1
  • Gavin Brooks, (ed.), Biotechnology in healthcare: An introduction to biopharmaceuticals, Pharmaceutical Press, London [most recent version], ISBN 0 85369 372 2.
  • David Robert Karsa and R.A. Stephenson (eds.) Excipients and delivery systems for pharmaceutical formulation, Springer-Verlag, [most recent version], ISBN 0854047158.
  • European Commission DGIII, Eudralex, Notice to applicants: The Rules Governing Medicinal Products in the European Union, Brussels. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm
  • European Pharmacopoeia, European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France; 6th edition, June 2007, ISBN 978-92-871-6060-7. www.edqm.eu/site/The-European-Pharmacopoeia-6th-Edition-681.html, accessed 27/01/2009.
  • The Blue Guide: Advertising and Promotion of Medicines in the UK, 2nd rev. ed., Medicines and Healthcare products Regulatory Agency (MHRA), 2005, ISBN: 9780117036048.
  • Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 ('The Orange Guide'); MHRA, Department of Health and the Pharmaceutical Press, ISBN 9780853697190.
  • Practical Guide to Medical Device Vigilance, Brookwood Medical Publications, PJB, [most recent version], ISBN 1 874409 08 0
  • A.T. Florence & D. Attwood, Physico-Chemical Principles of Pharmacy 5th Edition, Palgrave Publishing, United Kingdom (2006).
  • Remington: The Science and Practice of Pharmacy. 21st Edition, Lippincott, Williams & Wilkins Publishers, Philadelphia (2006)
  • R. Kellner, J.-M. Mermet, M. Otto, H.M. Widmer. (Eds.), Analytical Chemistry: A Modern Approach to Analytical Science, Wiley VCH, (2004), ISBN 3527305904
  • United States Pharmacopoeia: AND the National Formulary, 21st Ed. (United States Pharmacopeia), US Pharmacopoeia Convention, Inc, (2003), ISBN 1889788139
  • Martindale: The Complete Drug Reference, Pharmaceutical Press, 35th ed., 2007, ISBN 085369687X

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