PM4PYE3: Pharmaceutical Industry

Module code: PM4PYE3

Module provider: Pharmacy; School of Chemistry, Food and Pharmacy

Credits: 20

Level: Level 4 (Undergraduate Masters)

When you'll be taught: Semester 2

Module convenor: Dr Hisham Al-Obaidi, email: h.al-obaidi@reading.ac.uk

Pre-requisite module(s):

Co-requisite module(s):

Pre-requisite or Co-requisite module(s):

Module(s) excluded: IN TAKING THIS MODULE YOU CANNOT TAKE PM4PYE1 OR TAKE PM4PYE2 OR TAKE PM4PYE4 (Compulsory)

Placement information: NA

Academic year: 2024/5

Available to visiting students: No

Talis reading list: Yes

Last updated: 21 May 2024

Overview

Module aims and purpose

This module introduces students to the drug discovery and development process, from compound selection, pre-formulation, development, clinical research, to product launch and distribution. Students will gain a comprehensive understanding of the scientific, regulatory and commercial principles underpinning drug discovery and development, with specific analysis of key approaches and practices employed by the pharmaceutical industry. An important aspect of the module is to develop the students' practical skills in formulation and product evaluation. This will be undertaken through a mock drug development project. The combination of lectures, and workshops will enable students to be equipped with knowledge and skills, which will enhance their understanding of drug discovery, development, marketing and distribution of new drug products as well as future employability in this global industry. At the end of this module students will have achieved the fundamental knowledge needed for students thinking about pursuing a career within the pharmaceutical industry.Ìý The module will include seminars delivered by experts in pharmaceutical industry and experienced academics in this field.Ìý It will include a day visit to a pharmaceutical company to show daily activities which will also give students a chance to ask any questions.Ìý The module will include a career forum to help students engage with careers opportunities in the pharmaceutical industry.

´¡¾±³¾²õÌý

To introduceÌýstudents to the various aspects related to industrial pharmacy.Ìý

Module learning outcomes

By the end of the module, it is expected that students will be able to:

1. Develop knowledge and understanding of a range of analytical testing, including in-vivo and in-vitro testing
2. Outline the principles of drug development from a pharmacological and biopharmaceutical viewpoint
3. Demonstrate how knowledge of the physicochemical properties of drugs inform the development and analysis of medicinal products
4. Describe novel techniques used in drug development and formulation
5. Understand the importance and considerations of quality assurance, quality control and regulatory affairs in the development of medicinal products
6. Produce a written report in an advanced scientific style that is supported by scientific literature

Ìý

Module content

This module introduces basic concepts and general principles required by pharmacists thinking about pursuing a career in industry.ÌýÌý

The module will begin by acquainting students on how new medicines are discovered, developed and commercialised. An account of how drug development has evolved will be provided as well as a discussion of the main milestones of the process and the stakeholders involved. Discussions will then move to describing how targets, hits and leads are generated, screened and validated for development into drug products. The importance of the pharmaceutical development, and specifically pre-formulation and analytical development covering the use of different advanced instrumental techniques for quantitative and qualitative analysis of drugs, metabolites and excipients, formulation optimisation, package design and process development and scale-up, will be discussed. The main regulatory obligations of sponsors will also be presented and discussed.Ìý

The module will also provide an awareness of the types, designs and approaches used in the conduct of clinical studies, the key aspect of which is to highlight the role pharmacists and other healthcare providers play in clinical trials. The students will also be introduced to the key concepts of quality and quality assurance, such as cGMP, Quality by Design, and PAT. The aim is to demonstrate the important principle that quality is built into the product during research and development and verified through in-process controls and confirmatory tests when the product is manufactured and released to the market. The module will finish with a discussion of product launch, marketing and distribution. The principles outlined by the Good Distribution Practice as well as the challenges faced by the industry, such as counterfeit products and pricing, will be discussed at this stage.

Structure

Teaching and learning methods

The learning objectives will be met through a mixture of lectures, seminars, group work, directed private study, self-directed learning, as well as practical-based laboratory classes. Some of the lectures or tutorials will utilise a case-based learning-like approach: activities will adopt characteristics of workshops where students will engage in formative activities e.g., group work, in-class discussion. Appropriate supplementary information and reading lists will be provided and facilities for computer-aided literature searching for additional relevant materials will enable students to improve their own learning skills.Ìý

Study hours

At least 40 hours of scheduled teaching and learning activities will be delivered in person, with the remaining hours for scheduled and self-scheduled teaching and learning activities delivered either in person or online. You will receive further details about how these hours will be delivered before the start of the module.

Please note the independent study hours above are notional numbers of hours; each student will approach studying in different ways. We would advise you to reflect on your learning and the number of hours you are allocating to these tasks.

Semester 1 The hours in this column may include hours during the Christmas holiday period.

Semester 2 The hours in this column may include hours during the Easter holiday period.

Summer The hours in this column will take place during the summer holidays and may be at the start and/or end of the module.

Assessment

Requirements for a pass

Students need to achieve an overall module mark of 50% to pass this module.

Summative assessment

Penalties for late submission of summative assessment

The Support Centres will apply the following penalties for work submitted late:

Assessments with numerical marks

• where the piece of work is submitted after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for that piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of three working days;
• the mark awarded due to the imposition of the penalty shall not fall below the threshold pass mark, namely 40% in the case of modules at Levels 4-6 (i.e. undergraduate modules for Parts 1-3) and 50% in the case of Level 7 modules offered as part of an Integrated Masters or taught postgraduate degree programme;
• where the piece of work is awarded a mark below the threshold pass mark prior to any penalty being imposed, and is submitted up to three working days after the original deadline (or any formally agreed extension to the deadline), no penalty shall be imposed;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

Assessments marked Pass/Fail

• where the piece of work is submitted within three working days of the deadline (or any formally agreed extension of the deadline): no penalty will be applied;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension of the deadline): a grade of Fail will be awarded.

The University policy statement on penalties for late submission can be found at: /cqsd/-/media/project/functions/cqsd/documents/qap/penaltiesforlatesubmission.pdf

You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Formative assessment

Formative assessment is any task or activity which creates feedback (or feedforward) for you about your learning, but which does not contribute towards your overall module mark.

Formative assessment is largely based on self-directed assessment and will reinforce each of the learning outcomes of the module. These will be staff, peer, or self- assessed and will include laboratory worksheets, written and online assignments. These assessments will provide students with feedback on their achievement of the learning outcomes and prepare them for the summative assessments.Ìý

Reassessment

Additional costs