澳门六合彩开奖记录
BIMCB22: Commercial Biotechnology 2 $拢 Taking Drugs to Market
Module code: BIMCB22
Module provider: School of Biological Sciences
Credits: 20
Level: Postgraduate Masters
When you'll be taught: Semester 2
Module convenor: Dr Chris Jones, email: c.i.jones@reading.ac.uk
Pre-requisite module(s):
Co-requisite module(s):
Pre-requisite or Co-requisite module(s):
Module(s) excluded:
Placement information: NA
Academic year: 2024/5
Available to visiting students: No
Talis reading list: No
Last updated: 23 May 2024
Overview
Module aims and purpose
This module will introduce students to the operational processes used in the biopharma sector to bring new drugs to the market. Students will be introduced to the regulatory processes required to bring new drugs to market and will go through some of the key steps in this process such as running clinical trials, data management, pharmacovigilance, ethics and the clinical and pre-clinical research pipeline.聽 This module will give students an understanding the drug development process from drug discovery and candidate selection though to pre-clinical testing and toxicology, the principles of Good Laboratory/Manufacturing Practice, clinical trials and regulatory approval.聽聽
Module learning outcomes
By the end of the module, it is expected that students will be able to:聽
- Apply critical thinking and problem-solving skills to identify and address key challenges and risks in the drug development process.聽
- Demonstrate knowledge of the regulatory considerations involved in developing biotechnology products.聽
- Demonstrate knowledge of the different phases of clinical trials and the key considerations in designing and conducting successful trials.聽
- Critically evaluate the organisational structure of a range of biotechnology companies in the context of successfully bringing drugs to market.聽
Module content
- Regulatory requirements for drug approval.聽
- The research pipeline in biotechnology.聽
- GLP and GMP principles.聽
- Principles of clinical trial design.聽
Structure
Teaching and learning methods
Teaching will be delivered through formal lectures and seminars in which students will discuss key concepts in the drug development process with the aid of case studies provided by industry. Students will also be expected to learn through self-directed study and through group working. Learning will be assessed by an oral exam in which students will be given data and evidence from a hypothetical drug development scenario and asked to evaluate the potential future steps in the drug development and approval process.聽
Study hours
At least 34 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.
聽Scheduled teaching and learning activities | 聽Semester 1 | 聽Semester 2 | 听厂耻尘尘别谤 |
---|---|---|---|
Lectures | 22 | ||
Seminars | 12 | ||
Tutorials | |||
Project Supervision | |||
Demonstrations | |||
Practical classes and workshops | |||
Supervised time in studio / workshop | |||
Scheduled revision sessions | |||
Feedback meetings with staff | |||
Fieldwork | |||
External visits | |||
Work-based learning | |||
聽Self-scheduled teaching and learning activities | 聽Semester 1 | 聽Semester 2 | 听厂耻尘尘别谤 |
---|---|---|---|
Directed viewing of video materials/screencasts | |||
Participation in discussion boards/other discussions | |||
Feedback meetings with staff | |||
Other | |||
Other (details) | |||
聽Placement and study abroad | 聽Semester 1 | 聽Semester 2 | 听厂耻尘尘别谤 |
---|---|---|---|
Placement | |||
Study abroad | |||
聽Independent study hours | 聽Semester 1 | 聽Semester 2 | 听厂耻尘尘别谤 |
---|---|---|---|
Independent study hours | 166 |
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聽module.
Summative assessment
Type of assessment | Detail of assessment | % contribution towards module mark | Size of assessment | Submission date | Additional information |
---|---|---|---|---|---|
Oral assessment | Oral exam | 100 |
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.
Seminars will provide students with an opportunity to gain feedback on their understanding of the topics covered in the module.聽
Reassessment
Type of reassessment | Detail of reassessment | % contribution towards module mark | Size of reassessment | Submission date | Additional information |
---|---|---|---|---|---|
Oral reassessment | Oral exam | 100 |
Additional costs
Item | Additional information | Cost |
---|---|---|
Computers and devices with a particular specification | ||
Required textbooks | ||
Specialist equipment or materials | ||
Specialist clothing, footwear, or headgear | ||
Printing and binding | ||
Travel, accommodation, and subsistence |
THE INFORMATION CONTAINED IN THIS MODULE DESCRIPTION DOES NOT FORM ANY PART OF A STUDENT'S CONTRACT.