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MT5519: COMMUNICATING CLINICAL SAFETY AND REGULATION WITH INDUSTRY AND THE PUBLIC (2018-2019)

Last modified: 22 May 2019 17:07


Course Overview

The will comprise lectures, tutorials and seminars. The curriculum will provide an in-depth look at pharmacovigilance, communication with regulators and the public using examples from both first and third world countries and will include detection of adverse drug reactions; causality assessment; prevention of adverse drug reactions including correct prescribing, prevention of drug errors and promotion of rational drug use; and communication of risk-benefit information to the general public. It will also include an introduction to the commercialisation of scientific ideas in the form of Bio-Business covering the pharma industry, spin out companies, IPR and finance.

Course Details

Study Type Postgraduate Level 5
Session Second Sub Session Credit Points 15 credits (7.5 ECTS credits)
Campus None. Sustained Study No
Co-ordinators
  • Dr Mary MacLeod
  • Professor Heather Wallace

What courses & programmes must have been taken before this course?

  • Any Postgraduate Programme (Studied)

What other courses must be taken with this course?

None.

What courses cannot be taken with this course?

None.

Are there a limited number of places available?

No

Course Description

The aims of this course are to provide you with an overview of Pharmacovigilance from the perspectives of industry, regulators and health care providers. To give you some insight into the potential opportunities available for careers in Pharmacovigilance.
We will cover areas such as:

Why pharmacovigilance is necessary
Current pharmacovigilance systems available worldwide
The current requirements for good clinical practice in conducting clinical trials
Practical examples of assessing SAEs and SUSARS
The roles of a clinical research associate and a research nurse.
The role of a study sponsor
The relationships between industry, health care providers and the media.

In light of Covid-19 this information is indicative and may be subject to change.

Contact Teaching Time

Information on contact teaching time is available from the course guide.

Teaching Breakdown

More Information about Week Numbers


In light of Covid-19 and the move to blended learning delivery the assessment information advertised for second half-session courses may be subject to change. All updates for second-half session courses will be actioned in advance of the second half-session teaching starting. Please check back regularly for updates.

Summative Assessments

2000 word essay on pharmacovigilance (50%); 500 word writing for the layman (20%); Presentation on a business model (30%).

Formative Assessment

There are no assessments for this course.

Feedback

None.

Course Learning Outcomes

None.

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