ICH Q10 Pharmaceutical Quality System, Essay Assignment, EMA, Ireland

(Bio) PQS Assignment #1

This assignment is worth 25% of module marks. The assignment should be uploaded to moodle no later than 6pm Friday 15^th November 2024.

The assignment consists of 2 parts- an essay and a presentation.

BOTH PARTS OF THE ASSIGNMENT ARE MANDATORY.

Word count expectation for the essay is between 2500 and 3000 words

Marking scheme outlined on page 3.

Don’t forget to include declaration below and put your name on your assignment. Put the declaration at the start of the essay.

Upload essay and presentation to turn-it-in area in moodle- Essay in Word or PDF format, Presentation in PPT or mp4 format

Essay Brief:

Discuss the importance of the ICH Q10 Pharmaceutical Quality System in making safe and effective medicines available for patients. (15%)

Presentation Brief:

Prepare and record a 5-6 minute (approx.) PPT presentation outlining the key points from your essay (10%)

Include this declaration at the start of your essay:

By inserting & signing my name below, I declare that my essay/report, which I now submit for assessment is my own work and that any assistance I received in undertaking this work is fully acknowledged and disclosed in the document. I confirm that the Project was completed by me during the academic term that I was a student of IT Sligo.

Assignment marking will be based on the following:

Quality and depth of content/ evidence of good research 25%

Assignment demonstrates a clear understanding of GMP requirements 25%

Writing  is supported by clear examples/ figures/ visuals 15%

Writing style, grammar, structure, and presentation of essay 15%

Range of sources/ Quality of referencing 20%

Presentation:

Quality of slides/ Professional/ Effort/ Appearance 25%

Information on slides 25%

Ability to condense key points and meet time requirements 25%

Presentation skills  25%