RLPB – 2023 This is your First Assignment that counts for 50% of your overall marks for this module. There are two parts to this assignment Part 1: 80 % of the marks for this assignment. (Submit as a Microsoft Word document ONLY).
Introduction: European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.
In your own words: 1. Research and Summarise the history of Clinical Trials in the EU leading up to the introduction of the above regulation. 2. Summarise the requirements of the new Clinical Trials Regulation. 3. Referencing your research discuss whether in your opinion the new Regulations go far enough to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparicyalsaftifor clinical trial participants
Part 2: 20 % of the marks for this assignment (submit preferably as Microsoft PowerPoint) 1. Prepare a short (max 10 slides / pages / poster) on your research into Clinical Trials in the EU. You will be expected to make a short presentation to your tutor.
Notes on this assignment: Max word limit for Part 1 is 6’000 words. (excluding references). Plagiarism, deliberate or accidental will result in a grade of “0” marks and the individual will be at risk of disciplinary actions from the college.
Part 2 of the assignment is designed such that you can explain your approach to your research and your findings.
Turnitin results of > 15 will need to be reviewed. You will be allowed 3 attempts to submit the assignments.
Both parts 1 and 2 to be submitted / uploaded to Moodle before midnight on
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