Course Journal Critically Reviewing the Introduction to European Regulatory Affairs Module
Prepare a Course Journal Prepare a course journal that critically reviews 7 lectures from the module . Each of the 7 lectures contributes 7% of the total mark for the portfolio of lectures.
The overall objectives of the course journal are:
To demonstrate knowledge of the overall topic of the module
Critically review each of the chosen lectures
To acquire skills in literature searching, data gathering and critical evaluation of the relevant literature
To acquire an in-depth knowledge of the laws and guidelines relating to Regulatory Affairs
To demonstrate skills of organisation and presentation of relevant information.
The course journal should be a critical discussion of the lecture and also include a list of three or more references for each of the 7 lectures.
Critical discussion of the lecture topic covering for example:
The advantages and disadvantages of the regulatory requirements
Practical implications generally or for your organisation
Any ambiguity caused by any differences or inconsistencies between different regulatory documents or geographic areas
Provide any personal opinions to include evidence-based reflection and opinion on the lecture topic
specify the word count for each critical discussion and include it on the critical review.
List of references reviewed for each lecture
The course journal should refer to relevant regulatory documents, guidelines, legal documents, and published papers. These should be from three or more high-quality references for each lecture. These will not count towards the word count and should be listed at the very end of the course journal listed under each of the 7 lectures.
Please include a contents page and list of abbreviations and number the pages.
Marking Assessment for the Course Journal
Knowledge and understanding (35%)
Understanding of content from the module including in-depth knowledge of the laws and guidelines relating to Regulatory Affairs
Relevance to the lecture topics
Critical analysis (40%)
Please list sections using the following headings.
1. The advantages and disadvantages of the regulatory requirements (10%) 2. Practical implications generally or for your organisation (10%)
3. Any ambiguity caused by differences or inconsistencies between different regulatory documents or geographic areas (10%)
4. Provide any personal opinions to include evidence-based reflection and opinion on the lecture topic (10%)
Please note that the four headings do not count towards the word count.
