GCD CA1 MSCPT FT PWB 2021

RLPB – 2021

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: 15% of the marks for this assignment With reference to the Life Cycle of a Drug

Lifecycle Stages	Relevant Regulation / Directive / Guideline / Standards
DiscoveryDevelopmentPre-clinical	. . .
4. Clinical trials	. . .
5. Marketing Approval (MA)	. . .
6. Post MA (including both API and FP manufacturing)	. . .

Identify key regulations (EU only) that apply to pharmaceutical and biopharmaceutical companies (including environmental), along with guidelines (eg ICH) and standards (eg ISO 14001, ISO 17025) throughout the full lifecycle of a product.

Part 1 to be presented in the form of a list and submitted to Moodle separately to Part 2. As this is a list of regulations etc high Turnitin returns can be expected so no limit is set for Turnitin.

Part 2: 85% of the marks for this assignment

Based on the relevant regulations, directives, guidelines and standards explain in your own words

the six terms listed below.

1. Clinical Trials

2. Marketing Authorisations in Europe

3. Pharmacovigilance

4. Quality Risk Management (QRM)

5. Falsified Medicines Regulation

6. Variations

Notes on this assignment:

There is no word limit on Part 1 of this assignment which should be submitted in the form of a table as above and as a separate document.

Max word limit for Part 2 is 12’000 and the minimum is 6’000. (excluding references).

Plagiarism, deliberate or accidental will result in a grade of “0” marks and the individual will need

to present at the school board.

Part 2 of the assignment is designed such that you must write completely in YOUR OWN WORDS. Turnitin results of > 10 will need to be re-written. You will be allowed 3 attempts to submit the assignments.

Both parts 1 and 2 to be submitted / uploaded to Moodle before midnight on Friday 17^th/December/2021.

Grading Scheme for the Assignment

Criteria Descriptor	Clarity in the identification of regulations, directives, standards and guidelines.	Great clarity in the explanation of the regulations, directives, standards and guidelines.	Great clarity in the importance of the regulations, directives, standards and guidelines.	Clarity on use of References
Weighting to total 100	15	40	40	5
70-100	Great clarity in the identification of the standards, guidelines and procedures.   Demonstrating extensive research.   Demonstrating a full understanding of the topic, siting specific regulators and situations.	Great clarity in the explanation of the standards, guidelines and procedures. Provides great examples on the application and context of the standards   Demonstrating extensive research from peer reviewed journals.   Demonstrating a full understanding and application of the standards topic, siting specific regulators and situations.	Great clarity in the importance of the standards, guidelines and procedures.   Provides great examples citing how the regulation is required and its context.   Demonstrating extensive research from peer reviewed journals.   Demonstrating a full understanding and application of the standards topic, siting specific regulators and situations.	Evidence of extensive research and comprehensive list to consider during assessment of the complaint and recognition of severity of problem with consequents     Using and quoting references.   Clear understanding of the topic.
60-69	Very good clarity in the identification of the standards, guidelines and procedures.   Demonstrating very significant research.	Very good clarity in the explanation of the standards, guidelines and procedures.   Provides very good examples on the application and context of the standards	Very good clarity in the importance of the standards, guidelines and procedures. Provides good examples citing how the regulation is required and its context.	Evidence of very good research and comprehensive list to consider during assessment of the complaint and recognition of severity of

Criteria Descriptor	Clarity in the identification of regulations, directives, standards and guidelines.	Great clarity in the explanation of the regulations, directives, standards and guidelines.	Great clarity in the importance of the regulations, directives, standards and guidelines.	Clarity on use of References
Weighting to total 100	15	40	40	5
	Demonstrating a full understanding of the topic, siting specific regulators and situations.	Demonstrating extensive research from peer reviewed journals. Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.	Demonstrating extensive research from peer reviewed journals. Demonstrating a full understanding and application of the standards topic, siting specific regulators and situations.	problem with consequents.   Very good clarity in understanding the topic
50-59	Good clarity in the identification of the standards, guidelines and procedures.   Demonstrating very significant research.	Good clarity in the explanation of the standards, guidelines and procedures.   Provides very good examples on the application and context of the standards	Good clarity in the importance of the standards, guidelines and procedures.   Provides good examples citing how the regulation is required and its context.	Evidence of good research and good list to consider during the assessment of the complaint and recognition of severity of problem with consequents
	Demonstrating a full understanding of the topic, siting specific regulators and situations.	Demonstrating a good level of research from peer reviewed journals.	Demonstrating a good level of research from peer reviewed journals.	Good clarity in understanding the topic.
		Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.	Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.

Criteria Descriptor	Clarity in the identification of regulations, directives, standards and guidelines.	Great clarity in the explanation of the regulations, directives, standards and guidelines.	Great clarity in the importance of the regulations, directives, standards and guidelines.	Clarity on use of References
Weighting to total 100	15	40	40	5
40-49	Reasonable clarity in the identification of the standards, guidelines and procedures.   Demonstrating some level of research.   Demonstrating a limited understanding of the topic, siting specific regulators and situations.	Reasonable clarity in the explanation of the standards, guidelines and procedures.   Provides some good examples on the application and context of the standards but could be better. Demonstrating a reasonable level of research from peer reviewed journals. Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.	Reasonable clarity in the importance of the standards, guidelines and procedures.   Provides reasonable examples citing how the regulation is required and its context. Demonstrating a good level of research from peer reviewed journals. Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.	Evidence of reasonable research and reasonable list to consider during assessment of the complaint and recognition of severity of problem with consequents   Reasonable clarity in understanding the topic.
31-39	Poor clarity in the identification of the standards, guidelines and procedures.   Demonstrating very limited level of research.   Demonstrating very limited understanding of the topic, siting specific regulators and situations.	Poor clarity in the explanation of the standards, guidelines and procedures.   Provides some poor examples on the application and context of the standards but could be better.   Demonstrating a poor level of research from peer reviewed journals.	Inadequate and Poor clarity in the importance of the standards, guidelines and procedures.   Provides inadequate examples citing how the regulation is required and its context.   Demonstrating a poor level of research from peer reviewed journals.	Evidence of poor research and poor/limited list of considerations during the process assessment of the complaint and recognition of severity of problem with consequents   Poor/little clarity in understanding the topic.

Criteria Descriptor	Clarity in the identification of regulations, directives, standards and guidelines.	Great clarity in the explanation of the regulations, directives, standards and guidelines.	Great clarity in the importance of the regulations, directives, standards and guidelines.	Clarity on use of References
Weighting to total 100	15	40	40	5
		Demonstrating a good understanding and application of the standards topic, siting specific regulators and situations.	Demonstrating a poor understanding and application of the standards topic, siting specific regulators and situations.	Elements of ‘cut and paste’ evident in the explanation.
0-30	Poor/no clarity in the identification of the standards, guidelines and procedures.   Demonstrating extremely/no level of research.   Demonstrating no understanding of the topic, siting specific regulators and situations.	Poor/no clarity in the explanation of the standards, guidelines and procedures.   Examples are very limited and possibly not relevant.   Extensive evidence of Cut and Paste in the assignment. Turnitin similarity is above 25% and warrants investigation.	Evidence of no understanding of the importance of the regulations and guidelines.   Showing no understanding of the task/topic.   Elements of ‘cut and paste’ evident in the explanation.	No evidence of research and lack of list of considerations during the process of assessment of the complaint and recognition of severity of problem with consequents   No clarity in understanding the topic.   Elements of ‘cut and paste’ evident in the explanation.