SCI09004 2016 Legislation and Regulatory Affairs for Biopharmaceuticals

General Details

Full Title
Legislation and Regulatory Affairs for Biopharmaceuticals
Transcript Title
Leg Reg Biopharma
N/A %
Subject Area
SCI - Science
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Sharon Barrett, Stephen Daly
Programme Membership
SG_SBPRO_M09 201600 Master of Science in Bioprocessing SG_SBPRO_O09 201700 Postgraduate Diploma in Science in Bioprocessing SG_SBPRO_M09 201600 Master of Science in Bioprocessing

This module is taken by Masters students in Biopharmaceutical Science. It aims to provide students with a detailed knowledge and understanding of legislation and Regulatory affairs in EU and US with a particular focus on Biopharmaceuticals and Biologics.

Learning Outcomes

On completion of this module the learner will/should be able to;


Demonstrate they have detailed knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World  and their workings.


Demonstrate they have a detailed knowledge and understanding of the ICH and regulatory harmonisations.


Integrate knowledge and understanding of the Drug development/Clinical Trial Process with the Drug approval process for both Europe and USA and evaluate relevant case studies.


Understand the Drug approval process for both Europe (centralised procedure) and USA (NDA) and the different routes (decentralised Procedure, MRP) that can be taken based on the type of drug being approved (API, Generic, New Drug)


Source and evaluate the directives and annexes currently regulating pharma/biopharma production, placing on the market, pharmaco-vigilance, PQRs, and product falsification within the EU.


Demonstrate a detailed knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.


Understand the challenges associated with manufacture of biopharmaceutical products and source and interpret current legislation relating to them.


Demonstrate a knowlege of biosimilar drugs and source and interpret the legislation associated with getting approval in the EU and USA.


Engage in and demonstrate independent learning as well as communicate effectively as an individual and as a member of a team.

Teaching and Learning Strategies

This module can be taught using a combination of face to face and on-line lectures. A range of Computer-Aided Learning (CAL) packages are also used to support this module (e.g. Moodle, Adobe Connect, Panopto, Camtasia)

Students are provided with electronic materials for self-assessment and preparation for assessments/assignments. Self-directed, student-centred, independent learning is a core aspect through completion of module coursework.


Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following:

Enquiry based Projects, Assignments/mini projects inclusing Viva/Presentation

Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions

Repeat Assessments

Students will need to liaise directly with the lecturer to determine repeat assessment outcomes based on their performance throughout the module. 

Indicative Syllabus

The following is a summary of the main topics included in this particular module:

EU institutions and EMA; The FDA and the different departments within it; Pharmaceutical legislation from development, registration to pharmacovigilance; Post Approval Changes; Relevant EUDRALEX volumes, annexes and guidelines; CEPS and Active Substance Master Files; European public assessment report availability for licensed products; Batch release requirements for biologics in Europe and USA; Biosimilar drugs and Advance Therapy Medicinal Procducts; Product Falsification. Quality By Design QBD) and Quality Assurance, Process Analytical Technology (PAT).

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
60 %
End of Semester / Year Formal Exam
40 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Continuous Assessment Multiple Choice 10 % Week 5 1,2,3
2 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 10 4,5,6
3 Enquiry Project Continuous Assessment Group Project 20 % OnGoing 9
4 Mini Project &amp:::: Viva Project Project 20 % OnGoing 1,2,3,4,5,6,7,8,9

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Exam Final Exam Closed Book Exam 40 % End of Term 1,2,3,4,5,6,7,8

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Lecture Theatre Lecture 2 Weekly 2.00
Independent Learning Library Independent Learning 7 Weekly 7.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Module Resources

Non ISBN Literary Resources

Reading material will be recommended by the lecturer based on current regulatory guidelines

URL Resources

Other Resources


Additional Information