BIO09005 2008 LEGISLATION AND REGULATORY AFFAIRS
Full Title
LEGISLATION AND REGULATORY AFFAIRS
Transcript Title
LEGISLATION AND REG AFFAIRS
Code
BIO09005
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
ASCI - Applied Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
€
Start Term
2008 - Full Academic Year 2008-09
End Term
2019 - Full Academic Year 2019-20
Author(s)
Mary Butler
Programme Membership
SG_SBIOP_O09 200900 Postgraduate Diploma in Science in Biopharmaceutical Science
SG_SBIOP_M09 200900 Master of Science in Biopharmaceutical Science
SG_SBIOP_E09 200900 Certificate in Biopharmaceutical Science
SG_SBIOP_O09 201300 Postgraduate Diploma in Science in Biopharmaceutical Science
SG_SBIOP_E09 201300 Level 9 Certificate in Biopharmaceutical Science
SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science
SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science
SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science
SG_SBIOP_E09 201700 Level 9 Certificate in Biopharmaceutical Science
SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science
SG_SBIOP_M09 201300 Master of Science in Biopharmaceutical Science
SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science
SG_SBIOP_M09 201700 Master of Science in Biopharmaceutical Science
SG_SOSCBIOP_M09 201900 Level 9 Masters by Research
SG_SBIPR_M09 201900 Master of Science in Biopharmaceutical Processing
Description
This module is taken by Masters students in Pharmaceutical or Biopharmaceutical Science or Engineering. It aims to provide students with a detailed knowledge and understanding of biopharmaceutical legislation in EU and US. It explains the legislation applicable and guidelines available to biopharmaceutical manufacturers.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Demonstrate they have detailed knowledge and understanding of the main EU institutions, legal instruments, ICH process and workings of the EMEA.
2.
Source and interpret procedures and directives currently regulating pharmaceutical production and sales within the EU including product registration, advertising and packaging, good manufacturing, laboratory and clinical practice and pharmocovigilance.
3.
Source and interpret EUDRALEX Volume 2 - "Pharmaceutical Legislation : Notice to Applicants for Biological Medicinal Products".
4.
Source and interpret Annex 2 (Manufacture of Biological Medicinal Products for Human Use) of EUDRALEX Volume 4 - "Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice" and the 3ABx Biotechnology Guidelines, EUDRALEX Volume 3 "Medicinal Products for Human Use : Guidelines".
5.
Demonstrate they have detailed knowledge and understanding of the European public assessment report (EPAR) and understand the legal basis for its creation and availability.
6.
Demonstrate they have detailed knowledge and understanding of the requirements of Official Control Authority Batch Release (OCABR), for Human and Veterinary Biologics
7.
Demonstrate they have detailed knowledge and understanding of CDER and CBER responsibilities and biologics license application (BLA) process in USA.
8.
Formulate and communicate judgements with regard to regulatory issues for biopharmaceutical products.
9.
Demonstrate an awareness of current issues impacting biopharmaceutical industry and understand ethical and philosophical issues attached to these.
10.
Demonstrate they have knowledge of key environmental legislation, GMO and GMM legislation applicable to the biopharmaceutical industry.
Indicative Syllabus
The following is a summary of the main topics included in this particular module: EU institutions and EMEA; pharmaceutical legislation from registration to pharmacovigilance; relevant EUDRALEX volumes, annexes and guidelines; European public assessment report availability for licensed products; batch release requirements for biologics; US institutions for biologics.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQs, project assignments, practical work, essays, oral presentations, vivas etc | Coursework Assessment | UNKNOWN | 100 % | OnGoing | 1,2,3,4,5,6,7,8,9,10 |
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
| Independent Learning | UNKNOWN | Self Study | 7 | Weekly | 7.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
MHRA, Medicines and Healthcare Products Regulatory Agency (MHRA), "Rules and Guidance for Pharmaceutical manufacturers & distributors 2007" (Orange Guide)., MHRA, 2007
Other Resources
None