BIO09005 2019 LEGISLATION AND REGULATORY AFFAIRS

General Details

Full Title
LEGISLATION AND REGULATORY AFFAIRS
Transcript Title
LEGISLATION AND REGULATORY AFF
Code
BIO09005
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Stage
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Stephen Daly
Programme Membership
SG_SBIOP_E09 201900 Level 9 Certificate in BioPharmaceutical Science SG_SBIOP_M09 201900 Master of Science in Biopharmaceutical Science SG_SBIOP_O09 201900 Postgraduate Diploma in Science in Science in Biopharmaceutical Science
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 global regulatory framework for biotechnology derived products

2.

Source and interpret EUDRALEX Volume 2 - "Pharmaceutical Legislation : Notice to Applicants for Medicinal Products".

3.

Intergrate knowledge and understanding of the drug development/clinical trial process with the drug approval process for EU and USA

4.

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.

5.

Evaluate the nature and production of biotechnology derived product and how these have a regulatory impact for quality, safety, and efficacy.

6.

Formulate and communicate judgements with regard to regulatory issues for biopharmaceutical products.

Teaching and Learning Strategies

This module will be taught using 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 including Viva/Presentation
Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions.

Repeat Assessments

Students will have opportunities to re-submit work  as agreed with their lecturer.

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; The ICH and the CTD.

Pharmaceutical legislation from drug development, registration to pharmacovigilance; Post Approval Changes;

European public assessment report availability for licensed products;

Relevant EUDRALEX volumes, annexes and guidelines;

The roles of the Marketing Authorisation Holder, Qualified Person, Qualified Person for Pharmacovigilance, Responsible Person.

CEPS and Active Substance Master Files; Product Falsification.

Batch release requirements for biologics in Europe and USA;

Biosimilar drugs and Advance Therapy Medicinal Procducts;

Quality By Design QBD) and Quality Assurance, Process Analytical Technology (PAT).
 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

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 9 4,5
3 End of Semester Assessment Continuous Assessment Assessment 20 % Week 12 1,2,3,4,5
4 Project and Viva Project Individual Project 40 % Week 12 6
5 Gp Project Project Project 20 % Week 11 6

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

Required & Recommended Book List

Required Reading
2007-08-13 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9780470012444 ISBN-13 0470012447

Offers a comprehensive introduction to the principles and concepts of pharmaceutical biotechnology.

Module Resources

Non ISBN Literary Resources

See booklist

Journal Resources

Pharmaceutical Drug Regulatory Affairs Journal

URL Resources

www.FDA.gov

https://www.ema.europa.eu/en

www.hpra.ie

www.ich.org

https://ec.europa.eu/health/documents/eudralex_en

https://www.edqm.eu/

 

 

Other Resources

None