LAW08013 2019 Pharmaceutical Legislation

Demonstrate a detailed knowledge and understanding of the US and EU institutions, legal instruments, ICH process and workings of the EMA and FDA.

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

Integrate knowledge and understanding of the marketing authorisation process, the variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

Interpret EUDRALEX Volume 2 / ICH M4: ‘Notice to Applicants’ documentation to allow presentation of module contents to peers.

Examine and evaluate Irish legislation pertaining to pharmaceutical products.

Demonstrate a knowledge of current Medical Device regulations/directives and notified bodies.

This module will be delivered full time. This will include lectures, augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).

This module is 100% Continuous Assessment.

The continuous assessment and course work will involve several assignments/case studies where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area.

formative assessment - Self-assessment tests and other forms of formative assessment are provided to students to check their own progress towards achieving the learning outcomes of the module and to motivate learning.

Repeat Continuous Assessment.

1.  Demonstrate a detailed knowledge and understanding of the US and EU institutions, legal instruments, ICH process and workings of the EMA and FDA.

Development of Regulatory Affairs, Definitions, Regulatory framework - Directives/Regulations.

Expansion on EU – EMA, US - FDA, European & US legislation and terminology, Licenses required.

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

European Registration Process. EMA. Responsibilities of MAH, Manufacturer/QP.

Summary of Product Characteristics and Variations and PQR, unique identifier, registration database and internet sales, PSURs.

3. Integrate knowledge and understanding of the marketing authorisation process, the variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

EMA authorisation processes, Clinical Trial Legislation. EUDRACT.

4. Interpret EUDRALEX Volume 2 / ICH M4: ‘Notice to Applicants’ documentation to allow presentation of module contents to peers.

CTD, Quality, Pre-Clinical, Clinical Data and presentation.

5. Examine and evaluate Irish legislation pertaining to pharmaceutical products.

Irish Pharmaceutical Legislation (SI’s).

Principal Regulatory Affairs authorities (Competent Authority)  UK/Ireland.

6.  Demonstrate a knowledge of current Medical Device regulations and directives and notified bodies.

EU directives/regulations that instruct regulation of medical devices and explain the three main types of medical device under these directives.

Classification of medical devices according to EU and Irish legislation and differentiate between the levels of risk associated with medical device classes.