QLTY06006 2019 Introduction to Regulatory Affairs

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

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

Develop an understanding of the Drug development/Clinical Trial Process with the and how it interacts with the Drug approval process for both Europe and USA.

Understand the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA

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

Communicate and explain scientific information in relation to regulatory affairs

This module can be taught using a combination of synchorous and asynchorous 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. A face to face workshop may also be included as part of the module

The assessment approach for this module will be 100% continuous employed including some of the following: Assignments, Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions

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

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. Medical device regulations (IVD directive) and role of competent authority and a notified body. CE marking. The IVD directive.