BIO09005 2019 Legislation and Regulatory Affairs

Demonstrate they have detailed knowledge and understanding of the global regulatory framework for biotechnology derived products

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

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

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.

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

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

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.

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.

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

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).