Resources
Guidelines for the Transport, Storage and Disposal of GMOs
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
There are Guidelines for the Transport, Storage and Disposal of GMOs.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Stability Testing Of New Drug Substances and Products Q1A(R2)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Evaluation for Stability Data Q1E (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
European Commission: Enterprise and Industry Directorate-General. Definition of a Investigational Medicinal Products (IMPs) Definition of Non Investigative Medicinal Products (NIMPs)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
Directive 2001/20/EC of the European Parliament and of the Council
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
Reducing the Potential for Mistakes With Investigational Drugs (Website)
Routine practices that are used to name, label, package, and store investigational drugs have raised serious concerns about patient safety.
Microdevices that mimic human organs could replace animal testing (Video)
Human Organs-on-Chips by the Wyss Institute at Harvard University was crowned Design of the Year 2015 this week. In this movie, scientist Tony Bahinski explains how the chips could one day replace animal testing.
Animal Ethics Infolink (Website)
This resource is to complement your learning, and introduce you to other perspectives on the topics under discussion.
This website has been developed by the Animal Research Review Panel and NSW Department of Primary Industries - Animal Welfare Branch. It aims to assist researchers, teachers and members of Animal Ethics Committees to access information about the operation of the Animal Research Act 1985, Animal Research Regulation 2010 and The Code of Practice in New South Wales.
Ethical review of the use of animals in research: a reflection on the journey
It is nearly forty years since the first committees were established to review the ethical acceptability of research using animals. Modelled on comparable committees concerned with human subjects, the establishment of animal ethical review committees recognized that such activities presented ethical challenges and that, given the level of controversy in the wider community, scientists needed to demonstrate responsibility and accountability for their actions. These committees now have been established in many countries, albeit with differences in their charter and standing; in some countries, the role of the committee is mandated in legislation. There have been few reviews into the operation of animal ethical review committees, but available evidence raises questions as to the outcomes of the ethical review process and effective engagement with the wider community. The ethical review process would be strengthened by reflection upon and reaffirmation of expected goals and a better understanding and recognition of the broader context within which a committee operates.
Australian code for the care and use of animals for scientific purposes (Website)
The purpose of the Australian code for the care and use of animals for scientific purposes 8th edition 2013 (the Code) is to promote the ethical, humane and responsible care and use of animals used for scientific purposes. The ethical framework and governing principles set out in the Code provide guidance for investigators, teachers, institutions, animal ethics committees and all people involved in the care and use of animals for scientific purposes.

