Past events & courses

GMP requirements are rooted in strict, non-negotiable legislation while biosafety relies on the nuanced art of risk assessment. These two domains share significant synergies but also harbor conflicts. Misalignment between GMP and biosafety standards can lead to facilities that fail to fully comply with biosafety, compromising containment design, improper airflow management, and increasing risk of carry-over of contamination and release.

It is known that human reliability and behaviour have a major impact on an individuals ability to work safely in a laboratory; and yet these same factors can be overlooked when assessing the risks in that laboratory. This pre-conference course will take your risk assessments to the next level through ensuring that human reliability is accounted for in risk assessments and introduce the concept of safety critical task analysis. This pre-conference course is aimed at those individuals who are already risk assessors or understand the risk assessment process and provide attendees with the skills and knowledge to complete safety critical task analysis. It will not only consist of theory sessions on risk assessment and human reliability but also a visit to teaching laboratories at ITM and so taking the biological risk assessment process from paper to practice.

After presenting the major risks encountered when working with insects that may carry pathogens or parasites, the course will address the characteristics of laboratories dedicated to their containment (ACL1-3). In addition to the structural elements of these specialized laboratories, the course will also describe best practices and appropriate protective equipment to use. The presentation will be completed by a visit to an ACL. Participants will also be involved in an interactive exercise (carried out in groups of 3-4 participants) of risk assessment for the proposed study cases.

There are a variety of investigational human and veterinary medicinal products consisting of or containing GMOs. GMOs for human medicines may include the following: human cells modified ex vivo; vaccines; recombinant virus-based vectors, including those containing genome editing nucleic acid sequences (which may also be delivered non-virally) and bacterial vectors.Medicinal products based onmRNA are on the rise. One need to define which constructs are still GMOs or not, which constructs are less or more hazardous than the wildtype virus, they are derived from, and which might serve as agent to harm others. How are people and the environment protected when they are widely used, also outside controlled laboratory settings. There is guidance and regulation. Which ones to apply is the one hundred Euroquestions.

Essential elements of and metholodolgies to perform risk assessment Assessing the risk of biological materials (microorganisms, cells, tissues) Evaluating the risk of procedures/activities Defining measures to control/minimize the risk (containment, GMT, PPE, training)

Working with an animal model of infection means introducing an additional risk into the infection chain.   Not only the animals need to be handled appropriately to reduce a potential risk to the scientist, the equipment also plays a major role in minimising risk during individual infection experiments.  Infection models with obligate pathogenic human germs must be treated carefully and calmly. The 3Rs of laboratory animal science are not only a guarantee for ethically sound experiments, but also serve the safety of the researchers.  This course is rated as advanced. Therefore basic knowledge of Biosafety is a prerequisite as well as initial knowledge in working with animals.

Waste management is a topic of interest to all facilities who manage biological agents, no matter how large or small, private or public; but mostly it is not seen as a very exciting or sexy topic.Check out the details for this course

The course will include a site visit.