About Pre conference course C. Risk assessment for GMO (specialized) cloning, viral and non-viral vectors
Pre conference course C. Risk assessment for GMO (specialized) cloning, viral and non-viral vectors
Ursula Jenal and Myra Widjojoatmodjo
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.
All these issues are addressedin this course with a wealth of examples and experience in the field of biological risk assessment for laboratories, environmental risk assessment for clinical trials and management plans for market application.
Active participation in discussions and working groups are expected. Questions of participants will be collected, and the trickiest questions will be awarded.
Biosafety and biosecurity of recombinant virus and viral vectors
- Characteristics of different types of recombinant virus and viral vectors and their hazards
- Characteristics of virus-derived constructs and non-viral DNA- or RNA based-constructs and their hazards
- Hazards related to attenuation and gain of function of viral constructs
- Minimizing hazards using latest technologies in biological research
- Exposure risks in research laboratories
GMOs in clinical trials and marketing authorization
- EU GMO framework differently implemented across EU countries
- Harmonization efforts by EMA (e.g. harmonized GMO documents)
- Navigation through the EU GMO framework to initiate multi-country clinical trials
- Environmental risk assessments for EU clinical trials and market application
- GMO legal framework outside EU
The workshop is suitable for all interested in discussion potential risks related to the recombination of viruses and virus-based constructs because of their involvement in managing these risks related to people working in laboratories, administering them to patients in clinical applications or addressing them with regulatory bodies for market application.
Participants will be able to ask the relevant questions to distinguish the hazards of different viral constructs and how these translate to risk to people or the environment. They will be able to understand the issue of whether a construct falls under the GMO regulation and not. They will be able to manage risks in situations such as application of gene therapy products in clinical settings or in home-based circumstances. Also, they will be able to define when biosafety and biosecurity measures have to be implemented. Finally, they will have an understanding of the relevant internationally recognized guidance documents.
CWA 16335:2011, annex C reference
The course presents the general importance and essential principles of section 7.2.1 to 7.2.15, except 7.2.9 and 7.2.10, when work with virus and viral vector is concerned and in particular Annexes
- C.220.127.116.11 general principles of molecular biology and genetic engineering,
- C.18.104.22.168 general principles of environmental safety,
- C.22.214.171.124 international regulatory framework, standards, guidelines and conventions,
- C.2.2.10 gene therapy activities