--Tumorigenicity: issues and assays
· Definition of tumorigenicity for stem cell lines: use for quality control of undifferentiated cells versus safety testing for differentiated products
· What are the key requirements for QC versus safety tests?
· Challenges with tumorigenicity assays?
· What experimental models are available and which is most useful?
--Transforming DNA: issues and assays
· Is there an issue? Review history of use of blood and cell products and 'Biologicals' experience
· What qualifies evidence for absence of risk: is there existing data that demonstrates the level of risk?
· What about transforming proteins and other cell products that will be present in products?

--Comparison of requirements in different regions: consensus on minimum and maximum requirements
· Can safety be established by testing alone?
· What are the risks from donor cells, media, surface treatments, other reagents including purifying antibodies?
· Draft list of important agents
· What are the approaches for research grade cell versus clinical grade?
· How can we rely on a testing result: what process validation and test control is required ?
· Is testing all about virology? What principles need to be adopted for: Prions and other organisms?
Basic principles for safety evaluation: Development of a route map?

Donor selection:
· What are the geographical issues?
· Value of an international map of endemic microbiological issues?
· Is medical history necessary?
· How and when to collect medical histories?
· Media
· Process maps and identifying risks
· How to evaluate source of material and its processing?
· What formal certification mechanisms are available and how good are they?
· What is required for auditing suppliers?
Cell bank quality control and safety testing regimes:
· What quality standards should be adopted?
· Are there guidelines that already provide suitable models?
· How to utilise 'biologicals' and transplantation regulation in relation to use of stem cell lines?

International transfer of cells: comparison of requirements
· What are the international regulations that apply to stem cell lines for research and clinical application
· Evaluation of ethical status for transfer of a production process from one region to another
· Mutuality on informed consent?
· What secure transfer can be achieved between international regions?
· What traceability is required?

Standardization of clinical grade stem cell
· What are key issues for standardization?
· Key national and international standards?
· What is required for validation of methodologies?
· How can acceptability of a test result be established in more than one country?
· What critical control materials are required?

Remaining issues or compilation of issues and topics going into a draft guidance document
· What are the critical gaps and how might they be addressed
· Conclusion: forward plan for outputs and proposals for further international coordination