All day
June 12, 2018 – June 13, 2018
Introduction
The EU ProSafe ‘White Paper’[1] includes recommendations that should lead to create a more solid information basis for risk assessment of nanomaterials. When implemented, the recommendations regarding REACH will improve its application in both a legal and scientific sense. One of the ‘no regret’ recommendations is on further harmonization of test methods.
As part of the Nanosafety Cluster activities and sponsored by EU project PATROLS & GRACIOUS and RIVM is organizing a workshop on harmonization of standard operating procedures (SOPs). The goal is to get these SOPs towards a CEN/ISO document or OECD Technical Guideline/Guidance Document ultimately.
Specifically, the NanoSafety Cluster partners should take the initiative to select test methods that future nanosafety projects should focus on for further development and application. The availability of harmonised and validated test methods for nanomaterials is a sine qua non for risk assessment in a regulatory context. These are needed to generate data that are reliable and comparable, and thus can be used and re-used for risk assessment and modelling the effects of nanomaterials.
This workshop aims to bring together people with hands-on experience in the tests as well as those familiar with writing SOPs in order to create and advance SOPs on a variety of topics. There will be breakout sessions where (pre) selected SOPs will be presented and discussed. Experiences will be shared, examples will be presented, lessons will be learned. Each session will deliver drafts of SOPs that can be shared within the NanoSafety Cluster and serve as the ‘golden standard’ for upcoming research. Ideally, these SOPs will also be forwarded to the institutions that can transfer them into an OECD GD/TG of CEN/ISO standard. The intermediate step is to use a modified version of the NanoImpactNet SOP template that would at least result in a NSC supported SOP.
Number of participants: 45
Who: preferably people with hands on experience in any of the areas that will be discussed
Registration: via http://tiny.cc/WSSOP2018
12 June DRAFT PROGRAMME DRAFT PROGRAMME DRAFT PROGRAMME
| 9:00 | Registration and get together with coffee/tea | ||
| 9.30 | Welcome and introduction: aim of the workshop | Flemming Cassee, RIVM | |
| 9:40 | The need for standardization in the context of risk assessment and modelling | Martine Bakker, RIVM | |
| 9:55 | What are criteria for a risk assessor to use data derived by in vitro tests? | Minne Heringa, RIVM | |
| 10:20 | What is needed to get an SOP transformed into an OECD Guidance Document or Technical Guideline | Anne Gourmelon, OECD HQ | |
| 10:45 | Break | ||
| 11:15 | What is needed to get an SOP transformed into a CEN or ISO standard? | Denis Koltsov, ISO | |
| 11:40 | The experience from NanoImpactNet project | Martin Clift, Swansea University | |
| 12:00 | General discussion: when to use what ‘template’. Pros and cons | Flemming Cassee, RIVM | |
| 12:30 | Lunch (option for lab visit ALI) | ||
| 13:30 | Break out group 1a: Sample preparation for toxicity testing - sonicator probe-calibration protocol - dispersion protocols Demonstration of their robustness - characterization in batch dispersions
Chair Keld Alstrup Jensen; rapporteur TBD | Break out group 2a: In vitro test systems: cell cultures - liver spheroid with Kupffer cell as this model (Ali Kermanizadeh) - 2 GI tract model (Roel Schins + Ali Kermanizadeh) - 3D lung model (bonus) Chair Vicki Stone; rapporteur Martin Clift | |
| 15:00 | Break | ||
continue | continue | ||
| 16:30 | Plenary reporting outcomes and discussion | ||
| 17:00 | Wrap up and Closure | Flemming | |
Drinks and finger food | |||
13 June DRAFT PROGRAMME DRAFT PROGRAMME DRAFT PROGRAMME
| 9:00 | Get together with coffee/tea | |
| 9:15 | Break out group 1b: Sample characterization in biological test systems - Tissue/cell preservation - Characterisation of deposited material, i.e. dose, particle appearance in comparison to input Anna Costa
Chair Frank vd Kammer (TBC); rapporteur TBA
| Break out group 2b: in vitro test systems read out methods - Oxidative stress/ ROS decision tree to select the most appropriate ROS assay – Matthew Boyles - Genotoxicity same and which existing test – Hedwig Braakhuis Conclusions on NP interference and discuss update paper Stone/Schins 2009[2]
Chair Shareen Doak; rapporteur Ilse Gosens |
| 10:30 | Break | |
| 10:45 | Continue | |
| 12:00 | Plenary reporting outcomes, discussion and next steps | |
| 12:30 | Lunch | |
| 13:00 -13:45 | BONUS: Lecture by Shareen Doak, Swansea University | |
| 14:00 – 17:00 | Options for future dedicated meetings/discussions (not official part of the programme) | |
More information: Flemming Cassee [flemming.cassee[a]rivm.nl]
Logistics:
The hotel of preference for the SOP workshop will be:
- Hotel de Biltsche hoek, de holle Bilt 1, in De Bilt. https://www.biltschehoek.com
From there it is a 35 minute walk to RIVM. But at the days of the workshop we will organise transport to get to the RIVM. It is sometimes cheaper to book via booking.com than using the actual hotel webpage.
- Alternatively, if you prefer to see something of Utrecht city during your stay, we recommend the NH Centre Utrecht, Janskerkhof 10, Utrecht. There is a bus stop in front of the hotel take takes you to a bus stop 5 minute walk from RIVM.
Directions
See also https://www.rivm.nl/en/Contact/Directions on how to reach the RIVM. Please make sure to bring a valid ID in order to access the RIVM campus