News and Events

Apr 11, 2018

Workshop on harmonization of standard operating procedures


A joined PATROLS  GRACIOUS – Nanosafety Cluster event (WG C)

12-13 June 2018, Bilthoven, the Netherlands

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.

 

 

Category: Workshops
Posted by: flemmingc

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)

 

 

 

Logistics:

The hotel of preference for the SOP workshop will be:

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

 

 



[1]https://tinyurl.com/NiP2017

[2] Stone V, Johnston H, Schins RP. Crit Rev Toxicol. 2009;39(7):613-26. doi: 10.1080/10408440903120975