1. 29th August,2011 EUROTOX 2011 Congress Paris, France 1 THE CURRENT POSITION OF EUROTOX REGISTRATION/ERT SYSTEM Mumtaz Iscan, Ph.D., ERT Professor of Toxicology, Department of Toxicology, Faculty of Pharmacy, Ankara University Ankara-Turkey

2. 29th August,2011 EUROTOX 2011 Congress Paris, France 2 Introduction EUROTOX Reg/ERT Sub Comm. 2009-2012 Brief information on ERT Registration procedures (Guidelines for registration of ERTs, and National Register establishment and application to EUROTOX) ERTs: promotion, publicising and other activities ERT: Nos, as of August, 2011 National Registers (15): progress in New EUROTOX registers? Annual new entries, re-registrations and deletions EUROTOX Registers Distribution of ERTs among member societies with register as of August 2011.

3. 29th August,2011 EUROTOX 2011 Congress Paris, France 3 EUROTOX Registration/ERT SubCommittee (2009-2012) Mumtaz Iscan (Chair, Turkey) Corrado Galli (Italy) Heidi Foth (Germany) Jyrki Liesivouri (Finland )

4. 29th August,2011 EUROTOX 2011 Congress Paris, France 4 The European Registration of Toxicologists is a service of EUROTOX for Toxicology and for individual toxicologists who excel by high standards of education, skills, experience, and professional standing. These toxicologists, upon application, should be certificated as EUROPEAN REGISTERED TOXICOLOGIST (ERT).

5. 29th August,2011 EUROTOX 2011 Congress Paris, France 5 In principle, In a first step, National Registration boards in Europe evaluate applications of candidates according to a consensual process and admit successful applicants to the national register. In the second step, upon request, EUROTOX will certificate these individuals as ERT without further evaluation.

6. 29th August,2011 EUROTOX 2011 Congress Paris, France 6 Obviously, the proper function of this system depends on a high degree of harmonization of standards among the registering national boards.

7. 29th August,2011 EUROTOX 2011 Congress Paris, France 7 The EUROPEAN REGISTERED TOXICOLOGIST (ERT) Guidelines for Registration The present Guidelines for Registration is an update of the “Expectations of a EUROPEAN REGISTERED TOXICOLOGIST” first published by EUROTOX in 1995. This first description of common requirements and regulations for registration of toxicologists in Europe was derived by harmonization of three founder schemes (Germany, Netherlands, United Kingdom, 1994). The “Guidelines for Registration” accommodate scientific and conceptual progress in Toxicology in the years passed and experience made with the existing registration schemes.

8. 29th August,2011 EUROTOX 2011 Congress Paris, France 8 A. Theoretical curriculum B. Practical curriculum C. Implementation of registration D. Maintenance of Registration (Re- Registration) E. The National Registering Body F. Tasks to be undertaken by the lead body (EUROTOX) The EUROPEAN REGISTERED TOXICOLOGIST (ERT) Guidelines for Registration

9. 29th August,2011 EUROTOX 2011 Congress Paris, France 9 Theoretical curriculum/programme Purpose: Theoretical training in toxicology, with associated practical working to re- enforce concepts, is essential. Such training can be provided on a modular basis and should embrace at least the topics that are defined in. 13 obligatory and 2 out of 9 elective modules/courses are obligatory for registration. Modules are completed by examinations

10. 29th August,2011 EUROTOX 2011 Congress Paris, France 10 Scheme of the Training/Education programme for ERT (Modified from Dutch Tox. Education Programme www.toxcourse.nl)

11. 29th August,2011 EUROTOX 2011 Congress Paris, France 11 B. Practical curriculum Practical experience and training must be related to Toxicology and should be based on laboratory, computer-assisted or regulatory work in one of the areas of the programme. Practical awareness During a period of not less than 5 years a candidate for Registration will be expected to have obtained Practical Awareness (knowledge of major techniques and their merits and limitations, not necessarily hands-on experience) in the topics listed. In addition an in-depth knowledge and experience will be expected in at least two of them.

12. 29th August,2011 EUROTOX 2011 Congress Paris, France 12 Documentation of practical experience, Communication skills, Authorship Candidates for registration will have documented their practical experience by at least 5 publications, confidential reports or assessments. It is regarded as essential that these papers demonstrate a high standard of critical ability and communication skills. Publications should have appeared in peer-reviewed scientific journals. Reports and assessments should be suitable for submission to regulatory agencies or for regulatory decision making.

13. 29th August,2011 EUROTOX 2011 Congress Paris, France 13 C. Implementation of registration In order to be qualified for Registration, candidates have to demonstrate their current active professional participation in the field of Toxicology. They must submit to the registering body: 1. A CV containing relevant information such as details of scientific education, of post(s) held and of professional activities performed. 2. Documentation of academic education before commencing training (entry level knowledge-base) 3. Minimum accomplishments during training (applied knowledge- base) 4. Recommendation letters should be submitted from two eminent toxicologists who are familiar with ERT requirements and the applicant’s background

14. 29th August,2011 EUROTOX 2011 Congress Paris, France 14 D. Maintenance of Registration (Re-Registration) On a 5-yearly basis, As a minimum, to remain registered, a candidate must be working as a toxicologist, and must submit the following: An updated CV containing relevant information such as details of post(s) held and of professional activities performed during the past 5-year period of registration. Documentation/Confirmation of professional toxicological activity in responsible position by evidence such as list of publications, list of other studies (with information on numbers, topics, methods used, branch of customers), employment references, delegation into expert committees, teaching and mentoring.

15. 29th August,2011 EUROTOX 2011 Congress Paris, France 15 E. The National Registering Body A participating registering body will have lodged (and had accepted) its criteria for registering toxicologists with an appropriate national body (e.g. society of toxicology). The national society in turn, will have lodged (and had accepted) these criteria with EUROTOX. One registering body only is accepted per country. The national registry will notify significant changes of their criteria to the EUROTOX Registration Subcommittee. Criteria of a participating registering body - Legislative Aspects (= application) - Executive Aspects (= evaluation) - Judicial Aspects (= appeal)

16. 29th August,2011 EUROTOX 2011 Congress Paris, France 16 F. Tasks to be undertaken by the lead body (EUROTOX) 1- Training 2- Registration

17. 29th August,2011 EUROTOX 2011 Congress Paris, France 17 1. Expected minumum criterias and other detailed documents-syllabus are provided under “Guidelines for Registration of EUROPEAN Registered Toxicologists- ERTs. 2. A template for the application and evaluation forms 3. An example for the National Register Rules for ERT. THE NECESSSARY DOCUMENTS THAT ARE SENT TO THE MEMBER SOCIETY WHO WANT TO LAUNCH ITS NATIONAL REGISTER AND APPLY FOR EUROTOX ERT SYSTEM

18. 29th August,2011 EUROTOX 2011 Congress Paris, France 18 The process of submission of a National Register to EUROTOX for approval The proposal has to be submitted to the EUROTOX Registration /ERT SubCommittee (chair) for the evaluation. After reviewing the proposal SubCommittee may require some changes before recommending the National Register proposal to EUROTOX EC for approval.

19. 29th August,2011 EUROTOX 2011 Congress Paris, France 19 Maintenance of the EUROTOX European Register is carried out by EUROTOX SECRETARIAT (Currently by Ellaine Ferioli in Milan-ITALY)

20. 29th August,2011 EUROTOX 2011 Congress Paris, France 20 EUROTOX REGISTRATION / STANDARD OPERATING PROCEDURES (SOP) Maintenance of the EUROTOX European Register, as follows: Liaison with National Register link people concerning new registrations, re-registrations and deletions to the European Register, via e-mail. Change the European Register database on receipt of information concerning the above from National Register Link people. Typing certificates and filing copies of new members. Sending certificates to National Register link people for distribution, together with receipts and return addressed envelopes. New members then send back the receipts, which are then filed, alphabetically by country, with the copy certificates. Deal with any queries arising from liaison with National Register link people, forwarding them to chair of EUROTOX Registration/ERT SubCommittee where necessary. On a six-monthly basis: Send information on the number of new members to chair of EUROTOX Registration/ERT SubCommittee. On an annual basis: Notification to the EUROTOX Treasurer of the number of new members each year, by country, for billing purposes. Sending current National Register listing of information on the European Register to each National Register link person to check for any changes, or data that may have “slipped through the net” during the year (eg. Re-registrations or deletions). EUROTOX/SOP – Standard Operating Procedures – Operated by EUROTOX Secretariat

21. 29th August,2011 EUROTOX 2011 Congress Paris, France 21 Promotion and Publicising activities (1) Promotion and recognition of ERT certification continued in the CTDC meeting in Sun City. IUTOX 7th Congress of Toxicology in Developing Countries held in Sun City, South Africa on September 6-10, 2009, EUROTOX held the session followed by a round table discussion entitled "Harmonisation of Toxicology issues between developed and developing countries". The program and the presentations of the speakers are available on the EUROTOX web page.

22. 29th August,2011 EUROTOX 2011 Congress Paris, France 22 Promotion and Publicising activities (2) A Workshop is held on 29th of August 2011 in EUROTOX 2011 Paris Congress. The title of Workshop is “The EUROTOX Registration/ERT System; Present Position and Objectives” The ERT poster and the brochures are displayed in EUROTOX booth and the brochures are distributed to the participants during the EUROTOX Congresses.

23. 29th August,2011 EUROTOX 2011 Congress Paris, France 23 Officially recognition of ERTs (1) Based on the numerous interest/applications of toxicologists working in industry and as consultants all around the world for ERTs, the credibility of ERTs is increasing world wide. Recently ECHA in their job advertisement/opportunity considered ERT as one of the assets. These are big encouraging developments in the awareness of ERTs among the stakeholders and signs of increasing job opportunities of ERTs. However, although these are good signs, this is not adequate and as EUROTOX we need to explore/broaden and make ERTs formally/ officially recognised by all stakeholders.

24. 29th August,2011 EUROTOX 2011 Congress Paris, France 24 Officially recognition of ERTs (2) The similar need was also reported at the EUROTOX Registration Strategy plan Meeting during IUTOX Congress in Barcelona, 2010. Moreover, the official recognition of ERTs have been questioned by our member societies over the years and thus some of them were reluctant to be part of our ERT System since it does not provide any benefit to the members of their societies. This was also encountered in the recent IUTOX Survey which was conducted for the purpose of global harmonisation of existing registration and certification of toxicologists schemes under the umbrella of IUTOX. Hence, based on the aferomentioned reasons, RSC and ESC at their joint meeting decided to give a proposal to EUROTOX EC to establish a task force (composed of few members of RSC and ESCs and reinforced with the individuals from EU authorities and industry) to work and lobby actively for official/formal recognition of ERTs by stakeholders such as regulatory bodies, organisations and others in Europe and thus strengthen its important mission which is being the voice of Toxicology in EUROPE.

25. 29th August,2011 EUROTOX 2011 Congress Paris, France 25 Other activities Registration SubCommittee and Education SubComittee had a joint one full day meeting on 10th of January in Stockholm, Sweden, 2011 to up-date the ERT-Syllabus, discuss the education requirements for ERT, education and the current levels of education and training, the current activities related to ERTs and other related matters; The outcome/decisions of this meeting were as follows; -ERT-syllabus (Guidelines for ERT registration) was updated and modernized. -Submission of a proposal to EUROTOX EC to establish a tentative Task Force to work and lobby actively for official recognition of ERT. -Some other decisions concerning the current levels of education and training of toxicologists and the proposal to EUROTOX EC for support of educational activities. The next joint meeting is going to be held in 6 months to - Discuss the unfinished issues/items of the agenda of Stockholm. - Follow-up of the decisions taken in the previous meeting (Stockholm). - Discusss the new emerging issues.

26. 29th August,2011 EUROTOX 2011 Congress Paris, France 26 IUTOX Related activity IUTOX Registery project (1) IUTOX initiated a task for the global harmonisation of existing registration and certification of toxicologists schemes under the umbrella of IUTO. For this purpose IUTOX formed the Toxicology Recognition Task Force (TRTF) in 2011. EUROTOX has been invited to participate in this Project by being the member of TRTF. Since then EUROTOX President and RSC participated in all meetings and conference calls held by IUTOX as member of the TRTF. The information about the recent IUTOX member Society surveys and below proposed/recommended plans of IUTOX were given to the participants and these were thoroughly discussed. Briefly IUTOX developed two-part international toxicology recognition plan after considering the data derived from the recent IUTOX Member Society survey where 90% of respondents stated they are in favor of a toxicology recognition scheme. Part I Development of a Global Directory of Toxicology, to record the names of toxicologists around the world who currently participate in a national or regional toxicology society (this would rely on the cooperation of IUTOX Member Societies to either nominate or approve individuals for inclusion in the directory..

27. 29th August,2011 EUROTOX 2011 Congress Paris, France 27 IUTOX Related activity IUTOX Registery project (2) Part II Harmonize certifications and registries that already exist in countries or regions for senior scientists. This is a longer term objective due to the level of coordination that will be required between groups in Europe (ERT) Japan and the United States. –Next meeting –Paris, EUROTOX Meeting August 2011-With regard to the Global Directory, the following issues are going to be resolcved; Opt in/opt out of the Directory by individual toxicologists, the responsible individual/s collecting the data and maintain it, determine administrative costs associated with the Directory, funding, evaluate the possible revenues needed to produce and maintain the Directory. Part II: The plan is that the discussions about the harmonization process get underway in Paris and be completed by the ICTXIII meeting in Seoul, 2013.

28. 29th August,2011 EUROTOX 2011 Congress Paris, France 28 ERTs 2011 ERTs 2011 Nos. at 1st of August, 2011 = 1438

29. 29th August,2011 EUROTOX 2011 Congress Paris, France 29 Annual number of new entries re-registrations and deletions for Eurotox Registration during the recent years Annual number of new entries re-registrations and deletions for Eurotox Registration during the recent years New members : 80 - 120 Re-registrations : 40 - 60 Deletions : 10 - 20

30. 29th August,2011 EUROTOX 2011 Congress Paris, France 30 Progress in New EUROTOX registers Progress in New EUROTOX registers Bulgaria : Application received. Evaluated and accepted by the Registration/ERT SubCommitee after revision. Submitted to EUROTOX EC with recommendation its approval in May, 2011. The decision/approval of EUROTOX EC is expected during EUROTOX Paris Congress.

31. 29th August,2011 EUROTOX 2011 Congress Paris, France 31 Status of the ERT register (2011) Status of the ERT register (2011) Societies in EUROTOX 31 Societies with a register 15 Registered toxicologists 1438 Registered toxicologists vs. EUROTOX members 19.97 %

32. 29th August,2011 EUROTOX 2011 Congress Paris, France 32 National Registers and their foundation years (and pending one) National Registers and their foundation years (and pending one) Austrian 1998 Belgian 2010 (Bulgaria)Dutch 1990 Finnish 1998 French 1996 German 1988 Hellenic 2010 Irish 2005 Italian 1999 Norwegian 2001 Polish 2006 Spanish 2001 Swiss 1998 Turkish 2007 UK 1994

33. 29th August,2011 EUROTOX 2011 Congress Paris, France 33 Distribution of the ERTs among the Societies with a register ( % of total -1438 ) Distribution of the ERTs among the Societies with a register ( % of total -1438 ) Austrian 1.32 Belgian 2.16 (Bulgaria) Pending Dutch 20.31 Finnish 2.43 French 11.40 German 13.84 Hellenic 0.63 Irish 0.97 Italian 3.55 Norwegian 4.87 Polish 1.95 Spanish 4.73 Swiss 9.53 Turkish 1.25 UK 21.07

34. 29th August,2011 EUROTOX 2011 Congress Paris, France 34 THANK YOU.