ERT. European Registered Toxicologist. SFTs årsmöte april 2014

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1 ERT European Registered Toxicologist 1

2 Vad är ERT? Toxikologer som uppfyller kraven i EUROTOX riktlinjer Human- och ekotoxikologer Start 1994 >1500 toxikologer är ERT (ca 20% av EUROTOX medlemmar) 2

3 Varför ERT? Kvalitetsstämpel Underlättar vid internationella kontakter Uppmuntrar fortbildning Konkurrensfördel vid jobb-sök Underlättar rekrytering 3 DABT Diplomat of the American Board of Toxicology

4 Dessutom. ERT växer i Europa ERT eller annan certifiering efterfrågas allt mer vid anställningar Tiotalet svenskar har sökt om ERT via Finland, fler troligen på väg 4

5 Vem bestämmer om ERT? EUROTOX riktlinjer (viss nationell anpassning) Nationella kommittéer ansvarar för bedömning Möjlighet att överklaga 5

6 ERTs riktlinjer i korthet Tox courses Practical experience Working Experience Professional Engagement Basic Degree 6

7 Utbildning i Sverige Flera svenska universitet erbjuder hela eller delar av kurskraven för ERT ERT uppmuntrar till kartläggning och synliggörande av utbildning EUROTOX listar utbildningar & kurser inom Europa som uppfyller ERTs krav 7

8 Sveriges väg mot ERT 2 internationella workshops (Sthlm 2012, Utrecht 2013) 2 nordiska möten (2013, 2014) Beslut på SFTs årsmöte 2013 att bereda underlag för ett svenskt register SFT arbetsgrupp (MHG, JZ, HK, CB, CN) Svenskt utkast på remiss 2013 Beslut på SFTs årsmöte ? 8

9 Remiss av svenska riktlinjer Remiss till: 8 företag 9 myndigheter 5 utbildare 4 organisationer 11 forskargrupper 21 studenter Totalt 58 mottagare, varav 11 svarade +Alla medlemmar i SFT 9

10 Remissvar - sammanfattning Utbildare och forskare (KI, UU miljö, UU farma, GU): Allmänt positiva, synpunkter på delmoment/praktisk erfarenhet, viktigt att hålla öppet för olika bakgrunder Industrin: AstraZeneca mycket positiva. IKEM tror på fördelar internationellt, men befarar obligatorium och ifrågasätter nyregistrering vart 5 te år. Myndigheter och organisationer: Naturvårdsverket ser obetydliga fördelar men inga nackdelar (hade missförstått att ekotoxikologer inte kan registreras). Naturvetarna positiva (ökad tydlighet kring kvalitet & behov av kompetensen och professionen, samt ökade möjligheter till internationella karriärer) Studenter/nya toxikologer: Generellt positiv respons, men viss farhåga att inte MSc skall räcka till att få jobb 10 IKEM: Innovations- och kemiindustrierna i Sverige IKEM är resultatet av en fusion mellan branschorganisationen Plast- & Kemiföretagen och arbetsgivarförbundet Industri- och KemiGruppen.

11 Årsmötesbeslut 2013 I protokollet från SFTs årsmöte 2013 står följande: Styrelsen har som målsättning att till nästa årsmöte presentera ett beslutsunderlag för om Sverige ska starta ett register. 11

12 Förslag till beslut angående ERT: Styrelsen ges i uppdrag att, utifrån det förslag på nationella riktlinjer som presenterats vid årsmötet, lämna in en ansökan till EUROTOX i syfte att starta ett nationellt register i enlighet med EUROTOX riktlinjer för European Registered Toxicologists (ERT). 12

13 Några frågor? 13

14 Backups 14

15 EUROTOX riktlinjer (1) Requirements for registration include: Current professional engagement in the practice of toxicology 2 (see section A1). Basic academic degree (see section A2). Theoretical toxicological training in the major areas of toxicology. There are two routes to meet this requirement: Route 1 is by attendance of appropriate courses (see sections A3.1 and B). Route 2 is by practical experience and on the job training (see section A3.2). Practical toxicological training. At least 5 years of relevant toxicological working experience, as shown by e.g. published works, reports or assessments (see sections A4 and C). 15

16 EUROTOX riktlinjer (2) Topics Core Topics A candidate for registration must have undertaken theoretical training in the core topics (B1 B12). Elective Topics In addition, two topics, or one comprehensive topic, of the elective topics listed below (additional topics can be suggested by the applicant), are mandatory. B13. Clinical, Occupational and Forensic B 0. Introduction: History, Tasks, Scope and Toxicology Ethical Principles of Toxicology B14. Drug Safety Assessment: Nonclinical, Clinical, Post Approval Studies, B 1. Animal Science incl. Ethical Rules and 3 R Principles Safety Pharmacology, Expert Report, Drug B 2. Experimental Design, Biometry and Regulation Statistics B15. Safety Assessment of Food, B 3. Cellular Toxicology and Molecular Cosmetics and Other Consumer Products, Toxicology Regulations B 4. Metabolism and Kinetics of Xenobiotics B16. Ecotoxicology B 5. Organ Toxicology and Toxicological B17. Risk Assessment Pathology B18. Neurotoxicology and Behavioural B 6. General Toxicology, Introduction to Risk Toxicology Assessment B19. Nanotoxicology B 7. Environmental Toxicology, Exposure B20. Alternative Testing Methods and Assessment and Biomonitoring SFTs årsmöte april their 2014 Use in the Regulatory Framework 16 B 8. Epidemiology, Toxicogenetics B21. Computational Toxicology B22. Mechanistic Toxicology and Omics in Toxicology

17 EUROTOX riktlinjer (3) Practical Awareness A candidate for registration must have obtained knowledge of major techniques and their merits and limitations (not necessarily hands on experience) in the majority of the topics listed below. In depth knowledge and experience will be expected in at least some of them: C1. Post mortem methods, animal or human pathology and histology. Microscopic recognition of the major pathological processes. C2. Making observations and records of signs of toxicity in animals or humans. Humane dosing, sampling and euthanasia of animals C3. In vivo monitoring, bio-monitoring, biomarker studies on animals or humans. C4. Prevention, diagnosis and treatment of acute or chronic chemical exposure and poisoning. C5. Principles and techniques of cell culture and in vitro toxicity testing. C6. Biochemical and molecular techniques. C7. Standard analytical methods and techniques. C8. Experimental design and/or study design including statistical procedures. C9. Data retrieval, data derivation, databases, data banks, and data acquisition. C10. Determination of pharmacokinetic parameters and compound metabolism. C11. Procedures in risk analysis (risk SFTs assessment, årsmöte april management 2014 and communication), regulatory toxicology, data reliability and relevance. 17

18 EUROTOX riktlinjer (4) Re-registration On a five year basis, Registered Toxicologists will be expected to re affirm their registration credentials and document their continued professional awareness, education and practice. To remain registered, a candidate must be working as a toxicologist, and must submit the following to the registering body: D1. 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. D2. Confirmation of professional activity as a toxicologist in responsible positions by evidence such as list of internal studies (with information on numbers, topics, methods used, branch of customers), list of publications, employment references, delegation into expert committees, teaching and mentoring. D3. Documentation of continued professional awareness and education in Toxicology such as yearly attendance of educational courses and meetings, presentation of lectures or posters, teaching activities, publications, activities in expert committees and similar. These activities will comprise at least five working 18

19 EUROTOX riktlinjer (5) Annex: Rules for the Swedish Registration Committee It is the registration committee that decides upon inclusion, renewal and removal from the register. It is possible to appeal (see below). The registration committee is responsible to the board of SFT. The SFT board appoints members of the committee for a fouryear period at a time. Committee members should represent a wide range of toxicological expertise and employments. The committee comprises five members, of whom at least one must be an SFT board member. During the first three years, one member must come from EUROTOX Registration sub-committee. The SFT board appoints the chairperson of the committee. The committee chooses a secretary and other possible officers from its members. The committee will meet twice a year (meeting dates will be posted in advance on the SFT webpage). The committee maintains the national list of registered toxicologists and gives out certificates as proof of registration. 19

20 EUROTOX riktlinjer (6) Appeals committee Appeals against any decisions of the registration committee can be made to an appeals committee, by first notifying the board of SFT. An appeals committee will convene on a need basis, decided by the SFT board. Members of the appeals committee will include a representative of the SFT board, a representative of the EUROTOX registration sub-committee (not the same as sits on the Swedish registration committee), and at least two additional representatives from other national toxicology societies. 20

21 Svenskt förslag v.s. Finska regler Sweden: Toxicology training: At least MSc with15-26 weeks of toxicology Finland: Min 40 study weeks of toxicology - A professor or senior lecturer (docent) may be included directly in the register - Theoretical training requirement can be met by Route 2: practical awareness and on the job training Expert opinion occasionally required to verify theoretical training Practical awareness specified Must follow the ethical guidelines of the FST Does not mention Route 2 for theoretical tox training practical experience and on the job training Expert opinion not mentioned for theoretical training Practical awareness not mentioned or Quality of practical experience, specified communication skills, authoriship etc specified 21