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Saatja: Obon Roger <[email protected]> Saaja: Esindus EL juures üldaadress, Katrin Kiisk, Mairi Kompus, Kärolin Jenas, CAT Secretariat, Nominations, Toivo Maimets Teema: Estonia -2023-09-04 - Nomination invitation for CAT member Your Excellency, Please find attached a letter signed by the European Medicines Agency's Executive Director requesting the nomination of a representative to the Agency's Scientific Committees. The letter is accompanied by: • Annex B • Committee composition and expertise You are kindly invited to address nominations to the European Medicines Agency’s Executive Director Emer Cooke. Please do not hesitate to contact me should you have any questions regarding this request for nomination. For the information of National Competent Authority in cc of this e-mail, The nominee, if not registered in Experts Management Tool, will be required to register at: (https://experts.ema.europa.eu/) • Registering in Experts Management Tool, Experts will be required to provide: Contact details and areas of expertise, Declaration of Interests, Curriculum Vitae. This should be completed with as much detail as possible. • Instructions on how to register in Experts Management Tool can be found in this (link<https://experts.ema.europa.eu/csp?id=kb_article_view&sysparm_article=KB0010555>) The EMA policy and following guidance documents can be found on the EMA website: • European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts (link<https://www.ema.europa.eu/documents/other/policy-44-european-medicines-agency-policy-handling-competing-interests-scientific-committees_en.pdf>) • Procedural guidance on inclusion of declared interests in the European Medicines Agency’s declaration of interests (for scientific committees’ members and experts) (link<https://www.ema.europa.eu/documents/regulatory-procedural-guideline/procedural-guidance-inclusion-declared-interests-european-medicines-agencys-electronic-declaration_en.pdf>) Nominees will be subject to a pre-screening of any declared competing interest in line with the Agency's policy on handling of competing interests. In case of a negative outcome, the Agency will provide feedback of this screening to the nominating authority for subsequent consideration. Sincerely yours, Roger Obon Experts and Declarations of Interests Management Meeting Secretariat Office Committees and Quality Assurance Department European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands Telephone +31 (0)88 781 6763 [email protected]<mailto:[email protected]> | www.ema.europa.eu<https://www.ema.europa.eu/en> | For directions, see How to find us<https://www.ema.europa.eu/en/about-us/contact/how-find-us> Follow us: [cid:[email protected]] [cid:[email protected]] [cid:[email protected]] [EMA_logo]<http://www.ema.europa.eu/ema/> This message and any attachment contain information which may be confidential or otherwise protected from disclosure. It is intended for the addressee(s) only and should not be relied upon as legal advice unless it is otherwise stated. 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P Please consider the environment before printing this e-mail Classified as confidential by the European Medicines Agency 22 June 2017 EMA/517622/2015 Inspections, Human Medicines Pharmacovigilance and Committees Recommendation on criteria for experience and expertise of CAT members and alternates Legislation Article 21 (1) of Regulation (EC) No 1394/2007 states that the Committee for Advanced Therapies (CAT) shall be composed of the following members: (a) five members or co-opted members of the Committee for Medicinal Products for Human Use from five Member States, with alternates either proposed by their respective Member State or, in the case of co-opted members of the Committee for Medicinal Products for Human Use, identified by the latter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by the Committee for Medicinal Products for Human Use; (b) one member and one alternate appointed by each Member State whose national competent authority is not represented among the members and alternates appointed by the Committee for Medicinal Products for Human Use. Article 21 (2) states that all members of the CAT shall be chosen for their scientific qualification or experience in respect of advanced therapy medicinal products. For the purposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Committee for Advanced Therapies provides appropriate and balanced coverage of the scientific areas relevant to advanced therapies, including medical devices, tissue engineering, gene therapy, cell therapy, biotechnology, surgery, pharmacovigilance, risk management and ethics. At least two members and two alternates of the Committee for Advanced Therapies shall have scientific expertise in medical devices. Recommendation The following recommendation on criteria for experience and expertise is made to nominating authorities in the Member States for consideration when the Agency invites them to nominate a new CAT member and alternate. CHMP members and their alternates are invited to bear this recommendation in mind when considering putting themselves forward for a CHMP-CAT joint membership: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.  Academic expertise in the relevant scientific area, such as:  Internationally recognised academic qualification(s)/accreditation(s) (e.g. degrees, diplomas, post graduate qualifications (e.g. PhD), professional affiliations etc.) in life sciences or physical sciences (medicine, pharmacy, chemistry, biology, …)  Delivering scientific expert views/opinions to National/European/International scientific bodies.  Direct working experience, after obtaining the academic qualification, in the relevant scientific area, in a national competent authority, industry and/or academia/clinical practice (university, hospital, research facility, private practise, etc.). Relevant experience will depend on the core activities of the Committee but could be expected to include experience in one or more of the following areas:  Clinical expertise in one or more therapeutic areas (either as a medical doctor or as a hospital pharmacist)  Clinical co-ordinator/investigator in clinical trials  Member of Data Safety Monitoring Board or Scientific Advisory Board and/or experience of working in or with ethics approval committees  Pre-clinical research and expertise (e.g. in toxicology, pharmacology, animal models)  Clinical research (e.g. clinical trials, epidemiological studies)  Research in the relevant “quality” areas, relating to the research and development of medicinal products (e.g. molecular biology, gene technology)  Formulation, manufacture and control of medicinal products  Pharmacovigilance and risk management  Advisory experience (leading to knowledge of regulatory requirements) in committees’/ scientific bodies’ activities (e.g. member of Working Party or SAG, nominated by EMA or NCA for involvement in EMA activities, experience in providing scientific advice for central and/or national MAs, involvement in WHO, EDQM, FDA activities)  Experience in the review of dossiers, preparation and provision of assessments reports for central and/or national MAAs, experience in peer review of Assessment Reports/List of Questions  Targeted publications in recognised and peer-reviewed scientific journals and/or peer reviewing activities for scientific journals  Members and alternates nominated to the CAT would be expected to have expertise in one of the areas of expertise relevant to advanced therapy medicinal products required by the legislation and/or in one of the additional areas of expertise identified by the Committee:  Areas of expertise relevant to advanced therapy medicinal products as per legal requirement:  cell therapy  gene therapy  tissue engineering  biotechnology  medical devices Recommendation on criteria for experience and expertise of CAT members and alternates EMA/517622/2015 Page 2/3   surgery  pharmacovigilance  risk management  ethics  Additional areas of expertise identified by the Committee  Pre-clinical experience with advanced therapy medicinal products  Clinical experience with advanced therapy medicinal products  Biostatistics  Clinical trial methodology and clinical trials Whilst a minimum period for such post graduate experience is not defined, please note for information, that the length of experience of CHMP and PRAC members and alternates in June 2015 ranged from 2 to 40 years and in 2 out of 3 cases the member had a greater number of years of relevant experience compared to the alternate. Recommendation on criteria for experience and expertise of CAT members and alternates EMA/517622/2015 Page 3/3 Saatja: Webdesktop <[email protected]> Saadetud: 06.09.2023 19:40 Adressaat: <"SM Info">; <"Elen Ohov">; <[email protected]>; <"Liisa Merimaa"> Koopia: <=?utf-8?Q?Agne_Nettan-Sepp_Br=C3=BCsselis?=> Teema: Webdesktop: Eesti esindaja nimetamine Euroopa Ravimiameti uudsete ravimite komiteesse (CAT - Committee for Advanced Therapies) Manused: 848.pdf; 848-lisa_1.pdf; 848-lisa_2.xlsx; 848-edastamismeil.msg Tere! Edastan Euroopa Ravimiameti kirja. Palun saata info esinduse e-posti aadressile [email protected], cc: [email protected]. EV AEEL jures reg. number: 14-4/848 Reg. kuupäev: 06.09.2023 Sisu: Eesti esindaja nimetamine Euroopa Ravimiameti uudsete ravimite komiteesse (CAT - Committee for Advanced Therapies) Nomination of representative in the Committee for Advanced Therapies (CAT) of the European Medicines Agency -- Heade soovidega Tiiu Noobel sekretär, EV alaline esindus EL juures +32 2227 4337 HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 04 September 2023 EMA/399400/2023 Executive Director Your Excellency, Subject: Nomination of representative in the Committee for Advanced Therapies (CAT) of the European Medicines Agency In accordance with Regulation (EC) No 726/2004, members and alternates of the European Medicines Agency’s Management Board and scientific committees are nominated for a three-year mandate by EU member states and EEA-EFTA countries. The three-year mandate of the representative listed below is due to expire. I, therefore, invite you to nominate representative for a new three-year mandate starting from the date indicated below. In case you are nominating new representative and a different start date for the mandate is envisaged, please inform me accordingly. • Toivo Maimets Member 14 January 2024 As agreed with the network of the Heads of Medicines Agencies in order to address the increasing complexity in scientific developments related to the Committee’s activities, the current expertise of the Committee and the expertise required for upcoming procedures are monitored. It would be appreciated if the following specific areas of expertise that were identified as desirable for the current and upcoming work of the Committee, could be taken into consideration when nominating a new representative, subject to the availability of such expertise to the relevant competent authority in your country: • Real world evidence (epidemiologist) • Clinical trial methodology – single-arm clinical trials (biostatistician) • Pharmacovigilance (liaison with PRAC) • Medical devices • Clinical experience with advanced therapy medicinal products • Non-clinical experience with advanced therapy medicinal products NCA staff member preferred as member and academic as alternate An overview of the current composition of the Committee and the expertise of its members is attached for your information. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged. Please address the nominations to my attention at PO Box 71010, 1008 BA Amsterdam, The Netherlands, indicating full contact details for the nominees and the start date of the mandate, together with any additional information you believe may assist these nominations. In case you have already provided me with your nominations, I kindly ask you to disregard this correspondence. Yours faithfully, Digitally signed by Emer Cooke Emer Cooke Date: 2023.09.06 11:42:58 +02'00' Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise EMA/399400/2023 Page 2/2