Esindaja nimetamine

HE Mr Aivo Orav Permanent Representation of Estonia to the European Union Rue Guimard 11-13 B-1040 Brussels BELGIUM 16 November 2022 EMA/8882520/2022 Executive Director Your Excellency, Subject: Nomination of representatives in the Committee for Medicinal Products for Human Use (CHMP) 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. • Edward Laane Alternate 26 March 2023 In making your nominations, please note that the Agency’s Management Board has determined that members of scientific committees should meet conditions concerning their declarations of interests as described in the Policy on the handling of competing interests of scientific committees’ members and experts. This policy can be found on the EMA website. I would like to draw your attention to the attached Annex B, which lists the recommended criteria for experience and expertise of the Committee members and alternates for consideration when nominating a new representative. 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: • Infectious diseases (e.g. COVID-19) • Oncology • Neurology 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, 2022. Reproduction is authorised provided the source is acknowledged. • Ophthalmology • Clinical pharmacokinetics An overview of the current composition of the Committee and the expertise of its members is attached for your information. Please address the nominations to my attention, 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, Emer Cooke Digitally signed by Emer Cooke Date: 2022.11.17 21:06:50 +01'00' Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise EMA/8882520/2022 Page 2/2 Enith Li Saag From: Obon Roger <[email protected]> Sent: reede, 18. november 2022 08:29 To: Esindus EL juures üldaadress Cc: Mairi Kompus; Kärolin Jenas; CHMP DL; Nominations; Edward Laane Subject: Estonia - 2022-11-16 - Nomination invitation for CHMP alternate Attachments: Estonia - 2022-11-16 - Nomination invitation for CHMP alternate.pdf; CHMP List of expertise.xlsx; Annex B_CHMP_EMA recommendation on criteira for competence and expertise of new CHMP members and alternates.pdf 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 the EMA Experts Database, will be required to complete the following documents: • Nomination form for European Experts: PDF version to be completed by the nominee and signed by the Head of the National Competent Authority. The form is available on http://experts.eudra.org/experts/jsp/expertdoc/Nomination_Form_2019.pdf • Public declaration of interests: The blank form is available on http://experts.eudra.org/experts/service/doi/blankform • Electronic CV: During the completion of the eDoI, experts will be requested to submit an electronic CV. This should be completed with as much detail as possible. 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) • Procedural guidance on inclusion of declared interests in the European Medicines Agency’s electronic declaration of interests form (for scientific committees’ members and experts) (link) • Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae (link) 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] | www.ema.europa.eu | For directions, see How to find us 1 Follow us: 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. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately.  Please consider the environment before printing this e-mail Classified as confidential by the European Medicines Agency 2 18 June 2015 EMA/397916/2015 Procedure Management and Committee Support Recommendation on criteria for experience and expertise of CHMP members and alternates The following recommendation on criteria for experience and expertise is made to nominating authorities and committees for consideration when the Agency invites them to nominate a new CHMP member and alternate:  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)  Scientific research (e.g. in epidemiological studies, animal 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 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.   Advisory experience (leading to knowledge of regulatory requirements) in committees’/ scientific bodies’ activities. For example: 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 etc.)  Experience in the review of dossiers, preparation and provision of assessments reports for central and/or national MAAs / experience in peer review of CHMP Assessment Reports/List of Questions  Targeted publications in recognised and peer-reviewed scientific journals and / peer reviewing activities for scientific journals.  Members and alternates nominated to the CHMP would be expected to have expertise in at least one of the following areas – Quality, Non-Clinical, Clinical (general or covering therapeutic areas from the mandatory scope of the centralised procedure), with optional expertise in other therapeutic areas:  Quality  Synthetic chemicals  Biotech and biological  Non-clinical  Pharmacology and toxicology  Clinical (general)  Clinical pharmacology  Clinical pharmacokinetics  Statistics with experience from clinical trials methodology  Pharmacovigilance with expertise in epidemiology  Paediatrics  Clinical (mandatory scope)  Oncology  Diabetes and metabolism  Neurology  AIDS  Auto-immune diseases and other auto-immune dysfunctions  Viral diseases  Advanced therapies (gene, cell, tissue engineered)  Other therapeutic areas identified by the CHMP  Blood products  Cardiovascular diseases  Dermatology Recommendation on criteria for experience and expertise of CHMP members and alternates EMA/397916/2015 Page 2/3   Gastroenterology  Ophthalmology  Psychiatry  Respiratory diseases  Rheumatology and musculoskeletal diseases  Vaccinology 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 CHMP members and alternates EMA/397916/2015 Page 3/3 Saatja: Obon Roger <[email protected]> Saaja: Esindus EL juures üldaadress, Mairi Kompus, Kärolin Jenas, CHMP DL, Nominations, Edward Laane Teema: Estonia - 2022-11-16 - Nomination invitation for CHMP alternate 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 the EMA Experts Database, will be required to complete the following documents: • Nomination form for European Experts: PDF version to be completed by the nominee and signed by the Head of the National Competent Authority. The form is available on http://experts.eudra.org/experts/jsp/expertdoc/Nomination_Form_2019.pdf • Public declaration of interests: The blank form is available on http://experts.eudra.org/experts/service/doi/blankform • Electronic CV: During the completion of the eDoI, experts will be requested to submit an electronic CV. This should be completed with as much detail as possible. 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 electronic declaration of interests form (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>) • Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae (link<https://www.ema.europa.eu/documents/other/guidance-submission-validation-electronic-declaration-interests-electronic-curriculum-vitae_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. If you are not the intended recipient(s) (or authorised by an addressee who received this message), access to this e-mail, or any disclosure or copying of its contents, or any action taken (or not taken) in reliance on it is unauthorised and may be unlawful. If you have received this e-mail in error, please inform the sender immediately. P Please consider the environment before printing this e-mail Classified as confidential by the European Medicines Agency Saatja: Webdesktop <[email protected]> Saadetud: 18.11.2022 13:35 Adressaat: SM Info <[email protected]>; info ravimiamet ee <[email protected]>; Elen Ohov <[email protected]> Koopia: Agne Nettan-Sepp Brüsselis <[email protected]> Teema: Webdesktop: Esindaja nimetamine Euroopa Ravimiameti (EMA) inimtervishoius kasutatavate ravimite komiteesse (CHMP) Tere!Edastan Euroopa Ravimiameti kirja. Reg. number: 14-4/1174Reg. kuupäev: 18.11.2022Sisu: Esindaja nimetamine/uuendamine Euroopa Ravimiameti (EMA) inimtervishoius kasutatavate ravimite komiteesse (CHMP) / Nomination of representatives in the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines AgencyPraeguse liikme pikendamise või uue liikme nimetamise kirja peaks EV alaline esindus EL juures EMAle saatma. Palun saatke info enne nimet tähtaega aadressil [email protected]. Heade soovidegaTiiu [email protected]är, EV alaline esindus EL juures