Saatja: Obon Roger <
[email protected]>
Saaja: Esindus EL juures üldaadress, Katrin Kiisk, Mairi Kompus, Kärolin Jenas, CHMP DL, Nominations, Alar Irs
Teema: Estonia - 2023-07-10 - Nomination invitation for CHMP 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
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HE the Ambassador
Permanent Representation of Estonia
Rue Guimard 11–13
B-1040 Bruxelles
BELGIUM
10 July 2023
EMA/319503/2023
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.
• Alar Irs Member 13 November 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
• Ophthalmology
• Clinical pharmacokinetics
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.
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,
Digitally signed by Emer
Emer Cooke Cooke
Date: 2023.07.12 19:40:55
+02'00'
Emer Cooke
Executive Director
Encs:
Annex B
Current committee composition and expertise
EMA/319503/2023 Page 2/2
Saatja: Webdesktop <
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Saadetud: 13.07.2023 18:50
Adressaat: <"SM Info">; <"Elen Ohov">; <
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Teema: Webdesktop: Esindaja nimetamine Euroopa Ravimiameti (EMA) inimtervishoius
kasutatavate ravimite komiteesse (CHMP)
Manused: 642.pdf; 642.msg
Tere!
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Reg. number: 14-4/642
Reg. kuupäev: 13.07.2023
Sisu: Esindaja nimetamine 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 Agency (nomination of a representative to the
Agency's Scientific Committees)
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