22 May 2017
EMA/520166/2015
Inspections, Human Medicines Pharmacovigilance and Committees
Recommendation on criteria for experience and expertise
of COMP members
Legislation
Article 4 (3) of Regulation (EC) No 141/2000 states that the Committee for Orphan Medicinal Products
shall consist of one member nominated by each Member State, three members nominated by the
European Commission to represent patients' organisations and three members nominated by the
European Commission on the basis of a recommendation from the European Medicines Agency. The
Regulation does not specify the expertise required for COMP members as is the case for the other
Scientific Committees.
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
COMP member. The Agency will bear them in mind when recommending nominations to the European
Commission:
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)
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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 nominated to the COMP would be expected to have expertise in one of the following
areas of expertise identified by the Committee:
Cardiovascular diseases
Clinical genetics
Dermatology
Endocrinology
Haematology
Hepatology
Immunology
Infectious diseases
Internal medicine
Metabolic diseases
Musculoskeletal disorders
Neurology
Oncology
Ophthalmology
Pulmonology
Psychiatry
Recommendation on criteria for experience and expertise of COMP members
EMA/520166/2015 Page 2/3
Surgery / Transplantation
Urology
Clinical experience with one or more rare diseases in any therapeutic area
Advanced Therapies
Antidotes
Clinical pharmacology
Epidemiology
Health related quality of life
Molecular biology
Paediatrics
Pharmaceutical development
Pre-clinical activities (e.g. pharmacologytoxicology, pharmacokinetics, pharmacodynamics)
Public health
Radiopharmaceuticals
Statistics
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 COMP members
EMA/520166/2015 Page 3/3
Saatja: Obon Roger <
[email protected]>
Saaja: Esindus EL juures üldaadress, Katrin Kiisk, Mairi Kompus, Kärolin Jenas, COMP Secretariat, Nominations, Vallo Tillmann
Teema: Estonia - 2024-01-08 - Nomination invitation for COMP 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
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HE the Ambassador
Permanent Representation of Estonia
Rue Guimard 11–13
B-1040 Bruxelles
BELGIUM
08 January 2024
EMA/8275/2024
Executive Director
Your Excellency,
Subject: Nomination of representatives in the Committee for Orphan Medicinal Products
(COMP) 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.
• Vallo Tillmann Member 17 May 2024
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:
• Statistics (medical statistician, indirect comparisons, epidemiology, prevalence estimations)
• Clinical specialist in:
− Skin disorders (dermatologist)
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
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© European Medicines Agency, 2024. Reproduction is authorised provided the source is acknowledged.
− Infectious diseases
− Ophthalmology
Pulmonology 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: 2024.01.08 14:07:34 +01'00'
Emer Cooke
Executive Director
Encs:
Annex B
Current committee composition and expertise
EMA/8275/2024 Page 2/2
Saatja: "Webdesktop" <
[email protected]>
Saaja: "SM Info", "Elen Ohov",
[email protected]
Teema: Webdesktop: Nomination of representatives in the Committee for Orphan Medicinal Products (COMP)
Kuupäev: 2024-01-08 17:20
Tere!
Edastan Euroopa Ravimiameti kirja.
Palun saata info esinduse e-posti aadressile
[email protected], cc:
[email protected].
Reg. number: 14-4/18
Reg. kuupäev: 08.01.2024
Sisu: Nomination of representatives in the Committee for Orphan Medicinal
Products
(COMP) of the European Medicines Agenc
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Tiiu Noobel
sekretär, EV alaline esindus EL juures
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