Esindajate nimetamine

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union 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

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 8 June 2026 EMA/PDCO/133176/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Paediatric Committee (PDCO) 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 representatives listed below is due to expire. I, therefore, invite you to nominate representatives for a new three-year mandate starting from the date indicated below. In case you are nominating new representatives and a different start date for the mandate is envisaged, please inform me accordingly.

• Jana Lass Member 19 October 2026

• Liisa Saare Alternate 19 October 2026

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

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

Page 2/2

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:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

− NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

An agency of the European Union

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520

Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

22 June 2017 EMA/483011/2015

Inspections, Human Medicines Pharmacovigilance and Committees

Recommendation on criteria for experience and expertise

of PDCO members and alternates

Legislation

Article 4 (1) of Regulation (EC) No 1901/2006 states that the Paediatric Committee shall be composed

of the following members:

(a) five members, with their alternates, of the Committee for Medicinal Products for Human Use,

having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No

726/2004. These five members with their alternates shall be appointed to the Paediatric Committee 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 through the members appointed by the Committee for Medicinal Products

for Human Use.

For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the

Executive Director of the Agency, in order to ensure that the final composition of the Paediatric

Committee, including members and alternates, covers the scientific areas relevant to paediatric

medicinal products, and including at least: pharmaceutical development, paediatric medicine, general

practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance,

ethics and public health.

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

PDCO member and alternate. CHMP members and their alternates are invited to bear this

recommendation in mind when considering putting themselves forward for a CHMP-PDCO joint

membership:

 Academic expertise in the relevant scientific area, such as:

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 2/4

 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 PDCO would be expected to have expertise in one

of the areas of expertise required by the legislation and/or in one of the additional areas of

expertise identified by the Committee:

 Scientific areas relevant to paediatric medicinal products as per legal requirement:

 pharmaceutical development

 paediatric medicine

 general practitioners

 paediatric pharmacy

 paediatric pharmacology

 paediatric research

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 3/4

 pharmacovigilance

 ethics

 public health

 Additional areas of expertise identified by the Committee – therapeutic areas

 cardiovascular diseases

 dermatology

 diagnostic

 endocrinology – metabolism

 gastroenterology

 gynaecology – fertility

 haematology – hemostaseology

 hepatology

 immunology – rheumatology – transplantation

 infectious diseases

 neurology

 oncology

 ophthalmology

 oto-rhino-laryngology

 pain

 pneumology – allergology

 psychiatry

 uro-nephrology

 vaccines

 Additional areas of expertise identified by the Committee – scientific and other areas

 adolescent medicines

 cell therapy – gene therapy – tissue engineering

 clinical pharmacology, modelling and simulation

 extrapolation

 neonatology

 non-clinical development of medicinal products, including expertise in juvenile animal

studies to support neonatal and paediatric studies

 paediatric pharmacovigilance

 pharmacometrics

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 4/4

 quality of medicines, such as expertise on pharmaceutical forms, formulations and

pharmaceutical development

 rare diseases and orphan medicinal products

 statistics in medicine and clinical trials

Whilst a minimum period for 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.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union 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

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 8 June 2026 EMA/PDCO/133176/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Paediatric Committee (PDCO) 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 representatives listed below is due to expire. I, therefore, invite you to nominate representatives for a new three-year mandate starting from the date indicated below. In case you are nominating new representatives and a different start date for the mandate is envisaged, please inform me accordingly.

• Jana Lass Member 19 October 2026

• Liisa Saare Alternate 19 October 2026

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

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

Page 2/2

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:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

− NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union 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

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 8 June 2026 EMA/PDCO/133176/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Paediatric Committee (PDCO) 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 representatives listed below is due to expire. I, therefore, invite you to nominate representatives for a new three-year mandate starting from the date indicated below. In case you are nominating new representatives and a different start date for the mandate is envisaged, please inform me accordingly.

• Jana Lass Member 19 October 2026

• Liisa Saare Alternate 19 October 2026

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

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

Page 2/2

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:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

− NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom

An agency of the European Union

Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520

Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

22 June 2017 EMA/483011/2015

Inspections, Human Medicines Pharmacovigilance and Committees

Recommendation on criteria for experience and expertise

of PDCO members and alternates

Legislation

Article 4 (1) of Regulation (EC) No 1901/2006 states that the Paediatric Committee shall be composed

of the following members:

(a) five members, with their alternates, of the Committee for Medicinal Products for Human Use,

having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No

726/2004. These five members with their alternates shall be appointed to the Paediatric Committee 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 through the members appointed by the Committee for Medicinal Products

for Human Use.

For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the

Executive Director of the Agency, in order to ensure that the final composition of the Paediatric

Committee, including members and alternates, covers the scientific areas relevant to paediatric

medicinal products, and including at least: pharmaceutical development, paediatric medicine, general

practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance,

ethics and public health.

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

PDCO member and alternate. CHMP members and their alternates are invited to bear this

recommendation in mind when considering putting themselves forward for a CHMP-PDCO joint

membership:

 Academic expertise in the relevant scientific area, such as:

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 2/4

 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 PDCO would be expected to have expertise in one

of the areas of expertise required by the legislation and/or in one of the additional areas of

expertise identified by the Committee:

 Scientific areas relevant to paediatric medicinal products as per legal requirement:

 pharmaceutical development

 paediatric medicine

 general practitioners

 paediatric pharmacy

 paediatric pharmacology

 paediatric research

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 3/4

 pharmacovigilance

 ethics

 public health

 Additional areas of expertise identified by the Committee – therapeutic areas

 cardiovascular diseases

 dermatology

 diagnostic

 endocrinology – metabolism

 gastroenterology

 gynaecology – fertility

 haematology – hemostaseology

 hepatology

 immunology – rheumatology – transplantation

 infectious diseases

 neurology

 oncology

 ophthalmology

 oto-rhino-laryngology

 pain

 pneumology – allergology

 psychiatry

 uro-nephrology

 vaccines

 Additional areas of expertise identified by the Committee – scientific and other areas

 adolescent medicines

 cell therapy – gene therapy – tissue engineering

 clinical pharmacology, modelling and simulation

 extrapolation

 neonatology

 non-clinical development of medicinal products, including expertise in juvenile animal

studies to support neonatal and paediatric studies

 paediatric pharmacovigilance

 pharmacometrics

Recommendation on criteria for experience and expertise of PDCO members and

alternates

EMA/483011/2015 Page 4/4

 quality of medicines, such as expertise on pharmaceutical forms, formulations and

pharmaceutical development

 rare diseases and orphan medicinal products

 statistics in medicine and clinical trials

Whilst a minimum period for 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.

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands

An agency of the European Union 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

© European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 8 June 2026 EMA/PDCO/133176/2026 Executive Director

Your Excellency,

Subject: Nomination of representatives in the Paediatric Committee (PDCO) 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 representatives listed below is due to expire. I, therefore, invite you to nominate representatives for a new three-year mandate starting from the date indicated below. In case you are nominating new representatives and a different start date for the mandate is envisaged, please inform me accordingly.

• Jana Lass Member 19 October 2026

• Liisa Saare Alternate 19 October 2026

I would like to emphasize the importance of a timely nomination of a committee member to ensure the continuous representation of your Member State in the Committee. To avoid a vacant committee member position when an alternate position is already filled, you may consider nominating the alternate (temporarily) as member.

Please also inform me if you intend to keep the position temporarily vacant. If no nomination is received, the position will be considered temporarily vacant until a nomination is received.

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

Page 2/2

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:

• Paediatric psychiatry

• Paediatric cardiology

• Non-clinical development of medicinal products, including expertise in juvenile animal studies to support neonatal and paediatric studies

• Biostatistics

• Paediatric neurology

• Paediatric nephrology/urology

• Paediatric radiology/imaging

• Gene therapy

• Medical genetics

− NCA staff member or Academic

An overview of the current composition of the Committee and the expertise of its members is attached for your information.

Please address the nomination to my attention at [email protected] (with copy to [email protected]), indicating full contact details for the nominee and the start date of the mandate, together with any additional information you believe may assist this nomination. In case you already provided me with your nomination, I kindly ask you to disregard this correspondence.

Yours faithfully,

Emer Cooke Executive Director Encs: Annex B Current committee composition and expertise