HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 24 August 2026 EMA/193906/2026 Executive Director

Your Excellency,

Subject: Nomination of a 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 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.

• Toivo Maimets Member 14 January 2027

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 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)

EMA/193906/2026 Page 2/2

• 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.

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/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:

Recommendation on criteria for experience and expertise of CAT members and

alternates

EMA/517622/2015 Page 2/3

 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 3/3

 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.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 24 August 2026 EMA/193906/2026 Executive Director

Your Excellency,

Subject: Nomination of a 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 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.

• Toivo Maimets Member 14 January 2027

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 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)

EMA/193906/2026 Page 2/2

• 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.

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/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:

Recommendation on criteria for experience and expertise of CAT members and

alternates

EMA/517622/2015 Page 2/3

 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 3/3

 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.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 24 August 2026 EMA/193906/2026 Executive Director

Your Excellency,

Subject: Nomination of a 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 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.

• Toivo Maimets Member 14 January 2027

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 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)

EMA/193906/2026 Page 2/2

• 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.

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/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:

Recommendation on criteria for experience and expertise of CAT members and

alternates

EMA/517622/2015 Page 2/3

 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 3/3

 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.

HE the Ambassador Permanent Representation of Estonia Rue Guimard 11–13 B-1040 Bruxelles BELGIUM 24 August 2026 EMA/193906/2026 Executive Director

Your Excellency,

Subject: Nomination of a 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 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.

• Toivo Maimets Member 14 January 2027

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 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)

EMA/193906/2026 Page 2/2

• 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.

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/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:

Recommendation on criteria for experience and expertise of CAT members and

alternates

EMA/517622/2015 Page 2/3

 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 3/3

 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.