Rose-Marie Tunier Dominique Martin Evelyne Duplessis ...ansm.sante.fr/var/ansm_site/storage/original/application/d2f8cb590... · Public Policies and Innovation Processes Head of Department

Communication and Information Division

Rose-Marie Tunier

Accounting OfficerSandrine Gaborel

Budget ControllerDominique Arbelet

Human Resources Division

Marie Balland

Information Technology Division

Raphaël Martin

Finance and Administration Division

David Trivié

Division for Data Flowsand Repositories

Wenceslas Bubenicek

Deputy Director Generalfor Operations

Christelle Ratignier-Carbonneil

Ethics of Expertise DepartmentElisabeth Hérail - Ethics Officer

Emergency Situations, Scientific Affairs and

European Strategy DivisionJean-Claude Ghislain

Deputy Director Generalfor Resources

Eric Délas

Director General

Dominique Martin

Product Divisions

Surveillance DivisionPatrick Maison

Authorisation and

Innovation Policies Division

Elodie Chapel

Inspection Division

Bernard Celli

Div

isio

n for

Generic,

Hom

eopath

ic,

Herb

al M

edic

ines a

nd

Pre

para

tions

Val

érie

Salo

mo

n

Laboratory Controls DivisionFrançoise Duperray

Div

isio

n f

or

Dia

gnosis

Medic

al

Devic

es a

nd M

edic

al D

evic

es

Equip

ments

Nic

ola

s Th

éven

et

Legal and Regulatory

Affairs Division

Carole le Saulnier

Div

isio

n for

Thera

peutic M

edic

al

Devic

es a

nd C

osm

etics

Bir

gitt

eH

euls

Operating Divisions

December 2017

Steeringand Internal Control Unit

Evelyne Duplessis

Project Manager

N.

Div

isio

n o

f M

edic

ines u

sed in

Oncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

, T

issues,

and

Labile

Blo

od P

roducts

Lo

tfi

Bo

ud

ali

Div

isio

n o

f M

edic

ines u

sed in

Card

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrinolo

gy,

Gyn

aecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, and A

llerg

olo

gy

Jean

-Mic

hel

Rac

e

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psyc

hia

try,

Anaesth

esio

logy,

Pain

Contr

ol,

Ophth

alm

olo

gy,

Narc

otics,

Psyc

hotr

opic

s,

and A

ddic

tions

Ph

ilip

pe

VEL

LA

Div

isio

n o

f V

accin

es,

Anti-I

nfe

ctive

Medic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py

and

Rare

Meta

bolic

Dis

eases

Caro

lin

e S

em

aille


Rose-Marie Tunier



Ethics of Expertise Department

Elisabeth Hérail – Ethics Officer

Emergency Situations, Scientific Affairs and

European Strategy DivisionJean-Claude Ghislain


Eric Délas

Director General

Dominique Martin

General Office

Steeringand Internal Control Unit

Evelyne Duplessis

December 2017

Project Manager

N.



Product Division

Surveillance DivisionPatrick Maison

Authorisation and

Innovation Policies Division

Elodie Chapel

Inspection Division

Bernard Celli

Div

isio

n o

f M

edic

ines

use

din

O

nco

logy

, Hae

mao

logy

, Tr

ansp

lan

tati

on

, N

eph

rolo

gy, C

ell

Ther

apy

Pro

du

cts,

Tis

sues

, an

d L

abile

B

loo

d P

rod

uct

s

Lotf

i Bo

ud

ali

Div

isio

n o

n M

edic

ines

use

din

C

ard

iolo

gy, R

heu

mat

olo

gy,

Sto

mat

olo

gy, E

nd

ocr

ino

logy

, G

ynae

colo

gy, U

rolo

gy, P

ulm

on

olo

gy,

ENT,

an

d A

llerg

olo

gy

Jean

-Mic

he

l Rac

e

Div

isio

n o

f M

edic

ines

use

dfo

r N

euro

logy

, Psy

chia

try,

A

nae

sth

esio

logy

, P

ain

Co

ntr

ol,

Op

hta

lmo

logy

, Nar

coti

cs,

Psy

cho

tro

pic

s, a

nd

Ad

dic

tio

ns

Ph

ilip

pe

Ve

lla

Div

isio

n o

f V

acci

nes

, An

ti-I

nfe

ctiv

eM

edic

ines

, H

epat

oga

stro

ente

rolo

gy,

Der

mat

olo

gy, G

ene

Ther

apy,

an

d

Rar

e M

etab

olic

Dis

ease

sC

aro

line

Se

mai

lle

Laboratory Controls DivisionFrançoise Duperray

Dir

ecti

on

des

dis

po

siti

fs m

édic

aux

thér

apeu

tiq

ues

et

des

co

smét

iqu

esB

rigi

tte

He

uls

Legal and Regulatory Affairs Division

Carole le Saulnier

Dir

ecti

on

des

dis

po

siti

fs m

édic

aux

de

dia

gno

stic

s et

des

pla

teau

x te

chn

iqu

es

Nic

ola

s Th

éve

net

Op

era

tin

g D

ivis

ion

s

Dir

ecti

on

des

méd

icam

ents

gé

nér

iqu

es, h

om

éop

ath

iqu

es,

à b

ase

de

pla

nte

s et

des

pré

par

atio

ns

Val

éri

e S

alo

mo

n

General Operations

December 2017


Eric Délas


Marie Balland


Raphaël Martin


David Trivié


Wenceslas Bubenicek

General Resources

December 2017

Deputy Director Nicolas Thévenet

Epidemiology of Health ProductsHead of DepartmentRosemary Dray Spira

DirectorJean-Claude Ghislain

European Medicines Strategy Steering Centre

Head of DepartmentN.

Support Centre for Emergency Situations,Health Alerts and Risk Management

Head of DepartmentNicolas Thévenet

Emergency Situations, Scientific Affairsand European Strategy Division

Director GeneralDominique Martin

December 2017

Deputy Director Pierre Démolis

Scientific AdviserMahmoud Zureik

Scientific Affairs & Boards & Committees’ Coordination

Head of DepartmentMarie-Lise Migueres

Deputy DirectorTiphaine Canarelli

Digital, Media and MonitoringHead of Department

N.

Institutional Communication and Public InformationHead of Department

Isabelle Vernhes

Director GeneralDominique Martin

DirectorRose-Marie Tunier


December 2017

Internal CommunicationsPatricia Logghe-Jewkes

Deputy DirectorN.

Director David Trivié

Procurement and ContractsHead of DepartmentFabrice de Fuentes

Maintenance Services Head of Department

Didier Leuridan

Budget and Expense ManagementHead of Department

Stéphane Trioux

Defence and SecurityStéphane Degryse

Logistics and Internal Services Team Manager

Bérangère Barrau

Real Estate Works and Strategy

Team Manager Ahmed Khezzane



Eric Délas

December 2017

Deputy DirectorDavid Morelle

Director Wenceslas Bubenicek



Eric Délas

Data Flows and Master Data Management

Head of Department Anne-Laure Camara

Records Management, Archiving,

and Process ControlHead of Department

Anne Decool

Repository ManagementHead of Department

Laurence Lefebvre-Raisin

December 2017

Dossier ManagementHead of Department

Mouna Houdon

Scientific AdvisorAntoine Sawaya

Project Management SteeringHead of Department Christophe Baheux


Director Marie Balland

Personnel and Expert Management

Head of DepartmentArnaud Helfre

Human Resources SteeringHead of Department

Anne Guillouzo

Training and DevelopmentHead of DepartmentValérie Kermagoret

Deputy DirectorAnne Guillouzo


Eric Délas

Workplace Environment and Social Dialogue

Head of DepartmentPaméla Guerreiro

December 2017


Eric Délas

Deputy Director - CISOJean-Philippe Labille

IT Operations and Service DeliveryHead of Department Jean-Louis Tsolissos

IT Studies and ProjectsHead of Department

Silvia Coman

Director Raphaël Martin

IT Architecture and Cross-functional Projects

Head of DepartmentNicolas Delemer


December 2017

Assistant to the Accounting Officer Authorised representative

Béatrice Escande

Supply and Accountancy DepartmentSuzy Faro

Department in charge of Compensationand AssignmentsLaetitia Dumont

Accounting Officer

Sandrine Gaborel

Accounting

December 2017

Financial CoordinatorJoëlle Bensalah

Safety ProcessesHead of Department

Claire Férard

Process and Network ManagementHead of DepartmentAnne-Charlotte Sailly

Reporting ManagementHead of Department

Mehdi Benkebil

Quality Defect and Supply ShortagesHead of Department

Dominique Debourges

Deputy DirectorCéline Mounier

Div

isio

n for

Th

era

peutic M

edic

al D

evic

es a

nd C

osm

etics

Div

isio

n for

Generic,

Hom

eopath

ic a

nd H

erb

al M

edic

ines a

nd P

repara

tio

ns

Div

isio

n for

Dia

gnosis

Medic

al D

evic

es a

nd M

edic

al D

evic

es E

quip

ments

Op

era

tin

g D

ivis

ion

DirectorPatrick Maison

Product Divisions



Surveillance Division

Deputy DirectorN.

December 2017 Div

isio

n o

f M

edic

ines u

sed in O

ncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

,

Tis

sues,

and L

abile

Blo

od P

roducts

Div

isio

n o

f M

edic

ines u

sed in C

ard

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrinolo

gy,

Gyn

aecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, and A

llerg

olo

gy

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psyc

hia

try,

Anaesth

esio

logy,

Pain

Contr

ol, O

phth

alm

olo

gy,

Narc

otics,

Psyc

hotr

opic

s,

and A

ddic

tions

Div

isio

n o

f V

accin

es,

Anti-I

nfe

ctive M

edic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py

and R

are

M

eta

bolic

Dis

eases

EvaluationHead of DepartmentBéatrice Porokhov

Legal AffairsHead of Department

José Luis Da Silva

Regulatory AffairsHead of Department

Julie Cavalier

Import, Export and Qualification of Health Products

Acting Head of DepartmentFranck Augouvernaire

Op

era

tin

g D

ivis

ion

Product Divisions

Div

isio

n o

f M

edic

ines u

sed in O

ncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

,

Tis

sues,

and L

abile

Blo

od P

roducts

Div

isio

n o

f M

edic

ines u

sed in C

ard

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrinolo

gy,

Gyn

aecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, and A

llerg

olo

gy

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psyc

hia

try,

Anaesth

esio

logy,

Pain

Contr

ol, O

phth

alm

olo

gy,

Narc

otics,

Psyc

hotr

opic

s,

and A

ddic

tions

Div

isio

n o

f V

accin

es,

Anti-I

nfe

ctive M

edic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py

and R

are

M

eta

bolic

Dis

eases

Div

isio

n for

Th

era

peutic M

edic

al D

evic

es a

nd C

osm

etics

Div

isio

n for

Generic,

Hom

eopath

ic, H

erb

al M

edic

ines a

nd P

repara

tio

ns

Div

isio

n for

Dia

gnostic M

edic

al D

evic

es a

nd T

echnic

al P

latf

orm

s



DirectorCarole le Saulnier


December 2017



Steering and Security of Operations, Processes and Pharmacopoeia

Acting Head of DepartmentTo Quynh Gandolphe

Public Policies and Innovation Processes

Head of DepartmentDominique Masset

Centralised EvaluationHead of Department

N.

Deputy DirectorMarc Martin

Op

era

tin

g D

ivis

ion

Product Divisions

Div

isio

n for

Th

era

peutic M

edic

al D

evic

es a

nd C

osm

etics

Div

isio

n for

Generic,

Hom

eopath

ic, H

erb

al M

edic

ines a

nd P

repara

tio

ns

Div

isio

n for

Dia

gnosis

Medic

al D

evic

es a

nd M

edic

al D

evic

es E

quip

ments

DirectorElodie Chapel

Authorisation and Innovation Policies Division

December 2017 Div

isio

n o

f M

edic

ines u

sed in O

ncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

,

Tis

sues,

and L

abile

Blo

od P

roducts

Div

isio

n o

f M

edic

ines u

sed in C

ard

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrinolo

gy,

Gyn

aecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, and A

llerg

olo

gy

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psyc

hia

try,

Anaesth

esio

logy,

Pain

Contr

ol, O

phth

alm

olo

gy,

Narc

otics,

Psyc

hotr

opic

s,

and A

ddic

tions

Div

isio

n o

f V

accin

es,

Anti-I

nfe

ctive M

edic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py

and R

are

M

eta

bolic

Dis

eases

Inspection Methodology and ResourcesHead of Department

Carole Peter-Decarsin

Market Surveillance Inspection

Head of DepartmentJulien Dupont

Trials and Vigilance InspectionHead of Department

Corinne Kiger

Starting Materials Inspection Head of Department

N.

Deputy DirectorGuillaume Renaud

Deputy DirectorDominique Labbé

Biological Products Inspection 2Head of Department

Cyril Stern

Pharmaceutical Product Inspection and Counterfeiting Fight 1

Head of DepartmentMélanie Cachet

Pharmaceutical Product Inspection and Counterfeiting Fight 2

Head of DepartmentVirginie Waysbaum

DirectorBernard Celli

Op

era

tin

g D

ivis

ion

Div

isio

n forT

hera

peutic M

edic

al D

evic

es a

nd C

osm

etics

Div

isio

n for

Generic,

Hom

eopath

ic, H

erb

al M

edic

ines a

nd P

repara

tio

ns

Div

isio

n for

Dia

gnosis

Medic

al D

evic

es a

nd M

edic

al D

evic

es E

quip

ments



Special adviserXavier Cornil

Product Divisions

Inspection Division

Biological Products Inspection 1Head of Department

Romain Rotival

December 2017 Div

isio

n o

f M

edic

ines u

sed in O

ncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

, T

issues,

and

Labile

Blo

od P

roducts

Div

isio

n o

f M

edic

ines u

sed in

Card

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrin

olo

gy,

Gynaecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, and A

llerg

olo

gy

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psychia

try, A

naesth

esio

logy,

Pain

Contr

ol, O

phth

alm

olo

gy,

Narc

otics, P

sychotr

opic

s, and A

ddic

tio

ns

Div

isio

n o

f V

accin

es, A

nti-I

nfe

ctive M

edic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py a

nd

Rare

Meta

bolic

Dis

eases

Deputy DirectorJacques Morénas

Op

era

tin

g D

ivis

ion

Product Divisions

Div

isio

n for

Th

era

peutic M

edic

al D

evic

es a

nd C

osm

etics

Div

isio

n for

Generic,

Hom

eopath

ic, H

erb

al M

edic

ines a

nd P

repara

tio

ns

Div

isio

n for

Dia

gnosis

Medic

al D

evic

es a

nd M

edic

al D

evic

es E

quip

ments

Laboratory Controls Division



----------------------------------Deputy Directors

----------------------------------

Quality Management Quality Coordinator

Isabelle Puff

In charge of chemical medicines and other

health product market surveillance and standardisation

Frédérique Barbosa

DirectorFrançoise Duperray

In charge of support functions, batch releases

and the market surveillance of biological

products

Séverine Cauchard

Administrative Logistics Departments

Scientific and Administrative Logistics - Saint-DenisHead of Department: Francis Poisson

Scientific and Administrative Logistics - MontpellierHead of Department: Teddy Aboulafia

Scientific and Administrative Logistics - LyonHead of Department: Caroline Moreau

Biological Control of Immunological Medicines and Biological Safety

Head of Department: Stéphane Maisonneuve

Bath Release and Market Surveillance for Biological ProductsHead of Department: François Cano

Biological and Microbiological Control of Health ProductsHead of Department: Didier Sauvaire

Control of Biological ProductsHead of Department: Olivier Garinot

Market Surveillance for Chemical Medicines and other Health Products

Head of Department: Denis Chauvey

Physico-chemical Control of Chemical Medicines and other health Products

Head of Department: Charlotte Brenier

Thematic Departments

Technical Departments

December 2017

Div

isio

n o

f M

edic

ines u

sed in O

ncolo

gy,

Haem

ato

logy,

Tra

nspla

nta

tion,

Nephro

logy,

Cell

Thera

py

Pro

ducts

, T

issues,

and L

abile

Blo

od

Pro

ducts

Div

isio

n o

f M

edic

ines u

sed in C

ard

iolo

gy,

Rheum

ato

logy,

Sto

mato

logy,

Endocrinolo

gy,

Gyn

aecolo

gy,

Uro

logy,

Pulm

onolo

gy,

EN

T, a

nd

Alle

rgolo

gy

Div

isio

n o

f M

edic

ines u

sed f

or

Neuro

logy,

Psyc

hia

try,

Anaesth

esio

logy,

Pain

Contr

ol, O

phth

alm

olo

gy,

Narc

otics,

Psyc

hotr

opic

s,

and

Addic

tions

Div

isio

n o

f V

accin

es,

Anti-I

nfe

ctive M

edic

ines,

Hepato

gastr

oente

rolo

gy,

Derm

ato

logy,

Gene T

hera

py

and R

are

Meta

bolic

Dis

eases

Deputy DirectorGaëlle Guyader

Haematology,

Immunotransplantation,

Nephrology

Product Manager

Peggy Chocarne

Haemovigilance, Labile Blood Products,

Cell Therapy and

Radiopharmaceutical Products

Product Manager

Isabelle Sainte-Marie


Evaluation Division


Inspection Division


DirectorLotfi Boudali



Division of Medicines used in Oncology, Haematology, Transplantation, Nephrology,

Cell Therapy Products, Tissues, and Labile Blood Products

Pro

du

ct D

ivis

ion

Op

era

tin

g

Div

isio

ns

Oncology

Product Manager

Vincent Gazin

Deputy DirectorCéline Druet

Cardiovascular Diseases, Thrombosis, Metabolism, Rheumatology,

Stomatology

Product Manager

Gwennaelle Even

Endocrinology, Gynaecology, Urology, Pulmonology, ENT, and Allergology

Product Manager

Isabelle Yoldjian


Evaluation Division


Inspection Division


DirectorJean-Michel Race

Pro

du

ct D

ivis

ionDeputy Director General

for Operations Christelle Ratignier-Carbonneil

Division of Medicines used in Cardiology, Rheumatology, Stomatology, Endocrinology,

Gynaecology, Urology, Pulmonology, ENT, and Allergology

Op

era

tin

g

Div

isio

ns

Neurology, Psychiatry,

Anaesthesiology and Medicines

used for Alcohol Addiction

Product Manager

Catherine Deguines

Pain Control, Nonsteroidal Anti-Inflammatories, Ophthalmology and

Medicines used for Tobacco Addiction

Product Manager

Sylvain Gueho

Narcotics, Psychotropics

and Medicines used for Addiction

to Narcotics

Product Manager

Aldine Fabreguettes

Deputy DirectorNathalie Richard


Evaluation Division


Inspection Division


DirectorPhilippe Vella



Division of Medicines used for Neurology, Psychiatry, Anaesthesiology, Pain Control,

Ophthalmology, Narcotics, Psychotropics, and Addictions

Pro

du

ct D

ivis

ion

Op

era

tin

g

Div

isio

ns

Deputy DirectorAlban Dhanani

Virology and Gene Therapy

Product Manager

Nathalie Morgensztejn

Dermatology, Hepatogastroenterology and Rare Metabolic Diseases

Product Manager

Nathalie Dumarcet


Evaluation Division

Monitoring Division

Inspection Division

Laboratories Control Division

DirectorCaroline Semaille



Division of Vaccines, Anti-Infective Medicines, Hepatogastroenterology, Dermatology,

Gene Therapy and Rare Metabolic Diseases

Pro

du

ct D

ivis

ion

Op

era

tin

g

Div

isio

ns

Vaccines, Antibiotics, Antifungals and Antiparasitics

Product Manager

Isabelle Parent

Deputy DirectorAlain Richard

Safety and Management of Generic Medicine processesHead of Department

Gaëlle Louin

Homeopathic, Herbal Medicines and Preparations

Head of DepartmentAn Lê


Evaluation Division


Inspection Division


Valérie Salomon



Division for Generic, Homeopathic, Herbal Medicines and Preparations

Pro

du

ct D

ivis

ion

Op

era

tin

g

Div

isio

ns

Scientific Co-ordination of the Evaluation of Generic Medicines and

ASMFHead of Department

Pascale Le Bleis

Cardiovascular Medical DevicesHead of Department

Nathalie Marliac

Orthopaedic Medical Devices and other Surgeries

Head of DepartmentVirginie Di Betta

Consumer Medical Devices and Cosmetics

Head of DepartmentHélène Duvignac

Deputy DirectorThierry Thomas


Evaluation Division


Inspection Division


DirectorBrigitte Heuls

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Division for Therapeutic Medical Devices and Cosmetics

Deputy DirectorThierry Sirdey

Medical Devices for In Vitro Diagnosis Head of DepartmentMarianne Deschenes

Medical Devices for Operating Theatre and Intensive Care

Head of DepartmentPascal Di Donato

DirectorNicolas Thévenet


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Division for Diagnosis Medical Devices and Medical Device Equipments

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Medical Devices for X-rays, Injection, Patient-Assistance and Softwares

Head of DepartmentHélène Bruyère

Documents

Rose-Marie Tunier Dominique Martin Evelyne Duplessis ...ansm.sante.fr/var/ansm_site/storage/original/application/d2f8cb590... · Public Policies and Innovation Processes Head of Department