International Congress 1263

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Biarritz - France - October 15th, 16th & 17th, 2013

SIMULTANEOUS TRANSLATION FRENCH/ENGLISH

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16 Lectures 11 Workshops
Exhibition Round table

A3P
Services
22, Rue Aristide Briand

45220 Chteau-Renard - France


Tl. +33 2 38 071 071
Fax +33 2 38 071 072
E-mail : info@a3pservices.com

www.a3p.org

Editorial
Sterility Assurance, a permanent concern!
Endless topic is the STERILITY ASSURANCE, subject that will gather the 2013
participants to the A3P 26th congress in Biarritz, along with the SINGLE USE
SYSTEMS and COMBINATION PRODUCTS, the whole being today more and more
frequently associated for the administration of treatments sometime complex. The
presentations will put these topics into perspective, with their practical aspects
which are daily questioning all contributors of the production chain. They are always
looking for improvements and innovations made possible by the evolution and
development of new technologies; they force us to reopen the basics of current
practices, what is really understood, but most and foremost what remains essential, in order to envisage
the evolutions around these practices, all to the service to the patient. Experts will share their experience
and potential perspectives.
The round table will discuss these questions in a structured manner, to review current thinking and
evaluate the conditions to fulll for the promotion of these evolutions, never forgetting that Sterility has
only for good Company the Assurance that supports it!

Patrick TURLIER - GSK


Illustration Franois MOREL

Entire plant is for single use!


...except the staff.
Who knows...

Biarritz 2013

Lectures

Tuesday October 15th


All the lectures are located in the Bellevue Congress Hall.
8h00

Welcome to the participants at the Bellevue Space

8h45

Introduction by the President of A3P Association


Grard Ecotire

8h50

Opening lecture
Patrick Turlier - GSK

9h00

When sterility assurance fails


Jean-Denis Mallet - NNE Pharmaplan

9h30

Environmental Monitoring & Process Understanding


Ian Symonds - GSK

10h00 From ionizing radiation of a MD to the sterility assurance of a combination product


Bruno Tissier - IPSEN
10h30 Break - Visit of the Exhibition
11h30 Rapid Microbial Methods (RMM) The Microbiology of the 21st century?
Benoit Ramond - Sano
12h00 VHP decontamination without Rogue Bis
Sverine Itier - Icare
12h30 The simulation of the aseptic process as a tool to improve the manufacturing process of the yellow
fever vaccine bulk
Antoine Diatta - Institut Pasteur de Dakar
13h00 Lunch
15h00 Risk analysis in aseptic process: how to quantify the aseptic risk on a conventional lling line or an
isolator ?
Emmanuelle Bracq - Lilly
15h30 Sterile single dose leak test by vacuum vaporisation
Jean Jaillot - Excelvision
16h00 Introduction of Technological Innovations for Improvement of Sterility Assurance Level of Vaccine
Manufacturing Processes
Antoine Akar - GSK Vaccine
16h30 Break - Visit of the Exhibition
17h30 cGMP requirements for Combination products: an overview of 21 CFR 4
Philippe Joly - Easy Gmp
18h00 Combination Products: Trends and Emerging Technologies
Andrew Koubatis - Altran
18h30 Exhibitors cocktail

More informations and current events


about the Congress on

www.a3p.org

Workshops
Wednesday October 16th
All the workshops are located in the Bellevue Hall.
8h30 Welcome to the particpants at the Bellevue Hall - Biarritz (France)
9h00 1st part of workshops (Choose your workshop from the following list and report your choice on the registration from page 11)
10h30 Break - Visit of the exhibition
12h30 Lunch
14h00 2nd part of workshops
16h00 Break - Visit of the exhibition
17h30 End of the workshops
20h00 Exclusive and unique Gala Dinner

List of workshops to choose from: The workshops are provided without simultaneous translation.
WORKSHOP N1 (in french)

Implementation of a system of disinfection on injectable factory in biotechnology


A3P Representative: Isabelle Pautrel
Moderators: Ludovic Dreux - Genethon et Fabien Guerrin - Areco
The purpose of the workshop will be to conduct a project to install a system for decontaminating surfaces by air on a unit of production GMP on injectable product
in biotech.
The implementation of this project will be to confront with the different problems of each phase, necessary for a successful installation
- From implementations plans of a production unit, define the specifications of air handling unit with its associated bio-decontamination device
- Define the monitoring needs of the system
- Define checkpoints and acceptance tests associated with setting up the system
- Define the qualification tests to establish : FAT, SAT, IQ, OQ
- Define preventive maintenance associated to be provided on the unit of injectable production, such as premises and equipment involved
At the end of the workshop, it will be presented feedback on one installation of a disinfecting system in a production of injectable in biotech.

WORKSHOP N2 (in french)

Aseptic process How to answer to remarks following inspections


(e.g. FDA, ANSM, ANSES)
A3P Representative: Jacques Navellou
Moderators: Olivier Chancel - Merial et Benoit Ramond -Sanofi
This workshop is intended for everyone, novices or experimented, and is considered as a training, a way to discover, to enhance its aseptic culture or simply to
test its own arguments It will let participants design a methodology on how to answer to remarks whatever they are and then answer altogether remarks following
an inspection on the aseptic field.
The workshop begins with a short presentation of the recent trends in terms of remarks issued by FDA/ANSM/ANSES inspections.
The workshop alternates sessions in subgroups as well as common sessions in a rather fast way so as to favor the diversity:
10 minutes of reflection in subgroups: Sterile Quality control subgroup by Benoit Ramond and aseptic Proceeded subgroup by Olivier Chancel
2x5 minutes of collective feedback to all the participants. Remarks studied during the workshop are 3 orders: - Usual remarks: "It is a school case and my site
should be ready to face it", - Current remarks: "My site might get this remark the next time ", - Badly formulated remark: "Great, I am going to be able to develop
my critical faculty".
The workshop ends by a short presentation on a possible way to answer to FDA/ANSM/ANSES.

HOP

ORKS
PLETE W

COM

Biarritz 2013

Workshops

Wednesday October 16th


WORKSHOP N3

Trending data of environmental monitoring in a bio-decontaminated cleanroom


A3P Representative: Didier Meyer
Moderators: James Drinkwater - PHSS et Jules Boulicot- Bioquell
Theory talks will be provided on cleanroom environmental monitoring, including the new ISO 14644 for Cleanroom Classification, and cleanroom biocontamination
risk management and guidance, including the new PHSS Monograph titled Controlled Environment Biocontamination Control. Workshops will include general
cleanroom classification and environmental monitoring programs and root cause analysis and CAPA on bio-contamination events.

WORKSHOP N4 (in french)

From aseptic manufacturing to gamma sterilisation of a combination product


A3P Representative: Vincent Griffoul
Moderators: Bruno Tissier - Ipsen et Gilles Daneyrolle - Ionisos
This case study workshop will work on the example of the re-ingeneering of an existing aseptic processed drug product, to a new combo presentation sterilized by
gamma irradiation. In a second time, the option of parametric release advantages and practicability would be discussed.
Taken into account the current EU applicable reference standards, each of the three sub group will work respectively on: 1) the medical device 2) the drug Product
and 3) design of the specific validation plan.
Pragmatical methodology, main critical parameters of device and process, and finally parametric release will be considered and evaluated.

WORKSHOP N5 (in french)

Analysis of criticality function/constituent of a system of cleaning in place (CIP)


A3P Representative: Sophie Amadio
Moderators: Robin Bigot - Cophaclean et Sandrine Duclos - Novartis Sant Animale
Presentation of a method of criticality analysis function/component adapted to a system of cleaning in place (CIP) in pharmaceutical industry, allowing: to define the
tests of qualification to be made, to maintain the conditions of this qualified state, to simplify the process of change control.
Trough this methodology, this worshop will allow the participants to improve their knowledge on the functioning of a system of cleaning in place.
The progress of the day: presentation of the methodology, overview on a real case scenario: definition of the functions, the components and tests of associates
qualification.

WORKSHOP N6 (in french)

Bacterial and viral biofilms prevent from production and preservation of germ free
water. These bacterial and viral communities are genuine biological fortress,
bactericidal and virucidalproof. In order to obtain pharmaceutical pure waters,
protected against exogenous contaminations, specific water treatment production
systems and devices are introduced with additional instructions.
A3P Representative: Arnaud Carlotti
Moderators: Henry Lerat - Burkhalter AG et Frdrique Le Bouquin - Veolia Water France
Biofilms
1-a) well study their development (from birth to lysis). First particles adhesion growth glycocalyx forming ripeness and lysis. Well study also bacterial ADN
as glycocalyx reinforcement agent.
1-b) Viral biofilm: specific analysis
2) Work shop. The participants in work shop conceive a biofilm free plant and biofilm free purified water loop from their knowledge.
3) Remedy. Well study participants solutions. Well introduce our own solutions pertaining to biofilm free purified water plant biofilm free purified water (liquid
storage plant and loop).
4) Well introduce specific process to preserve production shop devices from biofilms contamination.

More informations and current events


about the Congress on

www.a3p.org

Workshops
Wednesday October 16th
WORKSHOP N7 (in french)

Continued Process Verification: how to improve your process control by a


comprehensive and integrated approach?
A3P Representative: Jean-Louis Jouve
Moderators: Claire Choplin - Aktehom et Anne Rigoulot - Sanofi Pasteur
Regulatory authorities evolutions in terms of process validation integrate the concepts of continual improvement and knowledge management described in the
different ICH guidelines. Even if Annex 15 still remains the main reference for process validation, it is however no more in line with these concepts. Continued
process verification integrates these regulatory changes described in the Guidance for Industry (FDA), but also in the European reference (EMA). On the basis of these
new regulations, authorities are moving towards an integrated approach of validation, based on a Quality by Design approach. This implies the identification of
critical parameters and quality attributes to perform product and process characterization. In the case of existing products, the aim is not to question the initial
validation but to continuously monitor, using relevant indicators, the product quality and process performance in a continual improvement objective. Regarding this
regulatory evolution, manufacturers must implement the adapted mechanisms, tools and organization to monitor and evaluate their existing or new processes.
Ultimately, the purpose is to prove the process robustness by identifying sources of variability, their impact on the product quality, and to implement regularly and
proactively, appropriate improvement or corrective actions. To introduce this workshop, the regulatory context and the main principles of continued process verification
will be presented. Gains and difficulties in its implementation will be also shared. Then a pragmatic and operational implementation of continued process verification
based on an existing pharmaceutical manufacturing process will be worked on in small groups. Finally, each group will propose an organization and a procedure to
implement this new approach. Each proposal will be commented and challenged by all participants, providing a comprehensive and practical overview of the
maintenance of the state of control process (validated state).

WORKSHOP N8 (in french)

Daily Risk Management: From identification to follow up and review on EHS / Quality
& Business risks in vaccines production
A3P Representative: Roland Guinet
Moderators: Antoine Maximillien et Francis Leclercq - GSK Saint Amand
The workshop on Daily Risk Management will address several aspects:
Identification of Business / EHS & Quality risks from an example about vaccines processes.
Assessment: the formalization and the way to proritize will be treated, with risks identified from the example and the method to calculate their score
Remedial actions: root cause analysis tools will be used in order to identify the appropriate actions to be implemented with for example, root cause analysis
methodology and the tool 5 why.
Follow up and review: examples of operational management tools such as Risk register and Key Performance Indicators (KPIs) will be developed.

WORKSHOP N9 (in french)

Quality by Design for the management of pharmaceutical water using loops


A3P Representative: Herv Tassery
Moderators: Samah Ringa - BWT Permo et Robert Neri - Sanofi
The objective of the workshop is to apply the approach of "Quality by Design" (ICH Q8) to an installation of water production for pharmaceutical use. This will be
deployed for optimal mastery of the installation. Particular attention will be paid to the following points: Qualifications: from design to performance measurement,
The conduct of everyday facilities (monitoring, log book, preventive maintenance... etc), The management of microbial contamination (flora card, microbiological
monitoring, treatment results "Out Of Specifications" biofilm and disinfection).
The purpose of this workshop is to realize that the implementation and monitoring of a water facility for pharmaceutical use should be discussed with methodology.
The goal is to understand all aspects of management time and resources, to identify the key steps to consider the technical aspects of design, qualifications and
monitoring of water pharmaceutical use.
After a review of the regulatory framework, the steps followed by a draft of a water facility for pharmaceutical use and the main techniques of water treatment,
participants will work on a specific case of processing water system design from the drafting of specifications to performance qualification.
They will also discuss a case of microbial contamination.
They will be invited to set up a rational investigation and will establish a working document to process results OOS approach.
Following this work in small groups, a restitution and a summary of work in the form of a flow chart will be presented.
An area for debate is also expected in order to address topics suggested by the participants themselves during the sessions.

Biarritz 2013

Workshops

Wednesday October 16th


WORKSHOP N10

Single use systems in routine production, advantages and drawbacks


A3P Representative: Patrick Turlier
Moderators: Georg Roessling - PDA et Olivier Boizet - GE Healthcare Life Sciences
1 - PDA Technical Report Single Use Systems Summary (incl. overview of the technology).
2 - Technical aspects in relation to QbD and qualification.
3 - Single Use System from the clinical trial manufacturing in view of the commercial product.
4 - Regulatory aspects and suppliers agreements.
5 - Economic aspects and risks.

WORKSHOP N11 (in french)

How to implement a matrix approach for the performance qualification of an


autoclave
A3P Representative: Patrick Hibon de Frohen
Moderators: Thomas Pothier - Rcipharm et Damien Poupry - Qualis Expertise
Qualification/Validation teams are frequently faced with a multitude of formats to qualify.
The goal of this workshop is to think about validation strategies by sharing experiences.
The case study will be based on Recipharm and Qualis Expertises experiences. Recipharm and Qualis Expertise participated in the implementation of a sterile or
final aseptic filling line for 2 ml to 100 ml vials. The aim of the workshop is to define validation strategy to optimize qualification runs.
This thought is about three types of load: - porous load (stopper), - no porous load (material), - liquid load (finished product).
The workshops participant will work on the best validation/qualification approach in line with BPF/cGMP.

20h00 Exclusive and unique Gala Dinner

www.lighthouseinstruments.com

Laser-based headspace analysis for:


Rapid non-destructive lyo
moisture determination
100% container closure
integrity testing
Non-destructive headspace
oxygen monitoring

More informations and current events


about the Congress on

www.a3p.org

Lectures
Thursday October 17th
8h00

Welcome to the participants at the Bellevue Space

9h00

Process development and manufacturing: Single Use versus Glass and Stainless Steel
Laure Valognes - Merck Biodevelopment

9h30

Innovative raw material management and product design strategy for enhanced quality, assurance
of supply, validation & change control of single use systems
Jean-Marc Cappia - Sartorius Stedim Biotech

10h00 Single-use: the right choice for Fill & Finish applications?
Florelle Tourlet - Octapharma
10h30 Break - Visit of the Exhibition
11h30 New regulatory framework for Cell and Gene Therapy
Isabelle Pautrel - CELLforCURE - Groupe LFB
12h00 Control criteria of class A/B for lling processes with terminal sterilisation
Julien Triquet - GSK
12h30 Lunch
14h00

ROUND TABLE:
Systems Ready To Use (RTU) / Single Use (SUS) for aseptic processes: what are the consequences for the product quality (particles,
leachables, relargables, others) and on sterility assurance (verication of the integrity of sterilized materials at the point of use) ?
Modication of Annex 1: the last version dated 2008 includes some
points to correct and some others to better explain. New requirements could also probably be proposed in order to include all current
aspects.
Under the supervision of Jacques Navellou (A3P) each topic will be discussed during around one
hour after a short introduction indicating some pending questions (Roland Guinet, RGmp
Compliance, A3P). The discussion will include experts on each topic either end users, speakers or
workshop leaders at the congress or ex members of NRA. The possible experts include for RTU:SUS
Dominique Sierakowski (Octapharma, A3P), Anne Rigoulot (sano pasteur, A3P) et Georg Roessling
(PDA Europe) and for the revision of Annex 1 Jean-Denis Mallet (NNE Pharmaplan), Patrick Turlier
(GSK, LEEM quality leader, A3P) and Frdric Laban (Laban Consultants). You will be able to raise
any question either during the discussion or by communicating to the Organising Comitee before
the round table.

16h00 End of the A3P Congress 2013

Congrss A3P
Congr
Biarritz - 2012

915 visites
de
congressistes
MAN
MANIFESTATION
IFESTATION

84
exposants

In 2012, the 25th International Congress A3P received


a Commercial Events Certication by the Institut Infora
589 m

d'expositions
INTER
INTERNATIONALE
NATIONALE

Biarritz 2013

Exhibition

Its still possible to take part as an exhibitor, please contact Sophie Cornu at 33(2) 38071071 or on scornu@a3pservices.com.
EXHIBITORS LIST TO DATE:

C4

C5

C6 C7

C8 C9

63
56
50
37
105
41
83
116
51-52
42
34

ERMAFLUX
36
EUROFINS
32
FURNESS CONTROLS
9
GE MEASUREMENT & CONTROL
55
GEA LYOPHIL
44
GERFLOR
30
GETINGE
107
GRONINGER & CO
11
ICARE
64
IMA France
112
INENTECH
46
INITIAL SAS
45
INTERTEK
85
JB TECNICS-Groupe JBT
C1
JCE BIOTECHNOLOGY
100-101
KIMO
31
LABORATOIRES ANIOS
15
LABWARE
118
LAPORTE EURO
114
LIGHTHOUSE INSTRUMENTS
65
LONZA
94
MERCK MILLIPORE
17-18
METTLER TOLEDO ANALYSE INDUSTRIELLE 61
MICROSCAN SERVICE
117
MRB Automatismes Industriels
C7
NNE PHARMAPLAN
104
NOVATEK INTERNATIONAL
C3
OPTIMA PACKAGING France
95
PALL LIFE SCIENCES
60-90
PAMAS
14
PARKER HANNIFIN
7

106
Kiosque 10
C8
67
111
92-93
33
88-89
C4
66
20
91
102-103
43
86
13
16
5
109

C10
104

C2
C1

116 117

103

115 114

102

101

98

70
107

69

PLUMAT

96

PMT France

40

ROBERT BOSCH GmBH

19

ROMMELAG AG

54

SAPIC

C11

SCHOTT AG

97

SCHREINER MEDIPHARM

98

SCHULKE France

84

SGS LIFE SCIENCE

99

SHIELD SCIENTIFIC

35

SKAN AG

12

SNDI ELIS

68-82

SOPAC

STERIGENE

69-70

STERILINE

10

STERIS SA

C5-C6

SWAN

113

SYMBIOSE ENVIRONNEMENT

110

TECHNIP

62

TELSTAR

87

VAISALA

115

VEOLIA WATER STI

71

WILCO AG

C2

...

15-17 octobre 2013 Biarritz

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92

91

100
82

83

84

85

86

87

88

89

90

68

67

66

65

64

63

62

61

60

108
71

50

51

52

53

54

55

56

40

41

42

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46

30

31

32

33

34

35

36

17

18

37

RIA

109

16

19

110
1

15

111
112

ROVI CONTRACT MANUFACTURING

105
106

C9-C10

PIERRE FABRE MEDICAMENT PRODUCTION 108

STAND RSERV
Occupied
space

99

118

53

PIERCAN

Exhibition map

Free
STANDspace
LIBRE

C11

C3

PHARMTEC

7 9

113
5

More informations and current events


about the Congress on

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20

5
4 6
8
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www.a3p.org

ACCUEIL

5M PARTNER
AAF
ACM PHARMA
AFTON SCIENTIFIC
ALTRAN
AMILABO
APTAR STELMI
ARECO
ASSOCIATE OF CAPE COD
AWEL INTERNATIONAL
BATIMPRO
BAUSCH ADVANCED TECHNOLOGY
GROUP-BAUSCH SWITZERLAND
BCMI Guide de l'Ultra Proprete
BECTON DICKINSON
BELIMED
BIION
BIOMERIEUX
BIOPRACTIS TRAINING CENTER
BIOQUELL
BLEZAT
BRUNO COURTOIS SA
BURKERT CONTROMATIC SAS
BWT PERMO
CHARLES RIVERS
COFELY AXIMA
COMECER
CONFARMA
CONTEC INC
DISPOSABLE LAB
ENNOV

Appointments

Do not miss it! Vinci Congress Centre in Tours, France.

18th & 19th

The biennial meeting of microbiology. The "Workshops" organized with the partner
companies will review various existing alternative techniques and present several devices.
Conferences - Workshops - Exhibition.

March

Freeze Drying meeting! Espace Tte d'Or in Lyon - France.

1st & 2nd

Second year around the Freeze drying with a refund of the work of the A3P Interest Group
(CIG A3P) and always a visit of a production site.
Conferences - Workshops - Round Table - Exhibition.

April

Now it is a convention! Espace Tte d'Or in Lyon - France.

3th & 4th

Lecture of experiences upstream downstream from opinion biotechnology leaders and


interactive workshops.
Conferences - Workshops - Round Table - Exhibition.

June

nd

July

14th to 16th
October

2014!

Particulary interesting! Pavillon des Aulnes in Vaudreuil - France.


Particules
visibles

The presence of particles of dierent natures endogenous intrinsic or extrinsic is a concern


for all industrial producing parenteral products. Presentation of the progress of the A3P
Interest Group (CIG A3P).
Conferences - Workshops - Round Table - Exhibition.

Already thinking about 2014! Bellevue Congress Hall, Biarritz- France.


A date, a place for sharing this unmissable moment for the professionals of
Pharmaceutical industry and Biotech.
Conferences - Workshops - Round Table - Exhibition.

A3P has selected hotels for you.


Best prices have been negociated by A3P,
included room and breakfast.
Find the reservation file on www.a3p.org with
the selected hotels.
We built a partnership with Tourisme
Basque which will help you with your
booking ;
the partner Agency will be pleased to advise you on your choise.

P
R
E
S
S
PA RT N E R S

24, avenue Foch 64200 Biarritz


Tl. : 05 59 24 01 10 - Fax : 05 59 26 18 82
Mail : tourismebasque@wanadoo.fr

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Registration form
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Tariffs

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2

1 275,00 without VAT

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Included membership of 180 without VAT.

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TOTAL :

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Bank transfer: Banque Populaire : N 18707/00220/07221113330/84 - Code Swift : CCBPFRPPVER


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registration and in particular to allow
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(meetings, workshops, training).

Date ........................................
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To be returned with your paiement taxes included to A3P Services - inscriptions congrs A3P - 22, rue Aristide Briand - 45220 Chteau-Renard - France
e-mail : info@a3pservices.com - Tl. +33 (0)2.38.071.071 - Fax. +33 (0)2.38.071.072
In case of cancellation received by fax or by mail, 50% of the registration will be retained and the full amount one month before the event.

More informations and current events


about the Congress on

www.a3p.org 11

altafulla - Shutterstock

Benefit from Altrans two-fold


expertise in medical devices
and pharmaceuticals to develop
your combination products.

Join Altrans conference on Tuesday 15th October


For more information, please contact Mr. Xavier Duburcq, Global Business Development Director:
xavier.duburcq@altran.com

altran.com

Note in your agenda for your french speaking people and partners some training sessions !

17 septembre 2013

18/19 septembre 2013

27/28 novembre 2013

Comment btir
un programme de
bio-nettoyage
des Salles Propres en
environnement GMP ?

Dvelopper
ses connaissances
dans le domaine
de la lyophilisation

Lannexe 1 des GMP Eu


les points critiques,
leur analyse et
leur interprtation

Animateur :
Frdric Laban
Laban Consultants
Lieu : Novotel Paris Bercy
Dure : 1 journe (8h30 - 17h30)

Animateur :
Dominique Sierakowski
Octapharma
Lieu : Novotel Paris Bercy
Dure : 2 jours (8h30 - 17h30)

Animateurs :
Frdric Laban - Laban Consultants
Roland Guinet - RGmp Compliance
Lieu : Novotel Lyon La Part Dieu
Dure : 2 jours (8h30 - 17h30)

Pour plus dinformations : A3P Formation - Tl. +33 (0)2 38 071 071 - E-mail : a3pformation@a3pservices.com - www.a3p.org

12

More informations and current events


about the Congress on

www.a3p.org

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