Congress A3P Morocco
BPD - Serialization - ICHQ12 - Inspection - Cleaning Validation - Process Control

Place

Hotel Sofitel - Marrakech - Morocco

Dates:

4 & 5 April 2019

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Conferences - Exhibition - Workshops

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Since 2004, A3P Morocco (Association for Clean and Sterile Products) has the major objective of being a real place of exchange and meeting between the manufacturers of the pharmacy sector and their suppliers in Morocco.

The office A3P Morocco brings together a college of manufacturers and a college of suppliers from Moroccan industries.

Its annual congress, thanks to this peculiarity becomes in fact the essential pharamaceutical event.

For two days, it brings together all the professionals of the sector.

Its conferences, all related to current topics and its unique workshop format allow to discuss regulatory and technical issues of production and control in direct relationship with the professional daily. An exhibition allows each of the suppliers and service providers to be the technological showcase of reference in its field.

The conviviality of the association and the organization of the sessions bring the comfort and the serenity necessary for fruitful exchanges.

Official language of conferences: Français

Thursday April 04 2019

Welcome of participants
08:30
Introductory speech
Yasmine Lahlou Filali
President A3P Morocco
9:00
The human being, a competitive asset and a lever of success in a changing world
Dominique Ben Dhaou
Point North
9:15
Good distribution practices, how to ensure the traceability of medicines
Dr. Aicha Bamou
Department of Medicine and Pharmacy - Ministry of Health
09:45
Break and exhibition visit
10:15
Serialization: feedback
Mohamed Ali Akkari
A3P Scientific Committee Tunisia
10:45
Role of pharmacoeconomics in the evaluation of health products
Pr Samir Ahid
Mohammed V University of Health Sciences
11:15
Inspection of manufacturing sites by health authorities, difference between European sites and other sites
Jean Francois Mackowiack
Axys network
11:45
Lunch break
12:15
First part of the workshops
14h00
Break and exhibition visit
15:30
End of the first day.
17:00

Friday April 05 2019

Process validation integrated into the product life cycle: a rational and scientific approach to improve process knowledge, control and performance and to obtain reliable and quality products.
Anne Rigoulot
Sanofi
9:30
Design of the Cleaning and Disinfection Life Cycle Program in accordance with Draft GMP Annex 1
Walid El Azab
Steris
10:30
Break and exhibition visit
11:00
ICHQ12 - Context and Impact.
Nadia Beaudoux
Lilly
11h30
Lunch break
12:00
Workshops second part
14:30
Break and exhibition visit
15:30
Closing of the 10 Congress A3P Morocco
16:30
Cleaning Validation
Pierre Devaux - Theraxel point forty five
L'atelier fera le point sur les dernières évolutions réglementaires et reviendra sur le document suivant publié par l'EMA en avril 2018 "Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)". L'atelier proposera plusieurs exercices pour expliquer la gestion de la validation du nettoyage sur une ligne de fabrication fictive multi produits de liquides injectables lyophilisés combinant des produits hautement actifs et des produits "non à risques". Quelles sont les surfaces à risques? Quels traceurs retenir? Où? Quels critères? Comment prélever? Combien d'essais de validation? Cet atelier vous donnera des outils décisionnels pour réaliser vos stratégies.
1 workshop
Application of the validation approach of an integrated process around a concrete case with the 3 major steps
Anne Rigoulot - Sanofi
 Step 1: definition of the industrial process. Implementation of the criticality analysis approach for the definition of critical quality attributes and critical parameters including the identification of the elements to be put in the regulatory file  2 step: process validation: Definition of a protocol reproducibility and comparability study including the analysis of the results in case of anomaly and the statistical analyzes of comparability.  Step 3: continuous verification: Definition of the verification protocol of the previously validated process including statistical analysis and associated tools (control charts, capability indices, MSP).
2 workshop
Microbiology in water treatment systems: how to master it through design and follow it through analysis
Jean-Jacques Petit - BWT
Production and distribution of purified water and PPI water: good design practices to prevent the risk of bacterial contamination. Analytical methods: comparative classical methods and online analysis for bacteriological control of pharmaceutical waters.
3 workshop
serialization
Mohamed Ali Akkari & Dr Aicha Bamou - Unimed - DMP
Gestion d’un projet de sérialisation a- La contrefaçon des médicaments b- Aspect Réglementaires de la sérialisation c- Stratégie d’entreprise relative à la sérialisation d- Mise en place d’un projet de sérialisation : Eléments clés
4 workshop
Data Integrity
Anne Sophie Deschamps - Altran
Data integrity : 1-Comment déterminer le périmètre 2-Quelle méthode choisir lors de la mise en œuvre 3- Comment faire le lien entre la data integrity et la GMP Compliance.
5 workshop

You wish to reserve a stand, please consult our exhibitor file

Download the exhibitor file in euros

Download the exhibitor file in dirhams

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
17
28
3 BWT MOROCCO9
ASSOCIATES OF CAPE COD410
5 BIOQUELL11
STERIGENE6 ROMMELAG 12

Benefits included with the table top

  • A dedicated exhibition space where you can install your products and communication tools: roll-up, display ...
  • A basic endowment including 180 x 80 cm table, 2 chairs and 1 electrical connection (16A, 300 kw) without protective breaker
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (590 € HT)

Event Registration Form

At the end of this form you will receive a copy by email of the information provided.

Registration







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Contact

Depending on your requirements and your preferences, you can contact:

A3P Morocco: Mrs. Benjelloun Dounia

Phone: 00 212 661 357 957
E-mail : info.a3pmaroc@gmail.com
Mail: A3P Morocco, 27 street Socrate Maarif - 20380 Casablanca - Morocco

A3P Services: Mrs. Hamriche Salima

Phone: 0033 4 37 28 30 40
E-mail : shamriche@a3pservices.com
Mail: A3P Services, 30 rue Pré-Gaudry - Lyon 69007

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