Control Strategy ICHQ11

Mise en place de changement CMC post approbation pendant le cycle de vie du produit ICHQ12.

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Date

22 et 23 juin 2021

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Format

Conférences et table ronde

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Control strategy ICHQ11- Mise en place de changement CMC post approbation pendant le cycle de vie du produit ICHQ12.

Pour obtenir une qualité de produit constante, la mise en place d’une stratégie de contrôle n’est pas négociable.
Tout au long du processus de développement du produit :

  • Comment établir le profil qualité cible du produit avec les attributs qualité critiques associés?
  • Comment identifier les paramètres critiques du processus et les attributs qualité?
  • Comment maintenir le processus sous contrôle?

Ensuite, lorsque le produit est approuvé et, sur le marché :

  • Comment gérer la mise en œuvre des changements CMC post-approbation tout au long du cycle de vie du produit?

Voici les thèmes qui seront abordés lors du prochain forum A3P Suisse qui se tiendra le 22 juin (après-midi) et 23 juin (matin) 2021.

Langue officielle des conférences : Anglais
Pas de traduction simultanée des conférences 

Mardi 22 juin

Connexion des participants
13H50
Introduction
Vincent GRIFFOUL - Président A3P SUISSE
14H00
Presentation of ICHQ12 guideline and challenges
Aurélie MIEZE-RICHARD, GUERBET
A venir...
14H20
ICH Q12 : pre-requisites and success factors for implementation
Johanne PIRIOU, AKTEHOM
Pre-requisites for ICH Q12 implementation (product and process understanding, Quality Risk Management, PQS). Key concepts to identify Established Conditions: How Control Strategy and development approach influence the extent of ECs Main decision criteria to implement an ICH Q12 approach.
14H50
Pause
15H20
QbD and Control strategy – still learning!
Jennifer HALLEY, UCB
QbD process flow with do’s and don’ts! IQ Consortium on CQA’s and PCS – key takeaways from questionnaires and discussions Control Strategy is the top of the Pyramid – there are a lot of bricks holding it up!
15H30
Conclusion
16H00
Fin du webinar
16H15

Mercredi 23 juin

Connexion des participants
08H45
Introduction
Vincent GRIFFOUL, Président A3P SUISSE
08H50
Establishment of an appropriate control strategy for biotechnological products in accordance with ICH Q12
Hervé BROLY, Merck
The presentation will focus on the Merck-Serono approach for establishing an appropriate control strategy for biotechnological products. It will address the assessment of criticality of quality attributes, how to rank and select the process parameters to ensure an efficient control of the manufacturing process, and how to establish the control strategy from process design and process characterization data. Finally the presentation will discuss the application of established conditions as described in ICHQ12.
09H00
Control Strategies established and maintained using data-driven risk management
Mette BRYDER, FERRING
An efficient Quality Risk Management approach is key to establish the link from the Quality Target Product Profile to the Critical Quality Attributes and identify the critical process parameters. This presentation will illustrate how a data-driven risk assessment tool can be applied throughout the product lifecycle to: - In development: Identify critical parameters and assess sufficiency of control strategies - Post-approval: Evaluate the impact of suggested changes ensuring the process is maintained in control
09H30
Pause
10H00
How to deal with the implementation of post-approval CMC changes across the product lifecycle?
Thierry GASTINEAU, SANOFI PASTEUR
The management of CMC Post Approval Changes currently represents a huge and complex burden of activities both for the Pharmaceutical Industry as well as for Regulators. This hampers the worldwide timely and equitable access of pharmaceutical products of the highest and latest quality standards. The recent release of ICH Q12 represents a major milestone for dramatically improving this situation. In fact, ICH Q12 is the natural continuation of ICH Q9 (on quality risk management) and ICH Q10 (on the Pharmaceutical Quality System) which were published more than 10 years ago. The PDA Association has formed a “One-Voice-of-Quality” group gathering the Chief Quality Officers of 25 well-known multi-national pharmaceutical companies. This group has articulated the above 3 ICH guidelines in such a way that it allows to understand and fully realize the benefit of those guidelines in order to facilitate the implementation of lot of PACs across the product lifecycle. The presentation will aim at presenting the work done by the PDA 1VQ as well as addressing the additional challenges to still overcome.
10H10
Pause
10H40
Table Ronde
Session Q&A avec les intervenants. Retour d'expériences et partage autour des bonnes pratiques
10H50
Fin du webinar
12H05

♦ Conférenciers ♦

BROLY Hervé / MERCK

BRYDER Mette / FERRING

GASTINEAU Thierry / SANOFI PASTEUR

HALLEY Jennifer / UCB 

MIEZE-RICHARD Aurélie / GUERBET

PIRIOU Johanne / AKTEHOM 

Contact

En fonction de vos impératifs et de vos préférences, vous pouvez contacter Nina Chatré :

Téléphone : +33 7 58 68 94 49
Email : nchatre@a3pservices.com
Courrier : A3P, 30 rue Pré-Gaudry – Lyon 69007 (France)