Regulations & quality and bioproduction

Level 2 -

Hands-on application of Quality by Design using a specialized platform

Presentation

Why participate?

Demystify and understand the Quality by Design approach, and gain enough knowledge to improve interactions with pharmaceutical companies, increasing your chances of partnership or out-licensing.

Training Context:

Quality by Design is an increasingly applied, innovative methodological approach in pharmaceutical companies. It is essential for controlling product quality parameters and, above all, for building a robust development plan.
Understanding this approach is crucial for anticipating process transfer within an overall quality framework — and identifying the key elements needed to do so.

Learning objectives

  • Recognize the need for a multidisciplinary QbD approach: process development, analytical development (PAT and in-line measurement), quality assurance, and regulatory affairs
  • Apply Quality by Design easily using a specialized platform: Practical application through a case study. The case study can be adapted to participants’ profiles — please contact us in advance to let us know your specific needs.

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Analytical R&D and QC, QA team leaders, CMC regulatory affairs writers, project managers, researchers, process development engineers and technicians

Prerequisites

Fundamentals in biotechnology, solid knowledge of biopharmaceutical development. A good understanding of the Quality by Design (QbD) approach or prior completion of Module 1: "Fundamentals for Implementing a Quality by Design Approach to Strengthen Your Company’s R&D."

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

Includes 6 months of free access to the easyQBD platform, with a user guide and expert tips

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Trainers

Catalogue de formations-MabDesign-2023.pdf

Thierry

BASTOGNE

CSO CYBERnano
CYBERnano
Professor
Research Center for Automatic Control of Nancy (CRAN), University of Lorraine, CNRS UMR 7039, SBS Department (Health, Biology, Signals)

Rating

There is no rating available because this training session was never carried out.

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr

Jean-Roch Fabreguettes

MEARY

Directeur Médical et Personne Responsable du Centre MEARY de thérapie cellulaire et génique au sein de l’hôpital Saint-Louis à Paris

Jean-Roch Fabreguettes est un spécialiste de la recherche translationnelle et des phases précoces de développement clinique des médicaments de thérapie innovantes (MTI). Pharmacien, titulaire d’un doctorat de l’Université de Montpellier 1, il a travaillé plus de 25 ans dans le domaine et a contribué, pour des équipes académiques comme pour des start-ups, à la réalisation de plus de 30 programmes de recherche sur différents types de MTI : thérapie génique in vivo ou ex vivo, thérapie cellulaire, ingénierie tissulaire… Il est actuellement Directeur Médical et Personne Responsable du Centre MEARY de thérapie cellulaire et génique au sein de l’hôpital Saint-Louis à Paris. Le centre MEARY est une plateforme de l’Assistance Publique – Hôpitaux de Paris (AP-HP), dédiée à la fabrication de médicament de thérapie innovante expérimentaux. Laboratoire membre de l’ISCT, il est autorisé par l’ANSM et dispose d’un certificat GMP. A ce titre Jean-Roch Fabreguettes est impliqué dans le développement clinique et la fabrication de nombreux MTI : CAR-T cells, lymphocytes T régulateurs, cellules stromales mésenchymateuses…

Précédemment, Jean-Roch Fabreguettes a été expert Qualité (CMC) auprès de l’ANSM durant 9 ans et a conseillé différentes sociétés de biotechnologies. Il est un intervenant régulier pour l’Université Paris Cité et un membre actif de l’ISCT et de réseaux nationaux et internationaux sur les MTI (UNI-TC, Join4ATMP).