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white bpf GMP for biological products and advanced therapy medicines

 

BPF11      
PUBLIC
- Pharmaceutical industry or, Advanced Therapy Medicinal Products (ATMP) and associated industries producing biological products, Establishment MTI or MTI PP

- Biotechnology: production, quality control, quality assurance, technical departments, logistics and regulatory affairs

OBJECTIFS
• Understand the new regulatory requirements for organic products in GMP for France, the EU and WHO.
• Review and understand the latest decrees, regulations and recent proposals for Good Manufacturing Practice for Innovative Therapy (MTI) - Pharmaceuticals or, Advanced Therapy Medicinal Products (ATMP).

MOYENS PEDAGOGIQUES
En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.

 

PROGRAM new

DUREE
1 day


PROCHAINE SESSION
2018

FORMATEUR
Laurent LAGANIER


TARIF
800 € HT
(Déjeuner inclus)


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inscriptionbpf
This training is based on the presentation, understanding and application of the latest GMP regulatory standards for biological and biotechnological products. It includes the review of Annex 2 2014 and BPDG 2014 and WHO for BPD and heat sensitive products. The specifics of therapy drugs are reviewed and discussed with respect to their specific GMP and regulations.

EU Annex 2 2012

• Context: European legislation, why a new Annex 2, field
Application
• Presentation: common part, part specific to the different product categories
biological and biotechnological
• Conclusion: key developments and possible future changes


Innovative therapy drugs

• Background: binding regulation and its likely developments in GMP / GMP
• Presentation: the different types of MTI and MTI Prepared on a Point-by-Point basis (MTI-PP),
the hospital exemption, changes and difficulties encountered

 

Medicinal products

• Production Regulatory Requirements
• Specificity of setting up a clinical trial MTI OGM

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

Questionnaire de satisfaction

   
Cette journée s’inscrit dans le cadre de la formation professionnelle.
No Declaration: 82 69 13448 69 Pref. Region Auvergne Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025

A3P TRAINING 2018

Knowledge enhancement and its mastery

Throughout the year, A3P brings together
experts to offer you professionals quality
training sessions.

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2018 training program

 

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