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Blog

_Blog

Implementation of ICH Q12 in Europe: where are we now?

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March 5, 2026
_Blog

Centralised Procedure

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February 13, 2026
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Do “over the counter” medicines exist in France?

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February 13, 2026
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Clinical Trials versus Research Involving Human Subjects (RIPH): How Are Pharmaceutical Companies Affected?

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February 3, 2026
Comprendre EUDAMED
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Understanding EUDAMED: The European Database on Medical Devices

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January 28, 2026
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New ICH M4Q(R2) guidelines: towards a paradigm shift for Module 2.3 and 3 formats

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January 16, 2026
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The Post-Approval Change Management Protocol or “PACMP” 

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January 6, 2026
MPUP Non GMP
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How to manage a non-GMP raw material in your MA files? 

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December 23, 2025
Prescription et délivrance
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Conditions for the Prescription and Dispensing of Medicines in France

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December 4, 2025
Rétrocession
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The Hospital-to-Community Dispensing (“Retrocession”) of Hospital Medicines to Outpatients in France

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December 1, 2025
PCVRR
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The PRRC: Person Responsible for Regulatory Compliance 

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December 1, 2025
Extension d'AMM versus variation de type II
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Marketing Autorisation Extension versus type II variation. 

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November 12, 2025
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