News & Updates

Events, publications and developments, with a regulatory angle.

12 entries

NewsAug 8, 2026

QPPV outsourced: since February 2026 the contract counts, not just the person

Implementing Regulation (EU) 2025/1466 does not change the obligations on the QPPV herself. It changes what the contract with the service provider must contain and who gets audited. Buying in a QPPV no longer ends with the person.

NewsAug 4, 2026

AI Act: what applies on 2 August 2026, and what does not

On 2 August 2026 the AI Act becomes broadly applicable. The specific obligations for high-risk AI systems are not part of that: they arrive later, and for AI-based medical devices one further condition applies. Which date counts for which system, in one overview.

NewsJul 21, 2026

CPhI 2026 in Milan: Where the Operational Side of Pharma Stands

From 6 to 8 October 2026, the global pharmaceutical industry meets at CPhI Worldwide in Milan. Entourage will be on site. Three themes shape the operational agenda: Annex 1 implementation, AI readiness in the GMP environment and supply chain resilience.

NewsJun 25, 2026

BayOConnect 2026: Regulatory Strategy Determines Biotech Success

Martina Schneider (CSL Innovation / LOVEDIS) and Lena Pauli-Tzschirner (Entourage) in a live interview on regulatory strategy and startup valuation at BayOConnect 2026 in Munich.

NewsMay 11, 2026

Biosimilar Medicines Conference Amsterdam 2026: SPC Extension, Biotech Act and What It Means for Manufacturers

Two days in Amsterdam, several contentious points: the Biosimilar Medicines Conference 2026 laid bare the current flashpoints of the biosimilar industry. One topic dominated the discussion: the planned extension of the supplementary protection certificate (SPC) in the Biotech Act and what it means for the market entry prospects of the next wave of biologics.

NewsMay 8, 2026

AI Compliance in the GMP Environment: Training with the Authors of the ISPE GAMP AI Guide

How can AI systems be operated in a valid and compliant way in GxP-regulated environments? In May 2026, Entourage hosted a deep-dive training in which two of Europe's leading experts on AI compliance explained regulatory practice directly from their work developing the ISPE GAMP standards.

NewsJan 30, 2026

Entourage joins an integrated life science consulting platform

Entourage is joining an integrated consulting platform to accelerate international growth and depth of capability, while the founders retain full operational independence.

NewsJan 29, 2026

New Regulatory Update Briefing on MDR and IVDR

The EU is planning significant changes to MDR and IVDR. Our new Regulatory Update Briefing makes sense of the current proposals, from product delineation to integrated products.

NewsJan 28, 2026

DCAT Week 2026: insights and exchange in New York

DCAT Week 2026 in New York was once again one of the most important meeting points of the international pharma and biotech industry. Entourage was there, in exchange along the global value chain.

NewsNov 29, 2024

Entourage is a Top-Arbeitgeber Mittelstand 2025

FOCUS-Business has again named Entourage a Top-Arbeitgeber Mittelstand 2025, a confirmation of an attractive working environment in the life science sector.

NewsMar 11, 2022

Entourage in Milan: our location in Italy

With Entourage Italy S.r.l. in Milan, Entourage has a firm presence in the Italian market, one of the most exciting markets for the life science industry in Europe.

NewsMar 5, 2021

Entourage is a member of the MedTech cluster Medical Valley

Entourage is a member of the medical technology cluster Medical Valley Hechingen, a network of companies, suppliers, service providers and universities in the MedTech and biotech sector.

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