News & Updates

Events, publications and developments, with a regulatory angle.

16 entries

NewsSep 4, 2026

RAPS AI in Regulatory Conference 2026: Entourage Is in Barcelona

On November 5 and 6, 2026, RAPS brings regulatory professionals to Barcelona to look at what artificial intelligence is doing to regulatory work. Entourage is there on both days.

NewsAug 28, 2026

DCAT Week 2027 in New York: Entourage Will Be on Site

From March 15 to 18, 2027, the international pharma supply chain meets in New York for DCAT Week. Entourage will be on site with Andreas Weirich and Moritz Haucke.

NewsAug 18, 2026

Three cyber deadlines hit the same teams, and the first one has already passed

September 11 and 12, 2026, are one day apart. The first starts the reporting obligations under the Cyber Resilience Act, the second brings the Data Act design obligation to bear on newly placed connected products. The third deadline is not a coming one: the German NIS-2 implementing act has applied since December 2025.

NewsAug 15, 2026

Signal management: two changes have applied since August 2025, not since February 2026

Implementing Regulation (EU) 2025/1466 is usually reduced to a single date: February 12, 2026. Two of its changes have applied since August 12, 2025, and both sit in signal management. One of them deletes an obligation on the marketing authorisation holder.

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 August 2, 2026, and what does not

Since August 2, 2026, the AI Act has been 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 October 6 to 8, 2026, the global pharmaceutical industry met at CPhI Worldwide in Milan. Entourage was on site with a team. In our view, 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 AI compliance experts explained regulatory practice directly from their work developing the ISPE GAMP standards.

NewsMar 27, 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 conversation along the global value chain.

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 European Commission has put forward significant changes to MDR and IVDR. Our new Regulatory Update Briefing makes sense of the current proposals, from product delineation to integrated products.

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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