Events

Lean Lab 2026

Fabiana Nichetti — Thu, 24 Sep 2026 09:58:30 GMT

Lean Lab started in 2009 with a simple premise: the people working inside Life Sciences laboratories have experiences worth sharing, and the industry learns better when those experiences are put in the same room.

Lean Lab 2026: Laboratory Transformation

Fabiana Nichetti — Fri, 31 Jul 2026 04:00:00 GMT

The laboratory of a few years ago barely resembles the one organisations are building today

The conversation in Life Sciences laboratories has shifted. It is no longer about whether to digitise, automate or adopt AI. It is about how to do all of it at the same time, without losing compliance, operational continuity or the people who make it work.

Europe's HTA Shift and JCA Readiness for Chinese Biopharma

Fabiana Nichetti — Tue, 26 May 2026 04:00:00 GMT

As the EU's Joint Clinical Assessment (JCA) begins to reshape how innovative therapies are evaluated across Europe, the implications for companies entering the region are becoming increasingly concrete and increasingly difficult to defer.

AI-Driven Data Migration & Integration in Life Sciences

Fabiana Nichetti — Tue, 03 Mar 2026 05:00:00 GMT

ONLINE EVENT

Data migration and system integration in Life Sciences have followed familiar patterns for more than two decades. Yet today, the landscape has fundamentally changed. The rapid expansion of SaaS platforms, cloud-based environments and digital tools has made data easier to generate - but significantly more fragmented, decentralized and complex to manage.

Scaling Small Pharma & Biotech: People and Process Strategy

Fabiana Nichetti — Tue, 03 Mar 2026 05:00:00 GMT

ONLINE EVENT

Growth in emerging pharma and biotech does not happen by chance. It is the result of disciplined execution, strong leadership, and operational foundations capable of sustaining increasing complexity.

Quality & Manufacturing Connect: Digital Innovation in Life Science

Fabiana Nichetti — Mon, 23 Feb 2026 05:00:00 GMT

As digital transformation continues to reshape the life sciences industry, organizations are rethinking how quality, manufacturing, and supply chain functions operate within increasingly complex and regulated environments.

EU PACMP Under ICH Q12: Smarter CMC Change Management

Fabiana Nichetti — Wed, 18 Feb 2026 05:00:00 GMT

ONLINE EVENT

As post-approval CMC changes continue to increase in complexity and regulatory scrutiny, companies must find ways to maintain compliance while ensuring supply continuity and lifecycle agility. Under ICH Q12, the Post-Approval Change Management Protocol (PACMP) offers a structured and predictable pathway to plan and implement certain CMC changes within the EU regulatory framework, reducing uncertainty and enabling more efficient execution.

IVDR 2025 Proposal: Reassessing Your Compliance Strategy

Fabiana Nichetti — Wed, 18 Feb 2026 05:00:00 GMT

ONLINE EVENT

The IVDR transition continues to evolve, and 2026 represents a pivotal moment for manufacturers to reassess their regulatory roadmap. Regulation (EU) 2024/1860 extends the transition period for eligible legacy devices, offering companies additional time to achieve compliance. However, while the timeline has shifted, the core IVDR requirements remain unchanged. At the same time, the targeted 2025 revision proposal introduces new strategic considerations that may influence long-term portfolio and compliance planning.

EMA Revised ERA Guideline: Practical Insights One Year On

Fabiana Nichetti — Mon, 26 Jan 2026 05:00:00 GMT

ONLINE EVENT

In February 2026, ProductLife Group will host a focused webinar dedicated to the practical application of the revised EMA Environmental Risk Assessment (ERA) guideline, one year after its implementation.

Global Dietary Supplements Regulatory Updates

Fabiana Nichetti — Mon, 26 Jan 2026 05:00:00 GMT

ONLINE EVENT As regulatory expectations for dietary supplements continue to evolve worldwide, companies operating internationally must navigate increasingly complex and region-specific requirements. Staying aligned with regulatory developments across key markets is essential to ensure compliance, manage risk and support successful global expansion. In this ProductLife Group webinar, our experts will share practical insights into the latest regulatory updates affecting dietary supplements in 2025, with a forward-looking perspective on strategic considerations for global market entry as we move into 2026. The session will explore:

Key regulatory hotspots and watchpoints across the U.S., Europe, Asia and Latin America
Practical approaches to reduce regulatory risk when launching products internationally
Strategic guidance to strengthen compliance planning and support efficient global market access

Designed for regulatory and quality professionals, this webinar aims to help teams anticipate regulatory change, structure robust international strategies and navigate complexity with confidence in an evolving global landscape.

Speakers

Merve Çiftci Kantar, Regulatory Affairs Project Expert