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CO-LOCATED EVENTS

Speaker

Jyotsna Agnihotry

Head of QA and Regulatory Affairs, Flavine Europe

A seasoned expert in pharmaceutical quality, compliance, and supply chain integrity, this speaker brings over 15+ years of hands on experience in the global pharmaceutical and life sciences industry. With a strong foundation in GMP, GDP, and regulatory compliance, currently leads operations at a European pharmaceutical firm specializing in the sourcing, qualification, and distribution of active pharmaceutical ingredients (APIs). Certified in Six Sigma and ISO quality systems, has a proven track record of implementing effective quality management frameworks, managing inspections, and driving audit readiness across complex global supply chains.

A recognized industry trainer and consultant also has contributed to numerous cross-border initiatives involving serialization, cold chain management, and data integrity solutions. Their work bridges regulatory expectations with operational realities, offering practical strategies for safeguarding product quality from manufacturing through distribution. With a deep commitment to continuous improvement and is a respected voice in industry forums and brings a unique blend of technical rigor, regulatory insight, and leadership to every engagement.

The Pop in Your Job: What excites me most about my work is the challenge of navigating complex compliance landscapes and transforming regulatory requirements into efficient, workable quality systems. I enjoy identifying gaps, streamlining processes, and ensuring that every part of the operation aligns with global GMP and GDP standards. There’s a unique satisfaction in leading audits, solving quality issues, and fostering a mindset where compliance is viewed as a value-add, not just a regulatory obligation. I’m driven by the opportunity to influence systems and cultures where quality is built in from the start, and continuous improvement becomes part of daily operations. It’s this ability to blend structure, strategy, and real-world execution that makes my role so rewarding.

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Session

Securing the Supply Chain — Leveraging Serialization, Data Loggers, and Predictive Analytics to Combat Counterfeiting and Ensure Product Integrity

Case Study

Tuesday, September 23

09:30 am - 09:55 am

Live in Berlin

Less Details

This session explores how the integration of serialization technologies, real-time environmental monitoring, and predictive analytics can significantly strengthen supply chain transparency and resilience. Attendees will learn how environmental factors—such as temperature fluctuations and ink durability—can compromise serialized data and product quality, and how innovative risk mitigation approaches can prevent counterfeiting and ensure product integrity from production to patient. In this session, you will learn how to:

  • Identify key environmental and operational risks that affect serialized product data and supply chain integrity.
  • Apply predictive analytics and data logger technologies to proactively detect and mitigate threats.
  • Integrate serialization and real-time monitoring tools to safeguard product quality and traceability across the supply chain.
Presentation

Company

Flavine Europe

Since 1975, Flavine International has been linking advanced API manufacturers with markets and pharmaceutical companies. We are thriving to add value to the business of both suppliers and customers by locating and developing quality manufacturers and opening up new markets. As a GMP certified company we also have our own laboratory control for QP release of finsihed product & API.
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Colocated with
Pharma MES Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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