EU GMP Annex 1: New Standards for Injectable Drug Manufacturing

April 8th 2025 – 4pm (CET) / 10am (ET)

EU GMP Annex 1: New Standards for Injectable Drug Manufacturing

April 8th 2025 – 4pm (CET) / 10am (ET)

Addressed Challenges

  • Contamination Control Strategy
  • Best Practices for Aseptic Transfer
  • Sterility of Primary Packaging Components

What You Will Learn

  • Gain insight into the EMA Annex 1 Revision, including its context and scope
  • Explore the involvement of suppliers and primary packaging within Annex 1
  • Learn how Aptar Pharma’s solutions support drug manufacturers in complying with Annex 1

Estelle Verger

Senior Manager, Business Development, Aptar Pharma

Estelle Verger is the Business Development Senior Manager for PremiumCoat® coated solutions for Aptar Pharma’s Injectables division, and is responsible for the growth of the PremiumCoat® platform in the global injectable market. A graduate from ESSEC Business School and Fachhochschule Dortmund, with a Masters degree in International Business Management, she joined Aptar Pharma in 2011 as a Sales Manager, Injectables. Estelle then moved to Aptar Pharma’s Consumer Healthcare division as a Product Manager, where she was responsible for Airless Dispensing Solutions for pharmaceutical applications for a number of years, before returning to the Aptar Pharma Injectables division in 2020.
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Wendy Durand

Senior Manager, Regulatory Affairs

Wendy Durand is a Senior Manager Regulatory Affairs at Aptar Pharma’s Injectables division. In her role, Wendy focuses on ensuring compliance with regulatory requirements, product quality, and safety. She has experience from previous roles in various pharmaceutical companies. She is a pharmacist with a Master's degree in Analytical Chemistry from Bordeaux University. She joined Aptar Pharma in 2020.
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