The FDA’s Advanced Manufacturing Technologies Designation Program

The Advanced Manufacturing Technologies Designation Program aims to accelerate the implementation of novel manufacturing technologies and the application of existing ones to new contexts of use. The FDA Guidance for Industry, published at the beginning of January 2025, describes the entire process of submitting a request for AMT designation and its contents

"E.I.P.G. is a European association representing the national, professional organizations of pharmacists
employed in the pharmaceutical or allied industries of the Member States of the European Union,
the European Economic Area, or European countries having a mutual recognition agreement
with the European Union on compliance control of regulated medicines."

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Presentations

Our media library contains an extensive collection of presentations by EIPG Bureau members or delegates, and presentations made at Scientific Symposia.
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Position Papers

EIPG issues comments and feedback in response to consultation documents and white papers released by the European Medicines Agency and the European Commission.
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Education

EIPG’s initiatives dedicated to industrial pharmacist education, including the EU-funded projects MOGLYNET, PHAR-IN and PHARMINE.
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Members’ Area

Member organisations can sign in here to get even more information regarding EIPG’s projects and works.
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The EU’s Competitiveness Compass and the new EU Biotech Hub

The Competitiveness Compass describes the new European Commission’s political actions to fill the gap with international competitors, support the transition to clean and digital technologies, and reduce supply chains’ dependencies in strategic sectors. Among these are also biotechnologies and more extensively, life sciences.
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The EU AI Act: compliance obligations and business opportunities in 2025

As of February 2, 2025, the first binding provisions of the European Union's AI Act have come into force, marking a crucial milestone in AI regulation. European companies must comply with bans on unacceptable AI practices and implement AI literacy programs for their employees. This article examines the February 2025 updates, their impact on businesses, and the strategic opportunities arising from compliance
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PIC/S’ new guidances on remote and hybrid inspections

Two new guidance published by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) discuss the different types of remote assessment, including hybrid inspections, and provide a harmonised approach to their conduct. The PIC/S also revised its guideline for the accession to the Scheme by interested regulatory agencies
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ICH E6(R3): a new era for Good Clinical Practice in industrial pharmacy

The latest revision of the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), ICH E6(R3), represents a significant advancement in the regulation of clinical trials. This update introduces a modernized, risk-based, and flexible approach to trial conduct, aiming to enhance data integrity, patient safety, and operational efficiency. This article examines the key changes in ICH E6(R3), focusing on its impact on industrial pharmacists involved in clinical research and drug development.
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