IMP Labeling Workflows That Reduce Relabeling Risk and Start-Up Delays

Investigational medicinal product (IMP) labeling sits at the heart of clinical trial supply, impacting departments across pharmaceutical organizations, from clinical operations and regulatory affairs to quality assurance and beyond. When labeling activities are managed across multiple systems, vendors and stakeholders, teams often face avoidable rework, conflicting label text versions, delayed translations, unclear approval pathways and change control gaps that can delay site activation or trigger costly relabeling.

This webinar will share firsthand experiences in centralizing the IMP labeling workflow to create a single, controlled pathway from label content creation through translation, regulatory alignment, artwork, proofing, print, release and distribution. The featured speakers will outline practical operating models that improve visibility and accountability. These include defining a “single source of truth” for label text, standardizing templates and phrasing libraries, establishing clear review and approval roles and building timelines that account for country-specific requirements.

Attendees will learn how centralized workflows can reduce cycle times while strengthening compliance, particularly for multilingual labeling, updates driven by amendments and global studies with staggered country start-ups. Real-world pitfalls and proven controls will also be covered, including versioning rules, translation handoffs, audit-ready documentation and KPI tracking to help prevent last-minute firefighting.

Register for this webinar to learn how labeling workflows can reduce IMP errors, strengthen compliance and support faster study start-up.

Speakers

Amalie Engemand Henriksen, Director, Global Clinical Drug Supply, Genmab A/S

Amalie Engemand Henriksen is the Director of Global Clinical Drug Supply at Genmab A/S. With over 10 years of GxP experience, she has extensive expertise in clinical trials and handling of investigational medicinal products (IMP) across site pharmacies, CMOs and sponsor organizations.

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Sandeep Anne, Senior Director, Head of Clinical Trial Supplies, Jazz Pharmaceuticals

Sandeep Anne is the Head of Clinical Trial Supplies at Jazz Pharmaceuticals, bringing over a decade of experience in clinical supply strategy and operations, with leadership expertise spanning both global pharmaceutical companies and emerging biotech organizations, including Genentech, GSK and Taysha Gene Therapies.

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James Bardsley, Independent Consultant

James Bardsley is a supply chain professional with over 25 years of experience across multiple industries, including metal fabrication, medical devices, polymer production and—most significantly—clinical supply. He consistently adds value by improving operational efficiency, building strong cross‑functional relationships and establishing reliable, repeatable processes that reduce waste and enhance performance.

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(Moderator) Alyssa Ogunnowo, Director of Label, Regulatory and Medical Writing Solutions, TransPerfect Life Sciences

Alyssa Ogunnowo is the Director of Label, Regulatory and Medical Writing Solutions at TransPerfect, where she consults with global pharmaceutical and CRO partners on change transformation across clinical trial supply operations. With eight years of experience focused on translating regulatory policy and language requirements into business-driven practices, Alyssa specializes in workflow development and management, QA procedures and risk-implication validation to support scalable, compliant delivery models. Her work spans client services and business consulting, helping teams centralize processes and adopt new technologies, including AI, without sacrificing governance or quality.

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