Pharmapack announce key themes for Pharmapack Europe 2020

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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Connectivity, customization and sustainability are driving pharmaceutical packaging and drug delivery innovation at Pharmapack Europe (#pharmapackeu), which opens in February 2020. The event is the leading exhibition dedicated to pharmaceutical packaging and drug delivery devices, with major industry players set to come together to discuss vital best practices, insights and strategies.

“This year’s Pharmapack Europe agenda highlights what an interesting time it is for packaging and drug delivery, showcasing the full depth and breadth of developments anticipated in the upcoming year,” says Silvia Forroova, Brand Director at Pharmapack Europe. “Most excitingly, our speakers feature some of the industry’s most prominent experts, leading pharma companies and new start-ups delivering tomorrow’s vital innovations. Pharmapack Europe is a content-rich experience and the premier business platform for executives looking for new partners to drive forward tomorrow’s approaches in drug delivery and packaging”.

Pharmapack Europe will host four themed conference sessions and a number of educational and interactive workshops and learning labs, with the event featuring more than 45 unique sessions, including keynotes from leading pharma companies, promising start-ups and knowledge partners.

The connectivity and patient-centricity session will explore the effects of digitalization and disruptive technologies on packaging and drug delivery devices, and includes Aurelio Arias, Senior Consultant, European Thought Leadership, IQVIA speaking on “Digital Value-Added Medicines”.

In another highly anticipated session on sustainability, speakers will assess eco-friendly and energy-efficient packaging with the goal of reducing life-cycle and environmental impact. Fabien Thibault and Corinne Ondo of Merck Group will put forward their company’s strategies for improving packaging sustainability by adopting the use of recyclable materials, while also cutting down on energy, space, and overall material usage in packaging production.

Within the Challenges in Drug Delivery for Biologics session, the focus will be on how companies are developing advanced delivery technologies to cater for the greater sensitivity of biologic drugs.

The ‘New Horizons in Innovation’ session will address the challenge in bridging the development gap between clinical and commercial applications as more innovators come to market, and how scale-up challenges will continue to present a significant barrier for the industry to overcome in order to fully reach its potential. This session also features the Pharmapack Awards 2020 winners’ presentation.

Several Learning Lab workshops will also be held throughout the two-day event, covering a breadth of topics within pharmaceutical packaging and drug delivery – from the impact of medical device regulation in the industry and polycarbonate innovations for novel drug delivery devices to an evaluation of current and future delivery strategies.

These workshops will provide attendees ample opportunity to interact with exhibitors on a more personal level and gain insight into industry trends that are of most relevance. They will include practical examples from specialists such as Haselmeier, Aptar, Graphic West Biocorp and others.

Finally, entries for the 2020 Pharmapack Awards are now open across both the ‘Exhibitor Innovation’ and ‘Health Products’ categories, with a closing date of 6th November 2019. The Health Products category will include two winners with one for Patient-Centric Design – which is launched in partnership with HCPC Europe (Healthcare Compliance Packaging Council of Europe) – and a second introduced alongside Adelphe and HPRC (Healthcare Plastics Recycling Council) for Eco-design in health packaging and drug delivery devices.

The event will be held at the Porte De Versailles in Paris (5-6 February, 2020) and is the leading hub for stakeholders across all parts of the pharmaceutical packaging and drug delivery supply chain, with over 5300 attendees and 400+ exhibitors from 75 countries expected to be present.

Session 1 Connectivity and Patient-centricity on 5th February Morning:

  • “Digital Value-Added Medicines” by Aurelio Arias, Engagement Manager, European Thought Leadership, IQVIA
  • “Ensuring our digital solutions truly deliver value” by Paul Upham, Head, Smart Devices, Roche/ Genentech
  • “Packaging: Labeling setup requirements for, and experiences with, clinical trials and post-market surveillance of pharmaceuticals in relation to patient therapy compliance” by Guillaume Bonafous, Industrial project leader, Sanofi
  • “Risks and real-world issue with connected devices” by Tom Oakley, Director of Drug Delivery Device Development, Springboard

Session 2: Sustainability on 5th February afternoon:

  • “HPRC (Healthcare Plastics Recycling Council): A Collaborative, Value Chain Approach to Enabling Plastic Recycling”by Juha-Pekka Pöyry, Technical Marketing Specialist, DuPont™ Tyvek® Healthcare Packaging
  • “Recovering and managing waste generated by used medicines in the health and medico-social sector” by Valérie Tatin, Purchasing Manager, Korian
  • “Starting at the source, sustainable packaging in Merck supply chain” by Fabien Thibault, Global Manager, Product and Packaging Sustainability, and Corinne Ondo, Associate Director, Head of Sourcing Glass, Merck Healthcare
  • “Implementing circular product design on the journey towards zero environmental impact” by Nanja Hedal Kløverpris, Project Lead, Corporate Environmental Strategy, Novo Nordisk A/S
  • “Medical blister recycling challenges: first steps into action” by Delphine Pernot, Eco-design services Manager, Adelphe
  • “Preparing for the Black Swan: A Playbook for Exiting PVC in pharmaceutical flexible packaging” is covered in a presentation by Peter J. Schmitt, Managing Director & Co-Founder, Montesino Associates, LLC

Session 3 Challenges in Drug Delivery for Biologics on 6th February morning:

  • “How Formulation Triggers Device Development” by Christian Dechant, Director Primary Packaging Development Biologicals, Pharmaceutical Development Biologicals, Boehringer Ingelheim
  • “The Dermal Filler market and its manufacturing challenges” by Frederic Bertaïna, CEO, Bioxis Pharmaceuticals
  • “From Primary Container to Device Development – pitfalls and ways to maximize efficiency” by Michael Song, PhD, Senior Manager, Biopharmaceutical Development, Dosage Form Design & Development, AstraZeneca
  • “Harmonizing Cost and Microliter Dosing Performance Requirements – Applications in Ophthalmology, Oncology, Cell & Gene Therapy” by Dr. Gautam Shetty, CEO, Congruence Medical Solutions LLC (a US start-up company)

Session 4 New Horizons in Innovation:

  • “Change as a prerequisite to enhancing innovation capabilities for organizations” by Marc Rohrschneider, Head New Technologies, Device Development and Commercialisation, Novartis AG
  • “Using Blockchain across the Pharmaceutical Supply Chain” by Jason Lacombe, Chief Executive Officer, Veratrak (a UK start-up company)
  • “Big Data in pharma cold chain logistics: the key to mitigate risks and reduce cost” by Marrie Groeneveld, COO, SkyCell
  • Pharmapack Awards 2020 winners’ presentation

About Pharmapack

Launched in 1997, Pharmapack is the European event for Pharmaceutical Packaging, Drug Delivery, Medical Devices and Machinery. Pharmapack started as a biennial conference and exhibition, taking place every other year in Paris, until industry developments demanded a more frequent event to help the industry stay up to date on the latest trends, developments and regulations. In the past 20+ years, the event has grown from a conference with a small table-top exhibition, to an event hosting 411 exhibitors and welcoming 5,290 attendees over 2 days. In 2018, Pharmapack also featured the International Meetings Programme (business matching), an International Meetings Programme, full 2-day Conference, 1-day Symposium, Workshops, Learning Lab presentations, Awards ceremonies, a Start-up Hub, Innovation Gallery and Tours.

About Informa Markets

Informa Markets creates platforms for industries and specialist markets to trade, innovate and grow. Our portfolio is comprised of more than 550 international B2B events and brands in markets including Healthcare & Pharmaceuticals, Infrastructure, Construction & Real Estate, Fashion & Apparel, Hospitality, Food & Beverage, and Health & Nutrition, among others. We provide customers and partners around the globe with opportunities to engage, experience and do business through face-to-face exhibitions, specialist digital content and actionable data solutions. As the world’s leading exhibitions organiser, we bring a diverse range of specialist markets to life, unlocking opportunities and helping them to thrive 365 days of the year. For more information, please visit www.informamarkets.com.

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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