Welcome to PDA Miniverse: Medical Devices, Combination Products and Connected Health Conference 2025
We caught up with co-chair Maggie Bandel, MBA, Global Head, Lifecycle Management MSAT at Johnson & Johnson for a behind-the-scenes preview of how the Miniverse fills a gap in the pharma conference space. As a side note, she is especially qualified in her professional work helping shape the future of the industry. She says her focus is on “Driving key peer-to-peer learnings across the industry and leveraging best practices from one segment to another! Some of the best advances in a field are from innovating from outside of that field.”
She reports, “The Miniverse has been years in the making. With the rise of combination products in pharma, we saw a fundamental shift in the content and topics the industry was looking for. The larger PDA Universe event is one of the most well-attended events, and we wanted to be able to host a smaller event in advance of the Universe for those who can't attend the larger event in Vienna.” She adds, attendees will be in good company, “The Miniverse has a unique blend of large pharmaceutical professionals, leading industry experts, and service providers with rich insights and case studies that can be shared.
Developing a relevant and actionable agenda is a challenge and an opportunity. Maggie explains, “We will bring keen insights on trends based on what people are asking for help with. It’s a fusion of hot topics and critical updates on the basics. Attendees can expect deep insights into common challenges across the industry. In other words, you are not alone in your problems, and we are here to help you -- and learn from you! Networking will be a key attraction for attendees as they can talk to peers in the industry about common pitfalls, and challenges, and share lessons learned.” The Miniverse is designed for the peers who will be attending the highly focused program. Maggie describes a great pharma event as one that is centered on the attendees. She says, “We have gathered a terrific panel of presenters and industry leaders to put together a wonderful event, but your participation and insights as an attendee are even more valuable.”
Understandably Maggie is most looking forward to launching an event that has been over five years in the making. If you are sitting on the fence about attending, she says, “This is a great opportunity for those based in the US who cannot travel to the EU Universe event. We specifically created this conference to allow parity across countries for this segment of the industry. Leading industry experts (cross-function) will be leading the discussions and provide their perspectives on challenges and easy wins. You won't find this type of event elsewhere!”
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Topic-Related PDA Technical Reports
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End User complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment by going beyond manufacturer-focused issues and addressing issues specifically encountered within the last mile of the distribution of medicinal products and devices. This revision updates the original 2009 technical report to account for expanded regulations, the development and implementation of newer, more advanced technologies and supply chains that have become more extensive and complex.
Technical Report No. 52: Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
Technical Report No. 54-2: Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling
Technical Report No. 58: Risk Management for Temperature-Controlled Distribution
Technical Report No. 58 provides specific guidance on the identification, assessment, evaluation, control and review of risks in the distribution process, such as receipt, storage, handling and shipping of bulk, intermediate and finished pharmaceuticals, biological medicinal products and medical devices.
Technical Report No. 64: Active Temperature-Controlled Systems: Qualification Guidance
This guidance discusses the process of qualifying actively controlled spaces that are designed to maintain a stable and uniform temperature around the cargo for the duration of transportation or storage at any temperature range.
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
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Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
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Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
Technical Report No. 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
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PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)
Technical Report No. 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
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