Practice the ISPE Good Practice Guide Series – Expert Workshops at the 2024 ISPE Annual Meeting & Expo

1. “Practical Implementation of Digital Transformation” based on the ISPE Baseline Guide Volume 8: Pharma 4.0TM First Edition principles
2. “Technology in Alignment with EU Guidance and eClinical GPG” – eClinical best practices based on the application of the ISPE GAMPR Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice)
3. ”Robust Quality Management Maturity: Advancing Pharmaceutical Quality (APQ) and Leading Research” based on the ISPE APQ GPG Series methodologies
4. “Optimizing Cost of Goods for Cell Therapy Production” based on the ISPE Guide: ATMPs – Autologous Cell Therapy
5. “Adaptable Leadership: Navigating Agility, Styles, and Communication Preferences” – powered and led by ISPE’s Women in PharmaR on navigating agility in a volatile, uncertain, complex, and ambiguous (VUCA) world

The practical GPG-based workshops will provide students, emerging leaders, and seasoned industry professionals with the opportunity to engage in thought-provoking conversations to explore innovative solutions to the challenges our industry faces today. The use and reference of the ISPE GPGs will allow the workshop participants to reflect and to subsequently work on a deeper studying and understanding of the related topics. The workshops will be facilitated by well-renowned industry leaders who will make attendance starting Sunday worthwhile.

“Practical Implementation of Digital Transformation”

Digital transformation is not a technology transformation only. It’s a digital business transformation: organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, the worker experience, product quality, and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information, and knowledge—including their people’s implicit and tacit knowledge—to maintain a competitive advantage and meet these high demands. This workshop is setting up a new methodology to educate participants as to how to apply the ISPE GPGs in a holistic way across all disciplines to leverage digitalization benefits across the whole organization.

The first workshop on this topic took place at the 2024 ISPE European Annual Conference. Attendee feedback and learnings from the presenters have been incorporated into this updated session, which is expected to yield faster learnings.

“Technology in Alignment with EU Guidance and eClinical GPG”

In light of the requirements discussed within the European Medicines Agency’s “Guideline on Computerized Systems and Electronic Data in Clinical Trials” and the information provided within the new ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice), the workshop will explore challenges with implementing new technologies used in support of clinical trials.

1. Decentralized clinical trials: This workshop will cover risks and concerns associated with the use of eClinical platforms, e.g., ePRO, eCOA, interactive response technology (IRT)/randomization and trail supply management (RTSM); It will also cover roles and responsibilities for systems and validation, challenges in the distribution of an investigational medicinal product (IMP), and bring your own device (BYOD) approaches.
2. Good clinical laboratory practice: The workshop will help attendees to consider any risks and concerns associated with the use of partners; data transfer; systems and validation.
3. The data science and AI-enabled systems will speed up the complex processes. This workshop will reflect this along with real world data and real world evidence.

“Robust Quality Management Maturity: APQ and Leading Research”

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies. This ISPE Advancing Pharmaceutical Quality Program and GPG Series is intended to provide a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization. The APQ Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act & Advance Framework. APQ includes practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can be evaluated and then improved upon.

“Optimizing Cost of Goods for Cell Therapy Production”

This session will present two case study vignettes where companies used the ISPE Baseline Guide concepts to form the basis of design for a new manufacturing asset. The case studies focus on key ISPE Guide principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization. Specific references to the Guide will be provided as part of the interaction with the audience.

“Adaptable Leadership”

Enhance your leadership style as this session explores how understanding individual and team communications preferences can enhance collaboration and job satisfaction. In this workshop, powered and led by ISPE’S Women in Pharma, we will explore leadership agility, team dynamics and the diverse tapestry of communication styles that weave a fabric of connectivity in the workplace. This dynamic session is designed to propel you into action, providing a platform for self-reflection on your leadership approach, an exploration of professional "love languages," and insights into effective self-motivation and team empowerment.

The 2024 ISPE Annual Meeting & Expo is shaping up to be an event pharmaceutical professionals cannot afford to miss. With a record number of workshops being offered on Sunday, conference attendees will have the opportunity to attend highly engaging and thought-provoking three-hour sessions to start off their 2024 ISPE Annual Meeting & Expo experience. The program committee hopes to see you in Orlando, Florida on Sunday, 13 October, for this year’s workshops.

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