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Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
*Restrictions apply. Offer applies to In-Person All Access Pass and In-Person Essential Pass member/non-member rates only. Offer ends at 2359 EDT on Friday, 23 August 2024.
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Workshops
Sun, 13 Oct
1300 – 1600
Workshops
Hubertus Rehbaum, Dr. Rehbaum Technology Consulting GmbH
Mark O'Connor, AstraZeneca
Andrew Palm, Pfizer
Paige Kane, MSD
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, 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 a continuation of the European Annual Meeting Workshop and will include learnings and output from attendees. As well, comparisons from US and European attendees’ experiences will be made to benefit future ISPE content.
1300 – 1600
Workshops
Geetanjali Abbi, Alkermes
Lorrie Vuolo-Schuessler, Retired
Brandi Stockton, The Triality Group, LLC
Petch Ashida Druar, Syneos Health
In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence.
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence.
1300 – 1600
Workshops
Thomas Friedli, University of St.Gallen
Tami Frederick, Perrigo
Nuala Calnan, Biopharm Excel Ltd
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 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 Advancing Pharmaceutical Quality (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.
1300 – 1600
Workshops
Ken Rando, COMECER
Evan Lamb, SKAN US, Inc
Erich Bozenhardt, United Therapeutics
Jeffery Odum, Genesis AEC
Optimizing Cost of Goods for Cell Therapy Production--Current and Future Tools for Consideration This session will present two case study vignettes where companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset. The case studies focus on key 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.
1300 – 1600
Workshops
Guido Kremer-van Der Kamp, Merck Chemicals GmbH
Jill Hammond, FDA
CDR June Page, FDA
Tonya Wilbon, FDA
Adaptable Leadership: Navigating Agility, Styles, and Communication Preferences
Enhance your leadership style as we explore how understanding individual and team communication 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, exploring professional "love languages," and insights into effective self-motivation and team empowerment.
Who should attend?
Students poised at the threshold of their careers can seize an early grasp of these pivotal concepts, recognizing the pivotal role of effective communication and collaborative prowess in the realm of leadership.
Enhance your leadership style as we explore how understanding individual and team communication 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, exploring professional "love languages," and insights into effective self-motivation and team empowerment.
Who should attend?
- Senior Leaders stand to refine their leadership ethos and embrace novel strategies to nurture a thriving workplace ambiance.
- Mid-level executives can unlock invaluable insights, enhance team synergy and communication, and hone their unique leadership persona, priming themselves for the next career milestone.
- Emerging Leaders on the brink of their journey can craft the foundational pillars of their leadership identity, mastering the art of adaptation and interpersonal communication amidst the diverse tapestry of the workforce.
Students poised at the threshold of their careers can seize an early grasp of these pivotal concepts, recognizing the pivotal role of effective communication and collaborative prowess in the realm of leadership.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.