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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 Industry rates only. Offer ends at 2359 EDT on Friday, 20 September 2024
Featured Sessions
FDA Oversight of Drug Quality - Compliance
Oct 14, 2024 | 1630 - 1700
Presenter: FDA
Explore how the reconfigured quality assessment offices and research divisions are creating a more streamlined, agile, and flexible organization, reinforcing connections between assessment, inspection, surveillance, research, and policy operations. Delve into the reorganization of the Office of Regulatory Affairs into the Office of Inspectional and Investigations, aimed at reducing duplication and streamlining actions for greater clarity and promptness in enforcement.
Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures.
ISPE Regulatory
Town Hall
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines.
All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.
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Workshops
Sun, 13 Oct
1300 – 1600
Workshops
Hubertus Rehbaum, PhD, 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. OUTLINE
13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 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. OUTLINE
13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 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
David Raab, Genesis AEC
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.
Ken Rando
Head of Business Development for North America
COMECER
COMECER
David Raab
Senior Process Engineer
Genesis AEC
Genesis AEC
Evan Lamb
Product Specialist
SKAN US, Inc
SKAN US, Inc
Erich Bozenhardt
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
United Therapeutics
Jeffery Odum
Practice Leader: ATMPs & Biologics
Genesis AEC
Genesis AEC
1300 – 1600
Workshops
Guido Kremer-van Der Kamp, Merck Chemicals GmbH
Jill Hammond, FDA
Yolanda McLean, Alnylam Pharmaceuticals
CDR June Page, FDA
Tonya Wilbon, FDA
Vivien Santillan, Novatek International
Women in Pharma Proudly Presents the Adaptable Leadership Workshop
Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.
Ideal for professionals in leadership roles, compliance officers, and those seeking to enhance their influence within a team, this workshop will delve into essential areas such as trust-building, emotional intelligence, and fostering team confidence. The session will feature engaging icebreaker activities and will culminate in an insightful panel discussion with FDA representatives and other compliance experts.
Workshop Agenda:
Adaptable Leadership
Explore strategies for developing leadership skills that can flexibly adapt to changing environments and challenges.
We are all Humans – Regulatory Interaction
Gain insights into effective audit practices, focusing on behaviors that foster cooperation and ensure compliance.
Team Building and Emotional Intelligence
Engage in activities designed to enhance trust, communication, and emotional intelligence within your team.
Fostering Team Confidence
Learn techniques to inspire and build confidence among your team members, empowering them to excel in their roles.
Panel Discussion with the FDA and Other Compliance Professionals
Participate in an interactive discussion with leading experts, including representatives from the FDA, on best practices and emerging trends in compliance, moderated by Yolanda McLean.
Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.
Ideal for professionals in leadership roles, compliance officers, and those seeking to enhance their influence within a team, this workshop will delve into essential areas such as trust-building, emotional intelligence, and fostering team confidence. The session will feature engaging icebreaker activities and will culminate in an insightful panel discussion with FDA representatives and other compliance experts.
Workshop Agenda:
Adaptable Leadership
Explore strategies for developing leadership skills that can flexibly adapt to changing environments and challenges.
We are all Humans – Regulatory Interaction
Gain insights into effective audit practices, focusing on behaviors that foster cooperation and ensure compliance.
Team Building and Emotional Intelligence
Engage in activities designed to enhance trust, communication, and emotional intelligence within your team.
Fostering Team Confidence
Learn techniques to inspire and build confidence among your team members, empowering them to excel in their roles.
Panel Discussion with the FDA and Other Compliance Professionals
Participate in an interactive discussion with leading experts, including representatives from the FDA, on best practices and emerging trends in compliance, moderated by Yolanda McLean.
Guido Kremer-van Der Kamp
Senior Consultant, Global BioPharm Center of Excellence
Merck Chemicals GmbH
Merck Chemicals GmbH
Jill Hammond
Director of Training and Regulatory Science
FDA
FDA
Yolanda McLean
Senior Director, Quality Control
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
CDR June Page
Senior Regulatory Officer
FDA
FDA
Tonya Wilbon
Assistant Director for DICE and Branch Chief for CDRH
FDA
FDA
Vivien Santillan
Regional Director, Asia
Novatek International
Novatek International
Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry
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.