Conference Experience
One Conference. Two Ways to Attend.
Join colleagues in-person in Orlando, FL USA and Virtually from anywhere in the world.
In-Person All Access Pass
Attending in-person offers more opportunities for intimate breakouts, roundtable discussions, and networking. Here is what's included:
 | Participate in the Pre-Conference Virtual Networking Event. |
 | Attend the 2024 FOYA Banquet & Awards Celebration |
 | Participate in the 15th Annual ISPE 5K Run/Walk |
 | Attend Keynote, Education, & Post-Conference Training Sessions. |
 | Attend Industry and Regulatory Panels. |
 | Enjoy Breakfast, Coffee, & Lunch in Expo Hall. |
 | Access to ALL Education Content On-Demand for 90 Days. |
 | Dedicated Expo Hall Hours to Discover the Latest Technology & Products. |
 | Mobile App Giveaway Game! Free & Easy to Play with BIG Prizes Available to Win. |
 | Interact with Speakers, Panelists, & Attendees |
 | ISPE Career Center and Headshot Booth |
| Register | |
Virtual Essentials Pass
Network with other attendees and exhibitors, attend the selected live-stream sessions, and identify potential business contacts. Here is what's included:
 | Participate in Pre-Conference Virtual Networking Event. |
 | View selected Live-streamed Keynotes & Education Sessions & Regulatory Panel Discussions. |
| Access to ALL Education Content On-Demand for 90 days. |
| Chat with Exhibitors in the virtual Expo Hall. |
 | Engage with Attendees & Speakers via Chat & Session Q&A. |
| Register | |
Connect, Learn, Grow
However you choose to attend, ISPE provides you with the best means to connect, learn, and grow your career.
Engagement
Connect with colleagues.
Best Practices
Learn from industry experts.
Collaborative
Grow your network through interactive experiences.
Live Streamed Sessions
General Sessions
Coming Soon
Education Sessions
Coming Soon
Featured Networking & Social Events
Saturday, 12 October
2024 ISPE International Emerging Leader Hackathon Day 1 (Additional Registration Required)
2024 ISPE International Emerging Leader Hackathon Day 1
0800 – 1700 | Open to Student & Recent Graduate members | Separate Registration is requiredStudents and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Tuesday afternoon.
Registration coming soon
Sunday, 13 October
2024 ISPE International Emerging Leader Hackathon Day 2 (Additional Registration Required)
2024 ISPE International Emerging Leader Hackathon Day 2
0800 – 1300 | Open to Student & Recent Graduate members | Separate Registration is requiredOn Sunday, each hackathon team will present to the panel of Hackathon judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best-proposed solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Tuesday afternoon.
Registration coming soon
Workshops
1300 - 1600 | Included with In-Person All Access PassWorkshop: Practical Implementation of Digital 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, 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.
Speaker:
Workshop: Technology in Alignment with EU Guidance & eClinical GPG
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.
- 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
- Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
- Data Science and AI-Enabled systems
- Real World Data / Real World Evidence.
Speaker:
Workshop: Robust Quality Management Maturity: APQ and FDA
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.
Speakers:
Workshop: Optimizing Cost of Goods for Cell Therapy Production
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.
Speakers:
Description Coming Soon!
Sunday Social
1600 - 1800 | Included with In-Person All Access PassCheck-in, un-wind and enjoy yourself at the ISPE Sunday Social! Conveniently located on-property, come join us for cocktails, hors d'oeuvres, prizes and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2024 ISPE Annual Meeting & Expo off right!
Facility of the Year Awards Celebratory Reception & Banquet
Facility of the Year Awards Celebratory Reception & Banquet
1900 - 2230 | US$250 | Livestream access ONLY is Included In-Person All Access Pass and the Virtual All-Access PassJoin ISPE to celebrate the 2024 FOYA Banquet and Awards Celebration where we will formally recognize and celebrate the 2024 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner. Please note, the In-Person All Access Pass includes the FOYA Reception and Banquet. All other registration types, MUST register separately and pay. View Details
Monday, 14 October
15th Annual ISPE 5K Run/Walk - Supporting the ISPE Foundation
0600 - 0730 | US$25 | Separate registration and fee are requiredJoin us for ISPE 15th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $50 is required to participate. Registrants must collect their bibs and t-shirts at the Information Desk onsite.
A Networking Soiree, Power and Led by ISPE Women in Pharma
A Networking Soiree, Power and Led by ISPE Women in Pharma, Sponsored by AstraZeneca
1930 - 2130
Join us for an evening of art, history, and culture as Women in Pharma gathers once again in celebration of accelerated equality and inclusivity within our industry. Throughout the two-hour event, you’ll immerse yourself in the ambiance of Italian culture, enjoying cocktails, Italian cuisine, conversations, and appreciating the rich history and cultural significance of the masquerade tradition dating back to the 15th century Venice.Veiled behind your mask, relish the freedom of anonymity, fostering uninhibited exchanges and forging genuine connections. As the night unfolds, masks will be shed, unveiling identities, paving the way for the exchange of business cards, and the cultivation of professional ties, fortified by the shared bond of ISPE’s Women in Pharma.
Please note: All attendees must wear a Venetian-style mask throughout the duration of the event. We highly encourage masks to be elaborate and decorative, covering the eyes and nose area, but should not obstruct vision or impede conversation.
Tuesday, 15 October
ISPE’s Self-Defense Class Powered & Led by Women in Pharma®
ISPE’s Self-Defense Class Powered & Led by Women in Pharma®
0700 - 0800 | Separate registration is requiredM.A.P.S! was founded by a female business owner, mom, ISPE Member, and Black Belt in Martial Arts, Bridget Collins. Her program, M.A.P.S. – stands for Mindset, Awareness, Preparation, Strike! –offers empowering and educational seminars to teach and train women the basics of self-defense, helping them build a mindset and awareness around personal safety that prepares them to avoid personal attacks and defend themselves when necessary. Throughout this early morning session, you will enjoy a demonstration of martial arts techniques, practice of maneuvers to release and defend the most common forms of attacks. This event is open to all conference attendees; we recommend you wear comfortable workout clothes as this will include a workout component for those who participate. A completed waiver will be required to attend the class; this will be available to fill out prior to starting the session.
Tuesday Night Celebration
1900 - 2200 | US$225 | Included with In-Person All Access PassImmerse yourself in an evening of unparalleled networking, delicious food, refreshing drinks, and engaging activities at The House of Blues, where the essence of classic Florida comes alive. Whether you're reconnecting with old friends or forging new professional relationships, this celebration is the perfect opportunity to mingle with industry leaders and colleagues. We've taken care of transportation logistics with round-trip buses provided, ensuring you can focus on enjoying every moment of this vibrant event.
Prepare to experience the best of what the pharmaceutical industry has to offer – this is an evening you won't want to miss!
Wednesday, 16 October
Global Regulatory Town Hall
0950 - 1120 | Included with In-Person All Access Pass and Virtual All Access PassA Regulatory Town Hall Meeting focused on the challenges and opportunities to expand innovation, improve product quality assurance and patient access to medicines relies on global regulatory harmonization and collaborative approaches in establishing effective policies. This paradigm shift is predicated on transformation that only a future-looking workforce can deliver.
The pharmaceutical industry is advancing through an unprecedented innovative transformation, driven by the development of new product modalities, the emergence of innovative technologies, the evolution of alternative and adaptive regulatory frameworks, and the expeditious approaches introduced and leveraged in response to the COVID-19 pandemic experience.
The Regulatory Town Hall will cultivate a compelling discussion among several panelists on the merits, opportunities and challenges associated with the introduction of innovative technologies, the use of modelling, artificial intelligence, and digital platforms that are shaping the future of pharmaceutical development and commercialization. The key messages from this event will provide a template for the attributes and qualities necessary to enlist and engage a skilled and competent workforce capable of adapting to the fluid demands and expectations of patients and health care providers globally.
The panel will include six representatives from industry and regulatory authorities who will address the following evolving topics:
- Mutual reliance: How can the industry and regulators leverage the existing frameworks and initiatives, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Mutual Recognition Agreement (MRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to enhance the mutual recognition and reliance of inspections, assessments, and standards across different jurisdictions?
- Information sharing: How can the industry and regulators enhance the information sharing and communication between and among themselves, as well as with other stakeholders, such as patients, health care professionals, and the public, using the available and emerging digital platforms and tools?
- Modelling: How can the industry and regulators increase the global acceptability and use of modelling and simulation techniques, such as mechanistic models, physiologically based pharmacokinetic (PBPK) models to support the design, development, and evaluation of medicines and vaccines?
- AI algorithms: How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?
- Inspection harmonization: How can the industry and regulators harmonize the implementation and interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (GMP), especially the Annex 1 on the manufacture of sterile medicinal products?
- Supply chain management: How can the industry and regulators improve the resilience, transparency, and security of the global pharmaceutical supply chain, especially in the post-pandemic context, where the demand and supply of medicines and vaccines are subject to unprecedented fluctuations and disruptions?
- Structuring the data: How to address the terminology when submitting data to different regulatory agencies? How to harmonize the data? What kind of standard should be used?
We invite all the participants to share their questions on these topics and engage in a constructive and productive dialogue on charting the direction for innovation in the industry to embrace the future that is now!
Speakers
Annual ISPE Foundation Golf Tournament
Annual ISPE Foundation Golf Tournament
0800 - 1800 | Additional Fees Apply.png)
Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back! The tournament will take place at 12:00pm on 16 October at Celebration Golf Club. Proceeds from the event directly benefit the ISPE Foundation whose mission is “fueling global health equity by fostering access to knowledge and nurturing diverse talent.” Prior to the shotgun start, lunch will be provided and an awards ceremony filled with exciting giveaways will conclude the day. A wide range of exciting sponsorship levels are available to meet your organization's unique preferences and objectives. To learn more about sponsorship opportunities, please contact Dave Dunham (ddunham@ispe.org).
Thursday, 17 October - Friday, 18 October (After Conference)
In Person or Virtual Training (Additional Registration Required)
In Person or Virtual Training
0830 - 1630 | Additional Cost ApplyTake advantage of Deep Dive Pharma Training Courses offered at the 2023 ISPE Annual Meeting & Expo.
- Advancing Pharmaceutical Quality Training Course
- GAMP® Basic Principles Training Course
- Commissioning & Qualification Training Course
- GAMP® Data Integrity 21 CFR Part 11 Training Course
Not able to attend live? No worries, this training event will be live streamed.
ISPE Membership Benefits
Become a member today
Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18,000 pharma professionals from around the world by becoming an ISPE Member.
Benefits include:
- Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
- Member-only discounts on Guidance Documents, Conferences, and Training
- Pharmaceutical Engineering® magazine
- Communities of Practice access to pharma professionals in specific topics from around the world
- And more