The 2018 ISPE Annual Meeting & Expo agenda will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the globe, offering pharma professionals a unique opportunity to engage in industry-critical conversations.  Expand each day below to see the schedule-at-a-glance and the topics offered in each of the six education tracks.


Track Legend:

  • SC - End-to-End Supply Chain Management
  • FE - Facilities and Equipment Track
  • IS - Information Systems Track
  • IF - Innovation Forum
  • PDPS - Product Development and Production System Track
  • QSR - Quality Systems and Regulatory Track


Track Details


    New Therapies: Impacting and Impacted by Supply Chains

    Supply chain professionals continue to respond to the challenges in making and delivering healthcare products worldwide. The end to end supply chain track will focus on the increasing touch points with patients, differences in new therapies, and examples of improved flexibility and efficiency in supply.

    Key Outcomes:

    • 1. Learn about the changing role of the patient in supply chains – they are now the beginning and end of the supply chain for new therapies
    • 2. Understand industry trends best practices
    • 3. Learn about new innovations in the dynamic environment of supply chains

    Fitness-for-Use/Sustainability/Cost Effectiveness - The Critical Industry Facility Challenges!

    Facilities and Equipment is a very broad track intended to challenge those involved in the delivery of pharmaceutical facilities used to support the development, manufacturing, testing, and storage of pharmaceutical industry products meeting quality standards, employing efficient design and project delivery strategies, and adopting sustainable approaches to meet environmental expectations. Each element of the product lifecycle and the nature of the product provides its unique challenges in designing the facility, selecting the appropriate equipment, and delivering approved pharmaceutical product to improve patient health. The Facilities and Equipment track provides industry owner and industry supplier experts and innovators an opportunity to share best practices and new approaches to benefit the pharmaceutical industry as a whole.

    Key Outcomes:

    • 1. Achieve a better understanding and interact of the challenges presented to owners/users throughout the biopharmaceutical industry world-wide
    • 2. Learn how to confront diverse issues affecting the facilities design, construction and operation, plus adopting, innovations in processing technology, such as single-use manufacturing equipment and techniques, as well as following the regulatory necessities that are very diverse in different parts of the world
    • 3. Experience opportunities to apply proven applications to improve company performance and advance your knowledge
  • Realizing Transformational Technologies in Our Regulated World

    Disruptive changes in Information Systems drive potential for extraordinary benefits in health outcomes and new challenges to the ways the industry assures the integrity of its data and the safety of its consumers. These Information System (IS) sessions will focus on market differentiating innovations including mobile devices, Clinical Systems, and data integrity.

    Key Outcomes:

    • 1. Develop increased understanding of current trends in information systems that impact our industry and regulatory landscape.
    • 2. Gain insight into current approaches to address the challenges associated with key information systems topics including data integrity, cloud computing, clinical systems, and emerging technologies.
    • 3. Benefit from case studies and practical risk-based approaches to real world CSV examples.

    The New Frontiers in Medicine – Innovative Technologies and Applications

    The innovation forum will focus on emerging and evolving technologies that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices as well as novel methods to deliver the next generation of drugs to patients. The intent of this track is to highlight the global Pharmaceutical industry’s challenges, recent innovations, opportunities and success stories relative to the discovery and adoption of emerging technologies for pharmaceutical applications.

    Key Outcomes:

    • 1. Learn about and understand how the most promising emerging technologies are expected to have a profound future impact on the global healthcare industry
    • 2. Explore innovations in small molecule, biopharmaceutical (large molecule) as well as whole cell and tissue engineering
    • 3. Gain insight into regulatory perspectives on the key challenges and opportunities for the adoption of new technologies

    Exploring the Future State of Development and Manufacturing Technology

    The track will explore how new technologies and thinking will change the product development and manufacturing processes and their impact on the future state of the industry through the integration of manufacturing equipment, continuous manufacturing, single-use technology, knowledge management, data analysis and other technologies and methodologies.

    Key Outcomes:

    • 1. Explore and understand new technologies and methodologies and their application
    • 2. Understand impact on product development, manufacture and quality
    • 3. Learn about the flexible manufacturing facility of the future

    Global Trends in Quality, Technical, and Regulatory Harmonization

    This track will focus on regulatory and quality issues related to accelerated access to new medicines and next generation therapies. The challenges and opportunities presented by regulatory convergence for maintenance of product supply and introduction of novel manufacturing techniques.

    Key Outcomes:

    • 1. Understand current trends in regulatory inspections, guidance, and technologies
    • 2. Gain insights into quality & regulatory for novel therapies
    • 3. Hear perspectives from regulators on GMP, CMC and current hot topics

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