Call for Proposals

The 2018 ISPE Annual Meeting & Expo will focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the globe. This signature event draws pharmaceutical and biopharmaceutical professionals at all levels of the industry from young professionals to the most senior executives in drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies.

Timeline:

  • Opens: 15 December 2017
  • Deadline: 28 February 2018
  • Committee Review: 28 February – 1 April 2018
  • Notifications: 2 April 2018

By submitting a proposal, you acknowledge that, if your proposal is accepted, your organization will support your attendance at the conference(s). Accepted Annual Meeting Leaders and Speakers are responsible for their own travel and accommodations and receive complimentary registration for the day on which their session is scheduled. Interested Leaders and Speakers may purchase full conference registration at the following discounted rates:

Before
24 Aug
24 Aug -
25 Sept
After
25 Sept
$1,365 $1,495 $1,625

Submit Proposal

Track Topics:

End-to-End Supply Chain Management

New Therapies: Impacting and Impacted by Supply Chains

Communities of Practice: Operations Management – Investigational Products – Packaging – Serialization SIG

  • Capacity planning – Synchronizing the supply chain
  • Continuous Manufacturing – Integration with traditional batch processes
  • Biologics Growth – Adaptability in supply chain for new processes, products, and technologies
  • Lean improvements in pharma – demand pull
  • Technology – Applications of technology in the supply chain and operations research
  • Packaging – Cold chain, temp monitoring, and innovative packaging techniques
  • Supply chain industry model changes – How patients affect supply chains
  • Business continuity models for acquisitions and mergers
  • Process excellence - Lean training and organizational culture
  • Serialization – Understanding the complexities and roll-out of serialization
  • Package inspection – Physical and visual Inspection for final fill-finish quality

Facilities and Equipment

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

Communities of Practice: Commissioning and Qualification – Containment – Critical Utilities – HVAC/Sustainable Facilities – Project Management

  • Innovative approaches to facility function and design. (i.e., modular design, continuous manufacturing operations, flexibility, and disposables)
  • Integrating ASTM principles into the project delivery process; optimizing the Regulatory approval process
  • Latest trends in sustainability (i.e., water, waste, energy, and equipment reliability). Industry best practices and savings that have been achieved.
  • Latest trends in F&E maintenance. Moving past PM and PM shutdown periods
  • Challenges in designing and delivering same product/process facilities in multiple countries
  • Repurposing legacy facilities for new products
  • Applying QRM to critical utilities - How applying QRM to design and qualification of CUs can simply the design process and expedite the qualification and validation
  • Moving “out of the box”, shifting from traditional manufacturing strategies to innovative means

Information Systems

Realizing Transformational Technologies in Our Regulated World

Communities of Practice: GAMP and Data Integrity SIG

  • Practical Experiences in Data Integrity
  • Clinical/R&D systems
  • Devices in Biotech and Therapeutic Applications
  • Digital Health
  • Cloud Validation
  • IT Security and Regulatory Compliance
  • Diversity and Inclusion in the IS Sector

Innovation Forum

New Frontiers in Medicine – Innovative Technologies and Applications

  • The genomic revolution: Cell and gene therapy, including cell engineering, such as CAR-T cells, and advances in gene editing technologies
    • Emerging technologies in cell and gene therapy for the development and manufacturing of drug product
    • How are manufacturing facilities evolving to enable cost-effective regulatory compliant production of these new modalities
    • How is the field of quality assurance and sciences adapting to personalized medicine?
  • Advances in the field of 3D printing
    • Recent advances in 3D printing of biomaterials including implants, diagnostic platforms, scaffolds for tissue engineering and biomedical devices. Personalized regenerative medicine is of high interest
    • Drug delivery applications
    • Utility in large scale pharmaceutical manufacturing facilities
  • Digital innovation in an evolving manufacturing paradigm
    • Applications of multivariate data analysis in the context of continuous manufacturing
    • Applications of machine learning
    • Advancements in predictive process and plant modeling tools…..data acquisition, storage and analysis

Product Development & Production Systems

Exploring the Future State of Development and Manufacturing Technology

Communities of Practice: Biotechnology – Disposables – Oral Solid Dosage – PAT and Lifecycle Control Strategy – Sterile Products Processing

  • Pharma 4.0 and the production control strategy
  • Continuous processing
  • Operational excellence
  • Flexible manufacturing
  • Knowledge management and data analysis, including data integrity

Quality Systems & Regulatory

Global Trends in Quality, Technical, and Regulatory Harmonization

Communities of Practice: PQLI - Process Validation - Process Capability - Quality Metrics - Commissioning and Qualification - Sterile Products Processing - Biotechnology

  • Impact of Natural Disasters on Drug Supply/Shortages
  • Inspection Challenges with Novel and Breakthrough Therapies
  • Global Regulatory Harmonization
  • Regulatory Aspects of Analytical Methods Development
  • Clinical Relevance - Impurities vs. Dissolution vs. Biologics
  • Drug Device Combinations
  • Facility and Utility Impact on Quality
  • Accelerated Development Programs
  • GMP, CMC Aspects of Continuous Improvement
  • Process Validation
  • Globalization of Emerging Technologies
    • Continuous Manufacturing
    • Real-Time Release Testing
    • Quality & Regulatory Challenges
  • Quality and Regulatory Implications for Continuous Manufacturing
  • Technology Transfer

Submit Proposal