Education Sessions by Track

Please use the track listing to help locate which sessions may be of interest to you. Education sessions fall into multiple tracks so you may see them listed more than once.

Many of the education tracks correspond to a Certified Pharmaceutical Industry Professional™ (CPIP™) Knowledge Element. CPIP is a competency-based international credential.

arrow  Important Information About ISPE's Education Programs

arrow  More Information About CPIP

Survival

The theme of this year’s ISPE Annual Meeting is Thriving in a Survival Environment. ISPE education sessions are created by ISPE Members who work every day in the same environment that you work and face similar challenges. As Volunteers, ISPE Member presenters bring their good ideas to the Annual Meeting table sharing knowledge, insight and application through these education sessions, aiming to strengthen the pharma environment through this medium. This track has a lot to offer! Sessions include:

Product Development (CPIP Knowledge Element 1)

CPIP knowledge element one includes: formulation, clinical phases, and manufacture; technology transfer; production scale-up and optimization. Sessions in this track feature content in these areas. Sessions include:

Facilities and Equipment (CPIP Knowledge Element 2)

CPIP knowledge element two includes: design and construction/installation; commissioning and qualification as a risk management strategy; operation and maintenance; controls and automation. Sessions include:

Information Systems (CPIP Knowledge Element 3)

Sessions include:

Supply Chain Management (CPIP Knowledge Element 4)

CPIP knowledge element four includes: materials management; operational economics; warehouse and distribution management. Sessions include:

Production Systems (CPIP Knowledge Element 5)

CPIP knowledge element five includes: production unit operations - drug (small molecule) and biologics; production management; production control. Sessions include:

Regulatory Compliance (CPIP Knowledge Element 6)

CPIP knowledge element six includes: government regulations; standards, practices, and guides. Sessions include:

Quality Systems (CPIP Knowledge Element 7)

CPIP knowledge element seven includes: risk management and Quality Management System (QMS); systems validation. Sessions include:

Investigational Products

The Investigational Products (IP) Community of Practice (COP) brings together industry professionals for interactive learning and networking opportunities. This year’s sessions include educational topics that address challenges that industry professionals face in their day-to-day lives, as well as emerging or strategic topics important for managers and decision-makers. For all programming in this track, simply register for session 700. This track’s sessions take place from Monday afternoon through Wednesday morning. Most registrants sign up for the full track, but also may wish to select sessions on Sunday afternoon and Wednesday afternoon. Please see the overall schedule for session options at those times.

700 - Innovation in a Regulated Environment includes:

  • Adaptive Clinical Trials
  • Optimizing the Client Vendor Relationship
  • Considerations for Managing and Motivating Clinical Supplies Personnel
  • Concepts for Managing Clinical Supply Inventory
  • Extemporaneous Preparation of Clinical Trial Material (CTM) at the Investigational Site
  • Supply Options for Investigator Sponsored Studies
  • Panel: Key Success Factors and Strategies for Outsourcing
  • Utilization of Simulation for Supply Forecasting (Case Studies)
  • Clinical Supplies in Japan
  • Options for Supplying Non-Investigational Medicinal Products
  • Evolution and Future Application of Simulation
  • Import/Export
  • Cold Chain
  • Innovative Packaging and Labeling Approaches
  • Wild Card session with industry thought leaders and specialists, where attendees will have the opportunity to ask questions and gain perspectives

Project Management

The PM Community of Practice (COP) has chosen two distinct, large-scale capital projects to feature through six highly-interactive sessions for the Project Management Track. Attend the first of these sessions for an in-depth presentation of each project and then explore each of the following using the case studies as the basis for discussion and insight.

Supplier-Focused

Suppliers are an incredibly important part of this program and offer a superb knowledge resource. This year, sessions of particular interest to suppliers are listed as a track to recognize this important facet of ISPE educational programming. Sessions include:

Annual Meeting Sponsors