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Workshop # Session Title Session Description
Workshop 1 Drug Reconciliation, International Returns  & Destruction Returns and reconciliation have come under greater scrutiny by regulatory authorities in many different countries.  Performing the final reconciliation and disposition of material being returned from a clinical site is typically one of the most challenging aspects of clinical supplies because it requires a better bridge between the GMP and GCP sides of the house.  In this workshop options for completing the return process and ways to reconcile the returns will be discussed.
Workshop 2 Managing Global Expiry Dates What do you need to consider with the implementation of the EU clinical trial regulation in 2018.
Workshop 3 Inspection Readiness / Audit Prep Instilling an inspection ready culture in your operations groups.
Workshop 4 Importer of Record: Tips and Techniques Ever had a shipment going into another country get delayed due to documentation issues? This workshop will provide a discussion of what the Importer of Record does along with various other document requirements that enable shipments between countries to occur smoothly.
Workshop 5 Supplying Pediatric Trials Standard adult clinical supplies are challenging enough, adding a pediatric component to our trials and supply chain increases the complexity exponentially.  This session will share best practices on supplying clinical trial material that is tailored to our youngest patients and support regulatory decision making.
Workshop 6 Sample Requirements for Bioavailability / Bioequivalence  Studies Regulatory requirements for BA/BE studies are complex and are a source of contention between clinical supplies and regulatory affairs.  This session will share best practices on when samples are required and how best to handle them.
Workshop 7 Establishing and Managing a Direct to Patient Supply Chain Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring direct to patient clinical trial models. This workshop is designed to discuss the safety and quality considerations that should be reviewed when planning a robust direct to patient supply chain model.
Workshop 8 Forecasting & Planning on a Budget No money for the modeling tools in your budget?  This session will help you find a solution to your forecasting and planning from your existing spreadsheet program.
Workshop 9 Utilizing Automated Forecasting Tools Sometimes a spreadsheet is just not enough!  This session will cover the latest technology for automated forecasting tools and how to integrate actual consumption to update your forecast. Leave the programming behind and see the system benefits.
Workshop 10 Comparator Track & Trace and e-Pedigree Establishment of good distribution practices (GDP) globally and recent regulatory changes are driving the need to provide traceability of all materials used in a clinical trial.  This session will discuss the options for maintaining identification of comparators used in a trial from purchase to reconciliation.
Workshop 11 Managing Translations for Global Studies Providing printed materials with text properly translated into the local language can be exceptionally challenging.  Language and cultural nuances create difficulties that can cause interruptions in clinical supplies.   This session
Workshop 12 QP Update : How are clinical trial requirements changing in the EU? The quality units and Qualified Persons (QPs) in the EU are adjusting to recent changes in the regulations.  This workshop will provide an update on what those changes are as well as give the opportunity to ask questions and discuss requirements with a QP from the EU.
Workshop 13 Clarifying Roles and Responsibilities Through RACI Chart Knowing everyone’s role & responsibilities is an essential requirement for successful teams.  This workshop will provide an overview and process methods for deploying a RACI (Responsible, Accountable, Consulted, Informed)  chart in support of those outcomes.
Workshop 14 Interactive Response Technology Configuration & Validation This session will provide guidelines for converting your trial design into a successful IRT configuration.  Validation, user acceptance criteria and testing will be explored.
Workshop 15 BioSimilars and BioBetters: More than Generic Biologicals This workshop will discuss the biosimilar/ biobetter development process, how they differ from innovator products and the challenges with development and clinical trials.
Workshop 16 Supply Chain Requirements for Cell & Gene Therapy The distribution and handling of precious gene therapy supplies requires a higher level of controls to ensure quality and sustainability.
Workshop 17 Regulatory Labeling and Customs Requirements for CTM in Latin American Countries Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of Latin American countries for labeling and distribution as well as how they impact CT supplies timelines and planning.
Workshop 18 Regulatory Labeling and Customs Requirements for CTM in Asia Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of Asian countries for labeling and distribution as well as how they impact CT supplies timelines and planning.
Workshop 19 Strategies for the Handling of Ancillary Supplies Ancillary supplies could be considered the items no one wants to take responsibility for due to their unique procurement and distribution challenges. Over the years they have fallen squarely on the shoulders of clinical supplies folks. This workshop will be a discussion of the various practices used for procuring, stocking, and distributing ancillary items to clinical sites.
Workshop 20 Impact of Automated Commercial Environment (ACE) on US Imports Don’t have an Import Export team of experts for your clinical supply chain?  Come to this session to learn about the impact of the Automated Commercial Environment (ACE) on US Imports and what clinical supply chain can do to help build the information needed to clear your supplies.
Workshop 21 Global Trends in Clinical Supply Logistics Awareness of the regulatory requirements across different agencies is critical for being a successful CT Supplies professional.  This workshop will contain a discussion comparing the regulatory requirements of countries as well as how they impact CT supplies timelines and planning.
Workshop 22 Just In Time Clinical Supply Come to see a demonstration and have discussions about utilizing Just in Time throughout your Clinical Supply Chain.  Learn how to mitigate risk and gain quality endorsement!
Workshop 23 Writing Robust Quality and Technical Agreements Writing robust quality and technical agreements with vendors & partners can be challenging.  How much detail to include?  What are the key items? Where to start?  Come to this session to have engaging discussions on the best practices when writing these key documents.
Workshop 24 BREXIT Update -Impact to Clinical Supplies What does the UK exiting the EU mean to our Clinical Trial Supply Chain?  Come to this session to discuss ways to work through this change.
Workshop 25 Deviation Handling – Getting to Root Cause In our highly regulated industry, one area that always needs focus seems to be investigation and deviation writing.  The only way to really reduce recurrence is to find true root cause and develop good preventative actions.  Come practice your skills and talk about how to really get to root cause.
Workshop 26 Let’s Talk Medical Devices This workshop will discuss the ins and outs of medical devices from classification to blinding and everywhere in between.  Come share your expertise or come find a mentor to help you through the complexity of medical devices.
Workshop 27 On Demand Labeling This session will discuss the options you have in using on demand labeling at the point of distribution to reduce timelines and increase supply flexibility.
Workshop 28 Project Management Everyone in Clinical Supply Chain uses some sort of project management in their daily jobs.  Come to this session to discuss some project management best practices or share some of yours!  Whether you are new to Clinical Supplies or a seasoned professional, there is something for everyone in this workshop!
Workshop 29 Building a Quality Culture As the world of clinical supplies becomes increasingly complex it is essential that clinical supply partners with Quality to achieve the best outcomes.  An essential step in this process is to build a quality culture within the clinical supply unit.  This session will discuss ways to build that culture within your own organization.
Workshop 30 The Benefit of Integrated Supply Chain Systems With the mergers and acquisitions standard within our industry, we sometimes find ourselves trying to integrate multiple clinical supply chain systems to create a functional platform within the new organization.  This session will discuss how to influence the decision making process and strategies for integration as well as bundled systems that solve these issues.
Workshop 31 Country Specific Import/Export Requirements Country Import/Export regulations are constantly changing. In order to expedite shipping of clinical supplies, this workshop will provide updates to specific geographic areas that will decrease delays and issues for CTM logistics.
Workshop 32 BRRRR… It’s Cold in Here!  Options for Packaging & Shipping Frozen Products This informative session will discuss the risks and mitigations to consider when packaging, labeling & shipping all levels of frozen product – from the mildly frozen to deep freeze products.   Come with your questions and your knowledge to make the most of this interactive session.

Manna Signature

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