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2016 EU Workshops

WorkshopLearning objectives
Cultural Challenges

Facilitator: Sue Lee (World Courier) The attendee will be able to
- Identify two ways to recognize when cultural differences could lead to issues
- Describe three common factors that lead to communication problems across cultures
- Summarize the three key ways you can be more proactive in understanding culture and adapting when working with people from other cultures
Who should be importer of record?

Facilitator: Alex Klim (DHL)
- Give one example of a distribution challenge where Importer of Record was a necessary part of the documentation
- Compare and contrast successful and unsuccessful methodologies for documenting importation.
- Identify at least one person that can sign on the importer of record document
Emotional Intelligence: Difficult conversations

Facilitator: Steve Jacobs (Global BioPharm Solutions, LLC)
- Identify no less than four key tenants of Emotional Intelligence
- Compare and contrast the value of a high Emotional Quotient (EQ) versus a high Intelligence Quotient (IQ)
- Define the key skill and the key tool necessary to successfully have difficult conversations
Fast Track Phase 1 studies: Shortening timelines to 1 month

Facilitator: Ignacio Gomez-Arroyo Bernabeu (J&J)
- Determine no less than two ways to shorten Phase 1 studies through increased efficiencies in clinical supplies management
- Explain the reason why shortening Phase 1 trials has become such a high priority in drug development
- Differentiate between standard Phase 1 clinical trial requirements and Fast Track Phase I clinical trial requirements
eLabels: Advantages and controls related to eLabel process

Facilitator: Jodi Smith-Gick (Eli Lilly),

Co-facilitator: Roger Lauwers (J&J)
Summarize how e-labels work and how they can eliminate expiry date update requirements
- Compare and contrast how e-labels will be used on IMPs versus standard booklet labels
- List two out of three technical requirements required if you transition to e-labeling
Innovation in ensuring patient compliance

Facilitator: Helen Underwood (Fisher Clinical Services)
- List no less than two reasons why patients are not always compliant in taking their IMPs
- Summarize how dosing schedule, size, taste, and amount of dosages to be taken at a given time will impact patient compliance
- Present no less than two new concepts that will increase patient compliance with IMPs
Approval process for temperature controlled shipments

Facilitator: Neta Bendelac (Teva)
- Explain the importance of having an approval process for temperature controlled IMP shipments
- Give examples of what can go wrong during temperature controlled distribution of IMPs
- Summarize how the Good Distribution Practices (GDPs) have had an impact on temprature controlled shipments of IMPs
Influencing without authority

Facilitator: Nick Fewings (Ngagementworks Ltd)
- Identify the challenges of getting people to execute tasks without a direct line of authority
- List no less than two ways leaders can motivate team members to accomplish goals in a matrixes organization
- Give examples of how an IMP manager can influence stakeholders in order to get the best outcomes for everyone
Investigator Initiated Trials: Challenges in Supporting

Facilitator: Mark Ware (Clinigen Clinical Trial Services)
- Identify at least two regulatory hurdles that must be overcome when conducting global IITs
- List two things that a clinical supplies project manager must keep track of and control when conducting IITs
- Compare and contrast the clinical supplies requirements between standard clinical trials and IITs
Cost Transparency in Clinical Supplies World

Facilitator: Jan Pieter Kappelle (UCB)
- Identify no fewer than two key aspects of financial tracking and control for IMPs
- Explain the benefits of understanding IMP planning and forecasting Return on Investment (ROI)
- Give examples of where high levels of waste exist in the IMP supply chain and how to reduce them

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