1) Forecasting and Planning to Eliminate Waste
Tentative Facilitators:
Chedia Abdekafi, N-Side; Buz Hillman, Centacor; Nick Lenares, Tourtellotte Solutions
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Provide an overview of a business case for procuring forecasting and planning tools (e.g., to support initial supply and resupply, maintain demand over time)
- Describe the benefits that result from using forecasting and planning tools (e.g., money or time savings, accuracy of information)
- Give examples of real-life situations where a forecasting tool was used
2) Labeling Challenges in Unique Package Types (CE credits)
Tentative Facilitators:
Keith Hobson, Celgene; Patrick Newingham, MedImmune; Mike Donahue, Clintrak
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- List minimum labeling requirements for small packages in the U.S. and EU.
- Identify the clinical supply container types that provide the greatest challenges for labeling
- Explain at least two concepts used to solve these challenges
3) Global Label Requirements (CE credits)
Tentative Facilitators:
Veronica Onumah, Merck; Donna McDermott, Merck; Chris Ellis, Aptuit
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Differentiate among U.S., EU and rest of world (Asia, Africa, Latin America) labeling requirements
- Break down what must go on the label for material to be distributed globally
- Discuss label design as a component of effective planning for global studies
- List two situations where poor labeling delayed study start
4) Mentoring and Leadership Development in Clinical Supplies Organizations
Tentative Facilitators:
Kathleen Roesing, KMD Consulting; Ida Vogelzang, Merck; Mike Sather, VA Cooperative Studies Program
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Give examples of both effective and ineffective leadership approaches within clinical supply organizations
- Develop a mentoring program to support leadership and team development, as well as "on the job" leadership training
- Identify leadership tools for building and maintaining high performing teams in constantly changing clinical supply organizations
5) Clinical Supply Management of Investigator Initiated Studies (IIS) (CE credits)
Tentative Facilitators:
Donald Parriott, Daichi-Sankyo; Peggy Sue Fernandes, AstraZeneca
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Discuss the challenges of packaging and labeling clinical supplies to support Investigator Initiated studies
- Summarize IIS distribution challenges and key "lessons learned" and provide illustrative examples
- Explain at least two rate-limiting legal aspects when working with clinical trial supplies for IIS
6) Temperature Controlled Container Qualifications
Tentative Facilitators:
Kevin Grimm, Merck; Paul Harber, Eli Lilly; Vince Paolizzi, Nanocool
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Identify at least two reasons why cold chain containers should be qualified for clinical supply distribution
- Provide at least two key aspects of clinical supply temperature controlled container qualification
- List at least three components that go into a qualified cold chain clinical supplies shipping container
7) International Controlled Substance Challenges (CE credits)
Tentative Facilitators:
Anne Zanolli, Bilcare; Seth Levy, Shire; Patrick Bolger, University of Rochester
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Give at least two examples of what can go wrong when controlled substances are not handled correctly in clinical supply distribution
- List at least three challenges to be overcome when distributing controlled substance to global clinical sites
- Compare and contrast the differences between global controlled substance classifications
8) Import and Export of Clinical Trial Materials into Emerging Markets; central Europe, Middle East, Africa (CEMEA) (CE credits)
Tentative Facilitators:
Scott Jacoby, World Courier; Sharon Courtney, Almac; Mark Woolf, Almac
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Summarize the challenges of shipping clinical trial supplies into emerging markets (specifically into central Europe, Africa or the Middle East)
- List at least two solutions designed to streamline the ability to import clinical supplies into emerging market countries
- Describe at least two examples of clinical supply shipments into an emerging market country, one of which went smoothly and one where the opposite was true. Develop "lessons learned" around those examples.
9) Annex 13 Update from Competent Authority Perspective (CE credits)
Tentative Facilitator:
Florence Doumergue, QP, CRID Pharma (France)
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Identify at least two key, recent changes to Annex 13 clinical supplies regulatory requirements in the European Union (EU)
- Explain the impact of changes to Annex 13 on clinical supplies entry into, and release within, the EU
- Compare and contrast the differences between Qualified Persons (QPs) from France and England in the EU
10) Dealing with Global Cultural Challenges for Clinical Supplies Project Managers
Tentative Facilitators:
Sivakumar (Kumar) Rajagopalan, PriceWaterhouse Coopers, Steven Jacobs, Global BioPharm Solutions
Workshop Learning Objectives:
At the completion of this workshop, attendees will be able to:
- Describe at least three key tenets to follow in order to successfully overcome cultural issues on global clinical supplies teams
- Provide at least two cultural differences that project managers should always consider when driving outcomes for global clinical supplies teams
- Identify at least three examples of cultural issues that have arisen on global clinical supplies teams and how to overcome them
