The GCSG 2018 European Knowledge Forum: Program

The attendee will be able to:

1. Describe at least three (3) historical events that drove the development of GMPs


2. Identify at least three (3) Quality rules to ensure IMP production meets global regulatory standards


3. List three (3) regulatory requirements when shipping temperature controlled IMPs

The attendees will be able to:

1. Identify four (4) roles necessary for completing an international shipment and the responsibilities of each of the roles


2. Identify at least three (3) documents needed to be maintained for recordkeeping and explain why they must be kept


3. Name the global association that has responsibility for writing customs valuations guidance

The attendee will be able to:

1. Describe no fewer than two (2) ways clinical supplies shipments can go out of spec (OOS) and two (2) ways to decrease the risk of this happening


2. Summarize all of the systems used in the clinical supply chain to ensure temperatre controls are in place from warehouse/depot to clinical/patient site


3. Identify the differences between maintaining Controlled Room Temperature (CRT) shipments and refrigerated (2-8ºC) or frozen (-20ºC) shipments

The attendee will be able to:

1. Describe two (2) benefits each for the clinical site, sponsor and patient of a direct to patient trial


2. Identify at least two (2) risks for sponsors and develop an effective mitigation strategy for these risks


3. Identify two (2) late stage customization strategies that can support delivery of medication closer to the patient thus minimizing waste

The attendee will be able to:

1. List the two (2) biggest fears the industry has regarding the impact of Brexit on the clinical supply chain in Europe


2. Theorize about what countries will pick up the slack of the UK clinical supply chain after Brexit is implemented


3. Give examples of how the clinical supplies industry has already been impacted by Brexit

The attendee will be able to:

1. Define the differences between Cell and Gene Therapy (CGT) products and small molecule products


2. Identify the challenges of shipping CGT compared to standard shipments


3. List no fewer than three (3) ways to overcome those shipping challenges

The attendee will be able to:

1. Summarize the differences between how a small company clinical supply manager needs to think versus a large company clinical supply manager


2. List no fewer than two (2) challenges that a small company clinical supply chain manager has ever day


3. List no fewer than two (2) advantages that a small company clinical supply chain manager has

The attendee will be able to:

1. List no fewer than two (2) reasons why virtual teams lose motivation & engagement


2. Describe ways to increase and enhance communication to keep virtual teams productive


3. Compare and contrast virtual team leadership vs co-located team leadership

The attendee will be able to:

1. Describe the differences between clinical supply chain planning for common diseases versus rare diseases


2. List no fewer than two (2) challenges that impact the clinical supply chains for rare diseases


3. Summarize how rare disease clinical trials impact the clinical supply chain and provide one solution for handling rare disease cliical supply chains

The attendee will be able to:

1. Describe three (3) situations where knowledge of regulatory requirements can positively influence clinical supply chain outcomes


2. Summarize how differences in emerging market regualtory requirements can effect shipping and distribution channels


3. Present the best way you can be aware of, and access, changing merging market regulations for clinical supplies used in global clinical trials

The attendee will be able to:

1. Explain what patient centricity is and its value in clinical studies


2. List the areas of the clinical supply chain that need to be better oriented toward patient centricity


3. Compare and contrast how Patient Centricity was built into clinical supplies packaging and labeling five (5) years ago versus where it needs to be in (5) years

The attendee will be able to:

1. Describe no fewer than two (2) ways airports and airlines maintain control of clinical supplies


2. Summarize the end to end supply chain controls at airports that ensure clinical supplies are secure and temperature controlled


3. Identify no fewer than three (3) ways clinical supply chain planners can contribute to the supply chain and temperature controls of clinical trial materials when they arrive at the airprort

The attendee will be able to:

1. Compare the differences between how we currently value the clinical supplies Pharmacist versus how we should value them, along with the patient


2. Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial


3. Summarize the negative clinical trial Pharmacist experiences with clinical supplies and identify no fewer than two (2) ways to address them