Day 1 : Tuesday, October 17
Bootcamp Registration Open
Pre-Conference Workshop - Clinical Supplies Foundations Boot Camp
This class is geared toward people new to the clinical trial supplies world. Attendees will be provided with an overview of drug development and what goes into planning for and delivering the study drug for a clinical trial.
Included in the training will be the reason behind:
- cGMPs
- Phases of new drug development and approval
- Randomizing and blinding clinical trial materials
- Quality Assurance & documentation
- Protocol interpretation
- Patient CTM compliance
- Labeling
- SOPs
- Stability
- Good Distribution Practices
- Returned drug accountability
- Changing regulations in the EU and ROW
This is an informal workshop that will give attendees a massive amount of information in a fun and interactive atmosphere.
Speakers:
Conference Registration Open
Exhibitor Set Up
Presenters / WS Facilitators Orientation
New Member Orientation
Speakers:
Meet & Greet: GCSG Networking Event
Day 2 : Wednesday, October 18
Breakfast - Registration Open - Exhibitor Displays Open
Welcome & Opening Remarks
Speakers:
Rainer Hersch, Keynote Presentation: “Peak Performance – what can business learn from a symphony orchestra”
In his inspirational talk he presents structured module titled “Peak Performance – what can business learn from a symphony orchestra”. He uses his skills as a comedian, a PowerPoint presentation and plenty of musical examples to completely engage the audience in his discussion of leadership from the standpoint of the orchestral conductor.
Speakers:
Room transfer- tea/coffee break
BREXIT Update - Impact to Clinical Supplies
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials
Speakers:
Defining patient experience (site nurse)
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them
Speakers:
Leadership vs management
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage
Speakers:
Retaining talent
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)
Speakers:
Vendor / sponsor relationship excellence
1.) List no fewer than three (3) competencies required to establish an optimal supplier/sponsor relationship
2.) Compare and contrast the differences between successful and unsuccessful supplier/sponsor relationships
3.) Explain no fewer than two (2) practices that keep sponsor companies from forming a good vendor/partner relationship and describe no fewer than two (2) ways to overcome those challenges
Speakers:
Room transfer
BREXIT Update - Impact to Clinical Supplies
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials
Speakers:
Globalization of clinical trials and impact on supply chain
1.) Identify new and emerging countries and list no fewer than two (2) ways the clinical supply chain can be interrupted in these countries
2.) List no fewer than two (2) ways the supply chain process can be improved to support globalization
3.) Explain no fewer than two (2) ways to enhance regulatory knowledge to expedite clinical supply chain globalization
Speakers:
Optimizing CTM Supply Chain Design
1.) Identify challenges faced by using the current “Push” Clinical Supply Chain model
2.) Describe why changes must be made to evolve to a “Pull” supply chain model with the impending launch of the Clinical Trial Regulation (CTR)
3.) Give no fewer than two (2) examples of optimization methods and how to implement those methods
Speakers:
Practical aspects of shipping Cell Gene Therapy
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
Speakers:
Retaining talent
The attendee will be able to:
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)
Speakers:
Lunch - Exhibitor Displays Open
Defining patient experience (site nurse)
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them
Speakers:
Future of IRT
1.) Explain the advantages and limitations of the current IRT model
2.) List no fewer than three (3) key changes anticipated that will improve current IRT systems
3.) Explain ways in which companies can prepare for these changes and leverage those updates
Speakers:
Innovation of the clinical supply chain: e-meds
1.) Summarize how the e-meds concept can transform the traditional clinical supply chain requirements
2.) Identify no fewer than two (2) key components of this innovative supply chain solution that may enhance patient compliance
3.) Explain the regulatory challenges of implementing this new clinical supply chain technology
Speakers:
Leadership vs management
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage
Speakers:
Vendor / sponsor relationship excellence
1.) List no fewer than three (3) competencies required to establish an optimal supplier/sponsor relationship
2.) Compare and contrast the differences between successful and unsuccessful supplier/sponsor relationships
3.) Explain no fewer than two (2) practices that keep sponsor companies from forming a good vendor/partner relationship and describe no fewer than two (2) ways to overcome those challenges
Speakers:
Room transfer - tea/coffee break
Patient Testimonial
Speakers:
Membership and Benefits
Speakers:
Vendor Reception & Vendor Competitions
Closing Remarks, Survey Completion and Prize Draws
Buses depart for evening entertainment
Please wear your badges
Evening Entertainment
Day 3 : Thursday, October 19
Breakfast - Registration Open - Exhibitor Displays Open
Opening Remarks / Committee Recognition
Patient Centricity – Keeping the patient front and center in clinical and commercial development
1.) Compare and contrast how this innovative concept is different from the traditional clinical supply chain
2. ) List the advantages and the disadvantage of this new concept and identify two (2) ways to overcome the disadvantages
3.) Explain no fewer than two (2) ways this concept could positively impact the clinical supply chain in the future
Speakers:
Room transfer - tea/coffee break
Defining patient experience (site nurse)
1.) Compare and contrast the differences in clinical supplies requirements of the site versus the patient
2.) Explain the importance of providing clear and concise instructions for taking clinical supplies during the trial
3.) Summarize the negative patient experiences with clinical supplies and identify no fewer than two (2) ways to address them
Speakers:
Optimizing CTM Supply Chain Design
1.) Identify challenges faced by using the current “Push” Clinical Supply Chain model
2.) Describe why changes must be made to evolve to a “Pull” supply chain model with the impending launch of the Clinical Trial Regulation (CTR)
3.) Give no fewer than two (2) examples of optimization methods and how to implement those methods
Speakers:
Practical aspects of shipping Cell Gene Therapy
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
Speakers:
Retaining talent
The attendee will be able to:
1.) Summarize the importance of retaining clinical supplies (CS) employees and the impact of losing them
2.) Explain why retention is more important than recruitment
3.) Identify ways to motivate CS employees to increase retention within the Clinical Supplies Unit (CSU)
Speakers:
Vendor / sponsor relationship excellence
1.) List no fewer than three (3) competencies required to establish an optimal supplier/sponsor relationship
2.) Compare and contrast the differences between successful and unsuccessful supplier/sponsor relationships
3.) Explain no fewer than two (2) practices that keep sponsor companies from forming a good vendor/partner relationship and describe no fewer than two (2) ways to overcome those challenges
Speakers:
Room transfer
BREXIT Update - Impact to Clinical Supplies
1.) Define BREXIT
2.) Identify next steps in the BREXIT process
3.) Identify two (2) key aspects of how BREXIT will impact Clinial Trials
Speakers:
Future of IRT
1.) Explain the advantages and limitations of the current IRT model
2.) List no fewer than three (3) key changes anticipated that will improve current IRT systems
3.) Explain ways in which companies can prepare for these changes and leverage those updates
Speakers:
Globalization of clinical trials and impact on supply chain
1.) Identify new and emerging countries and list no fewer than two (2) ways the clinical supply chain can be interrupted in these countries
2.) List no fewer than two (2) ways the supply chain process can be improved to support globalization
3.) Explain no fewer than two (2) ways to enhance regulatory knowledge to expedite clinical supply chain globalization
Speakers:
Innovation of the clinical supply chain: e-meds
1.) Summarize how the e-meds concept can transform the traditional clinical supply chain requirements
2.) Identify no fewer than two (2) key components of this innovative supply chain solution that may enhance patient compliance
3.) Explain the regulatory challenges of implementing this new clinical supply chain technology
Speakers:
Leadership vs management
1.) Discuss the key differences between a manager and a leader
2.) List no fewer than three (3) repercussions of acting only as a manager or only as a leader
3.) Give no fewer than three (3) situational examples of when it’s best to lead or to manage
Speakers:
Lunch - Exhibitor Displays Open
Presentation- Non-pharma Supply Chain
1.) Compare and contrast the supply chains and identify two (2) ways the clinical supply chain might learn from the non-pharma supply chain
2.) Differentiate the supply chain critical path items and how they can be overcome on the clinical supply chain
3.) List at least two (2) ways the non-pharma supply chain was able to overcome key country challenges in order to expedite customer delivery
Speakers:
Closing Remarks, Survey Completion and Prize Draws
Speakers:
