October 13 - November 16, 2020

GCSG 2020 Virtual Boot Camps

You asked for more in-depth coverage of many of our workshop topics at the recent Global Virtual Conference.  Here’s your chance to join us for in-depth discussions on six timely topics!  Our boot camps are open to anyone wanting to learn more about one or more of these key subjects – Expanded Access, Import/Export, IRT, Cell & Gene Therapy, Direct to Patient and the Essential of the Clinical Supply Chain.  Come join the discussion!

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Resources
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Understanding the Essentials of the Clinical Supply Chain

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Essentials of Cell & Gene Therapy Supply Chains

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Expanded Access Platforms

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Exploring Direct to Patient Clinical Trial Models

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Import Export for Global Clinical Trials

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Interactive Response Technology (IRT) in Clinical Supply Chain

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Resources
View the Boot Camp Schedules

Understanding the Essentials of the Clinical Supply Chain

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Essentials of Cell & Gene Therapy Supply Chains

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Expanded Access Platforms

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Exploring Direct to Patient Clinical Trial Models

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Import Export for Global Clinical Trials

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Interactive Response Technology (IRT) in Clinical Supply Chain

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NOTE: Each boot camp consists of multiple sessions. Download the individual schedules to the left
Day 1: Tuesday, October 13
12:00 pm - 2:10 pm
Boot Camp / Seminar

Essentials of Cell & Gene Therapy Supply Chains

Sessions scheduled for October 13th, 14th and 20th.  All sessions will run from 12:00 PM - 2:10 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp is expected to qualify for up to 5.25 hours of pharmacy or nursing continuing education (CE) credits.


  • Cell & Gene therapies are increasing at an impressive rate. It is important to understand the manufacturing processes and supply chain requirements of these life-saving therapies. This boot camp will describe and contrast the different manufacturing and supply chain requirements of autologous and allogeneic cell and gene therapies.

Topic
Biologics
Day 2: Thursday, October 15
2:00 pm - 4:00 pm
Boot Camp / Seminar

Expanded Access Platforms

Sessions scheduled for October 15th, 19th, 22nd and 26th.  All sessions will run from 2 PM - 4 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp does NOT qualify for pharmacy or nursing continuing education (CE) credits.


  • This interactive seminar will give an overview of expanded access and discuss new regulations and their impact on the planning and execution of Expanded Access Programs.


 

Topic
Regulatory
Day 3: Tuesday, October 20
10:00 am - 12:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

Sessions scheduled for October 20th, 21st and 22nd.  All sessions will run from 10:00 AM - 12:30 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp is expected to qualify for up to 6.75 hours of pharmacy or nursing continuing education (CE) credits.


  • This class is geared toward people new to the clinical trial supplies world, and focuses on drug development and what goes into planning for and delivering a study drug for a clinical trial. Topics include: reasons behind Good Manufacturing Practices (cGMPs), phases of new drug development and approval, randomizing and blinding clinical trial materials, quality assurance and documentation, protocol interpretation, patient compliance, labeling, standard operating procedures, stability, Good Distribution Practices (GDPs), returned drug accountability, and changing regulations in the EU and ROW. Attendees will hear a massive amount of information in a fun and interactive atmosphere.

Topic
Supply Chain
Day 4: Monday, October 26
10:30 am - 11:30 am
Boot Camp / Seminar

Exploring Direct to Patient Clinical Trial Models

Sessions scheduled for October 26th, 27th and 29th and November 2nd, 3rd and 5th.  All sessions will run from 10:30 AM - 11:30 AM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp is expected to qualify for up to 4.5 hours of pharmacy or nursing continuing education (CE) credits.


  • Expanding access to patient populations, faster recruitment, increasing patient retention and decreasing time to market are all reasons sponsors are exploring Direct-to-Patient (DtP) clinical trial models. This bootcamp is designed to discuss best practices to engage your clinical teams, clinical sites, and couriers to ensure a successful partnership in a DtP supply chain model.

Topic
Direct to Patient
11:30 am - 1:30 pm
Boot Camp / Seminar

Importing and Exporting Clinical Supplies

Sessions scheduled for October 26th and November 2nd, 9th and 16th.  All sessions will run from 11:30 AM - 1:30 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp is expected to qualify for up to 7 hours of pharmacy or nursing continuing education (CE) credits.


  • The class is designed for clinical supplies professional that want to learn more about shipping and distribution for global clinical trials. This seminar will cover regulations, temperature control, customs challenges, and logistics supply chain partnerships to ensure success with international distribution.

Topic
Import/Export
Day 5: Tuesday, October 27
11:30 am - 1:30 pm
Boot Camp / Seminar

Interactive Response Technology (IRT) in Clinical Supply Chain

Sessions scheduled for October 27th and 29th and November 9th and 11th.  All sessions will run from 11:30 AM - 1:30 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.  This boot camp is expected to qualify for up to 7 hours of pharmacy and nursing continuing education (CE) credit.


  • This class is geared towards people that have some experience in the clinical trial supplies world. Attendees will be provided with a quick overview and then will take a deeper dive into Interactive Response Technology (IRT). This will include the development path for IRTs; the stages of build, from creating the User Requirement Specification (URS) to quoting, coding, validation, user acceptance testing and go-live; the reasons to use an IRT as well as when NOT to use an IRT; build requirements, including randomization codes and med code IDs; ensuring modules are built to manage individual regulatory country approvals, shipping requests and returns and reconciliation; as well as timelines from concept development to system go-live.

Topic
IRT

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