April 12th - 22nd, 2021

GCSG 2021 Virtual Boot Camps

Join us for an in-depth look at some of the key clinical supply topics!  Here’s your chance to learn more about Direct-to-Patient (DtP), Import/Export, Essentials of the Clinical Supply Chain, Cell & Gene Therapy (CGT) and Interactive Response Technology (IRT).  More information coming soon!

 

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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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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

Download Now

Essentials of Cell & Gene Therapy Supply Chains

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Exploring Direct to Patient Clinical Trial Models

Download Now

Import / Export for Global Clinical Trials

Download Now

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: Monday, April 12
10:00 am - 12:30 pm
Boot Camp / Seminar

Interactive Response Technology (IRT) in Clinical Supply Chain

Sessions scheduled for April 12th, 13th, 19th and 20th.  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 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.

Speakers
Jan Pieter Kappelle , Terry Panayiotou , Karen Mcnamara
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Day 2: Tuesday, April 13
10:00 am - 12:30 pm
Boot Camp / Seminar

Understanding the Essentials of the Clinical Supply Chain

Sessions scheduled for April 13th, 14th and 15th.  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 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 receive a massive amount of information in a fun and interactive atmosphere.

Speakers
Steven Jacobs , Rob Pizzie
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12:00 pm - 2:10 pm
Boot Camp / Seminar

Essentials of Cell & Gene Therapy Supply Chains

Sessions scheduled for April 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.

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. Supply Chain consideration such as temperature, scalability and regulations for transport will be discussed.

Speakers
Scott Ohanesian , Lindsay Belcher , Paul Ingram , Beth Gardner , Matt Pecora , Matthew Lakelin , Matt Yedwabnick , Sue Lee , Rob Jones
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Day 3: Monday, April 19
10:30 am - 12:00 pm
Boot Camp / Seminar

Exploring Direct to Patient Clinical Trial Models

Sessions scheduled for April 19th, 20th, 21st and 22nd.  All sessions will run from 10:30 AM - 12:00 PM ET except the session on April 22nd which runs 10:00 AM - 12:00 PM ET.  Download the Boot Camp agenda for specifics about what will be covered during each session.

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.

Speakers
Mike Sweeney , Nicole Gray
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11:30 am - 1:30 pm
Boot Camp / Seminar

Import Export for Global Clinical Trials

Sessions scheduled for April 19th, 20th, 21st, 22nd and 23rd.  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.

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. The content is broken into 7 distinct sessions to be offered over the course of 5 days.

Speakers
Ted Bradley , Rich Nelson , Gavin Morgan , Erin Vlack , Camila Drigo , Billie Key
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