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.
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.
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.
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.