Update on Just-In-Time (JIT) Labeling
- Identify at least two (2) countries that will accept Just-in-Time (JIT) labeling of Investigational Products.
- Explain the process for JIT labeling and at least one (1) circumstance under which it may be a preferred strategy.
- Compile a list of quality requirements for JIT labeling.
Controlled Ambient: Challenges in Storage and Distribution
- Describe three (3) key changes in Investigational product distribution triggered by recent Good Distribution Practices guidelines.
- Compare and contrast the economics of shipment under controlled ambient conditions versus uncontrolled conditions.
- Describe at least two (2) methods of achieving controlled ambient conditions during shipment.
Why Are So Many “Teams” Not Really Teams?
- Be able to name at least seven attributes of true teams
- Describe the three major phases of the Tuckman Team Lifecycle Model
- Be able to do a preliminary assessment of teams for strengths and weaknesses
Labeling at Clinical Sites: Yes or No?
- Identify at least one circumstance where labeling at a clinical site might be appropriate.
- Compile a list of quality and regulatory requirements for labeling at a clinical site.
- Compare and contrast the economics of site labeling vs. alternatives.
A New Paradigm?
Implementing Direct-to-Patient Shipments
- Identify at least three (3) countries that have accepted direct-to-patient distribution of Investigational Products.
- Identify at least three (3) challenges associated with direct-to-patient distribution.
- Compare and contrast the direct-to-patient distribution process with traditional distribution of clinical supplies.
Qualified Person (QP) Update
- Summarize the current changes in QP requirements in the EU.
- Describe how QPs standardize requirements and processes.
- Compare and contrast QP release vs. QA release.
Maximize Your Performance with Enhanced Presentation Skills
- List no less than two (2) ways to open a presentation that builds energy and adult learning.
- Explain at least three (3) ways to ensure presentations will not be boring, unfocused, or overly long and drawn out.
- Differentiate the different techniques of bad presentations versus good, exciting, customer focused presentations.
Techniques and Challenges in Blinding Biologic Products
- Describe at least three (3) challenges specific to blinding of biologic products.
- Give three (3) different techniques used to effectively blind biologic products.
- Define why blinding of biologics is important.
“Good to the Last Vial”: Pooling Investigational Product Supplies
- Explain at least two (2) different levels of pooling of supplies.
- Identify at least three (3) factors that contribute to the success of a pooling strategy.
- Describe at least one (1) real-life case study where pooling of investigational product was done successfully.
Biosimliars and Biobetters: Next Generation Therapeutics
- Define biosimilars and biobetters.
- Identify at least two (2) challenges to development of biosimilars/biobetters.
- List at least two (2) challenges to clinical supplies for studies supporting biosimilar/biobetter development.
Sites and CRAs: The Other Side of Clinical Supplies Distribution
- List at least three (3) important characteristics that identify a site as a potential candidate for participating in a clinical study.
- List at least three (3) special areas of expertise / knowledge expected of Clinical Research Associates (CRAs).
- List at least two (2) characteristics of the sponsor and protocol which attract site to participate in studies.
API and Simple Dosage Forms: Strategies to Accelerate First-in-Man Trials
- Describe at least three (3) strategies to conduct First-in-Man testing prior to developing a tablet dosage form.
- Describe at least three (3) strategies for packaging Investigational Material for a First-in-Man trial.
- Compare and contrast the supportive analytical studies for a First-in-Man dosage form and a compressed tablet.
Building a Comparator Consortium: The Transcelerate Experience
- List at least one (1) criteria for company membership in the transcelerate comparator consortium.
- Break down the benefits and challenges of being part of the transcelerate comparator consortium.
- Identify one (1) other value, besides comparator sharing, to being part of the Transcelerate consortium.
Considerations for Site-to-Site Transfer of Investigational Drug Product
- Identify at least two (2) circumstances under which site-to-site transfers of Investigational Product might be acceptable.
- Compile a list of quality requirements for site-to-site distribution of Investigational Product.
- Compare and contrast the economics of site-to-site transfers versus alternatives.
Ins and Outs of Investigator Initiated Studies
- Define Investigator Initiated Studies.
- Identify at least two (2) circumstances which would not require an IND for a US-sponsored Investigator Initiated Study.
- List at least three (3) ways a sponsor can support an Investigator Initiated Study.
Specifics in Handling Controlled Substance Accountability and Returns
- Compare and contrast the controlled substance accountability and return process in the US vs. the rest of the world.
- List at least two (2) unique aspects of returns and accountability for US C-II controlled substances.
- List at least three (3) challenges in handling controlled substance returns globally.