Preliminary Workshops

Workshop Title

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.

Manna Signature