Webinar:

Best Practices for Comparator Sourcing and Labeling Strategies

Sponsored by: Fisher Clinical Services

Focused on:

  • Labelling

Date: 13 November

Days to go: 28

Time: 3PM London/10AM New York

How streamlining labeling processes can help drive a successful comparator sourcing strategy

Sourcing comparator, rescue medication, or co-medication for clinical trials is not merely a purchasing or procurement exercise. It’s important to have a strategic approach, evaluating every sourcing factor and creating a customized plan with multiple options to ensure an optimal sourcing strategy.

Similarly, clinical trial labeling requires an equally high level of oversight and management especially when it comes to labeling of comparator drug product. There are many factors to keep in mind in order to protect the integrity of the blind, as well as meet stringent regulatory controls. In an effort to meet timeline and cost expectations of clinical trials, labeling processes for comparator products can be streamlined. Strategies may include maintaining a library of comparator products for quick reference label placement; managing translations of drug inserts and labeling of comparator for locally sourced drug.

Topics covered on this webinar include:
• Supply Chain Management
• Comparator Sourcing
• The benefits of early engagement
• Strategies and considerations for labeling of comparator drug product
• Top tips on defining successful comparator sourcing and labeling strategies
• Case Study Examples of Success

Presented by

Montie Bowie,

Director, Global Business Development at Thermo Fisher Scientific

Montie, Global Director of Comparator Sales for Fisher Clinical Services, leads an international team that helps clients procure commercial drug for the biological and pharmaceutical industry. Montie believes the drug development industry is one of the most dynamic markets in the world and every step in the process has the ability to transform a life. Prior to his current role, Montie worked 5 years as a Business Development Executive for Patheon, where he took great pride in helping clients further their compounds along the drug development continuum. Before Patheon, Montie worked with a leading CRO in sales, marketing and operational leadership.
In 2002 Montie completed his MBA at Cardinal Stritch University. Montie holds a BSBA from Columbia College in Columbia, Missouri (1994).

Kevin Shea,

Senior Label Program Director

Kevin currently serves as the Senior Label Program Director — Clintrak Clinical Labeling (Bohemia) and has been with Fisher Clinical Services since May 2006. His experience in clinical labels and label translation services spans many years previously holding positions like production coding, label design and project management. With a Bachelor’s Degree in English from Hobart College, Kevin likes to balance his work with quality family time and his relatively new pastime, golf.

Key Learning Objectives

  • Learn how supply chain management refines your comparator sourcing strategy
  • Understand the benefits of early engagement
  • What you need to consider for labeling of comparator drug product and proven strategies that work
  • Learn about your industry peer successes in real case examples

Audience

  • Vice President Comparator Sourcing Supply Chain/ Clinical Logistics
  • Senior Director/Executive Director
  • Clinical Operations Director/Manager Clinical Development Directors/Managers
  • Clinical/Investigational Suppliers
  • Clinical Logistics & Supplies Director/Manager
  • Clinical Trials Director/Manager
  • Supply Chain
  • Logistics & Distribution Director/Manager
  • Quality (Management/Assurance/Control/GCP/GMP)
  • Director/Manager
  • Clinical Supply Team
  • Comparator Sourcing Team
  • Clinical Management
  • Procurement Team
  • Clinical Trial Team
  • Supply Chain Department (CRO)
  • Clinical Development
  • Investigator sites
  • Clinical Operations
  • Clinical Supplies & Investigational Supplies
  • Clinical packaging
  • Clinical Labeling
  • Clinical Quality Assurance/Quality Control
  • Regulatory affairs
  • Clinical Project Management