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Pharma Labeling Compliance

Optimizing Labeling Strategies to Create Accurate Core Data Sheets and Structured Product Labeling Methods while Meeting Current FDA and International Regulations

20-21 Mar 2013
Hyatt Harborside - Boston, MA, United States of America


Why You Should Attend

Pharma Labeling Compliance

Designing a product label is a long and complex process, from the amount of time that is needed, to creating a label that is compliant with the current FDA regulations.

The marcus evans Pharma Labeling Compliance Conference will explore new ways to overcome these challenges by analyzing the current FDA timelines and regulations that will impact the life cycle of a label as well as will look at one of the hottest topics, Structured Product Labeling (SPL), evaluating how companies are converting their word documents into XML format, and discussing the benefits of Downstream Structured Product Labeling. This conference will then assess the way the product label is designed, how it will meet pharmacovigilance requirements, and be able to track the label’s global compliance.

By attending, delegates will gain a comprehensive view of how to stay compliant with the most up-to-date FDA regulations create an effective labeling strategy, evaluate current Structured Product Labeling (SPL) guidance and track global labeling compliance.

Attending This Conference Will Enable You To:

1. Meet evolving regulatory requirements in labeling compliance to expedite label approval
2.
Create a strategic method for developing a labeling strategy and gathering core content
3. Evaluating the importance of safety and effective translations in labeling

4. Track global labeling compliance to assess the product’s influence in the local regions

Industry leaders attending this conference will benefit from a dynamic presentation format consisting of workshops, panel discussions, and industry-specific case studies that provide accurate, real-world knowledge. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking, and exclusive online access to materials post-event.

What People Are Saying About marcus evans Conferences:

“Great selection and breadth of speakers and uniformly high quality presentations. The intimate nature of meeting provided excellent networking opportunities.” – Abbott Laboratories

“Great in-depth coverage of hot topics in an intimate setting that lent itself to excellent discussions.” – Novartis

“Very well organized meeting. Excellent presentations by experts in the fields.” Asubio Pharmaceuticals


 

 


Key Topics

  • Evaluate labeling compliance to gain a deeper understanding of complying with the current FDA regulations with Pfizer
  • Develop a label and manage it through labeling approval and post-approval maintenance with Vertex
  • Leverage and access Structured Product Labeling (SPL) data through XML process tools with GlaxoSmithKline
  • Implement a global compliance initiative, understanding its evolution, and developing the next stage technology solution with AbbVie
  • Overcome the challenges companies are facing tracking global labeling compliance with Bristol-Myers Squibb
  • Previous Attendees Include

    marcus evans invites Vice Presidents, Heads, Directors, Senior Managers and Managers with responsibilities in:

    - Global Labeling
    - Global Labeling Operations
    - Regulatory Affairs Labeling
    - Labeling and Product Communications
    - Global Regulatory Affairs
    - Labeling Strategy


    Why Choose marcus evans?

    marcus evans specialises in the research and development of strategic events for senior business executives. From our international network of 63 offices, marcus evans produces over 1000 event days a year on strategic issues in corporate finance, telecommunications, technology, health, transportation, capital markets, human resources and business improvement.

    Above all, marcus evans provides clients with business information and knowledge which enables them to sustain a valuable competitive advantage and makes a positive contribution to their success.


    Event Sponsors
    Exhibitor
    Intagras
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    Exhibitor
    Reed Technology
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    Event Partners

    • Regulatory

    • BioCentury

    • BioPortfolio

    • BioSpace

    • Can

    • Cutting

    • Medical

    • Labels

    • Label

    • pharmaphorum

    • PharmaVOICE

    • PharmCast

    • World


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    Event Contact

    For all enquiries regarding speaking, sponsoring and attending this conference contact:

    Robin Yegelwel


    455 N. Cityfront Plaza Dr.
    9th Floor
    Chicago, IL 60611

    Telephone:
    (312) 540-3000 ext. 6483
    Fax: (312) 894-6304
    Email: robiny@marcusevansch.com