FDA and EMA Global Labelling Challenges and Requirements

Product Id : FDA15
Instructor : Carolyn Troiano
May 03, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Basic Concepts, Challenges and Methods:

The FDA and EMA are implementing a set of rules for the electronic submission of labeling content.  The FDA requires companies to submit XML labeling content in Structured Product Labeling (SPL) format.  The EMA requires companies to submit product information documents in QRD-compliant format.

Companies in the regulated life sciences industries must develop and implement systems and processes that will ensure compliance with these standards for their global labeling content.  They must also take a longer-term view as to how best to minimize the complexity and cost of doing so.

  • Understanding the New FDA and EU Labeling Requirements
  • Understand Best Practices for Meeting the Challenges of New FDA and EU Labeling Requirements
  • Understand How to Effectively Manage Cost vs. Compliance for Meeting the New FDA and EU Labeling Requirements

In this webinar, we will discuss ways to overcome the regulatory challenges based on the new requirements from FDA and EMA regulations.  You will understand how companies in the life sciences industries are doing so through best practices, and in a way that reduces cost while maximizing compliance.

Core Points:

  • Product labeling background and rationale
  • Requirements for complying with FDA and EMA requirements for labeling
  • Converting Word documents into XML and SPL format
  • The essential labeling materials that are covered
  • Organizing and maintaining labeling records efficiently and effectively
  • Inspection of labeling records

Learning Benefits:

You should attend this webinar if you are responsible for designing, creating or implementing product labels, or maintaining labeling records. You should also attend if you are responsible for developing and maintaining the systems required for submitting XML labeling content in Structured Product Labeling (SPL) format. Finally, you should attend if you are responsible for ensuring compliance with labeling requirements for your company.

Key Topics:

  • Learn what product labeling material is subject to FDA and EMA regulation
  • Understand the specifics of FDA and EMA regulations for product labeling and how to comply
  • Learn how to establish and maintain a well-organized system for product labeling, and provide quality assurance for the data included
  • Learn the importance of developing a consistent system for locating labeling records, and preparing them for regulatory inspection
  • Learn about best practices and industry standards

Who Should Attend:

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Quality Managers, Chemists and Microbiologists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Pharmaceutical and Medical device manufacturers
Speaker Profile:

Carolyn Troiano has vast experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries, in which she has worked as a consultant for over 30 years. She has provided services to many large pharmaceutical and tobacco companies throughout the US and Europe. As part of her services, she has helped develop and execute compliance strategies and programs.

Carolyn also has experience in supply chain security and compliance, which includes technologies and procedures for improving the protection of companies’ brand integrity. At present, she is active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI).


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