FDA and EMA Global Labeling Challenges Faced in Day-To-Day Operations

Overview

Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as Packet Inserts (PIs), Summaries of Product Characteristics (SmPCs) and Core Data Sheets (CDSs). The large number of product strengths, dosage forms and product presentations results in a large number of labeling records that must be maintained and kept synchronized.

The FDA and EMA are implementing a set of rules for the electronic submission of labeling content. The FDA labelling regulation requires companies to submit XML labeling content in Structured Product Labeling (SPL) format. The EMA labelling regulation 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.

In this webinar, we will discuss ways to overcome these pharma labelling regulatory challenges and understand how companies in the life sciences industries are doing so through best practices.

Why Should You Attend

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.

Areas Covered in this Webinar

• 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 Objectives

• 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 Will Benefit

• Those responsible for Designing, Creating and Maintaining Product Labels and Labeling Records
• Manufacturing and Quality Assurance Professionals responsible for labeling content, format and management
• IT Professionals involved in the conversion of label content formats for electronic labels
• Quality Assurance Personnel
• Auditors engaged in the internal inspection of labeling records and practices
• Consultants working in the life sciences industries responsible for assisting companies with FDA and EMA compliance for labeling content, format and management

Speaker Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Others Details

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