FDA and EMA Global Labeling Challenges and Requirements

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

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have implemented a set of rules for electronic submission of labeling content. As per FDA, the companies are required to submit XML labeling content in Structured Product Labeling (SPL) format. Whereas, the EMA requires companies to submit product information documents in a format that is QRD-compliant.

Companies, which are in the regulated life sciences industries, should develop and implement systems and processes to ensure compliance with these standards for their global labeling content. Those companies should also take a longer-term view about minimizing the complexity and cost of doing so.

Why You Should Attend:

This webinar will discuss the ways to overcome these regulatory challenges and understand how companies in the life sciences industries are doing so through best practices.

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

Areas Covered in the Session :

  • Product labeling background and rationale
  • 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
Who Should Attend:

  • 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.
  • All pharmaceutical, biotechnology, medical device and tobacco companies that are regulated by the FDA or an international equivalent agency.

FDB2449

Carolyn Troiano

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.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
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