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.
This webinar, by expert speaker, Carolyn Troiano, 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.
Who Should Attend
- Casper E. Uldriks
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.