Target audience

Learning outcomes

1. Explain regulations and challenges related to maintaining identical safety content between generic and branded labels 
2. Compare/contrast the effort required to achieve consistency between a Company Core Data Sheet, a reference-listed drug (RLD) label and generic drug label based on industry studies 
3. Plan an approach to assess content differences in your company’s generic labels globally

This course will cover

• The regulations for generic labels require that the generic label be identical to the branded, or reference-listed drug (RLD) label.
• The positions of leading Health Authorities will be described relative to the safety sections of the drug label, e.g. warnings and precautions, contraindications, and adverse events.
• Attendees will be informed on current regulations and how they impact the branded and generics industry.
• An overview will explain the current requirements and responsibilities of health authorities along with the generics and branded manufacturers.
• Attendees will see the challenges that generics companies and health authorities face as they try to maintain compliance across the labels. despite these regulations, a significant percentage of generic labels differ from the branded label on important safety information.
• The results of a study will be shared that assessed the similarity and differences of labelling content available to the general consumer.
• Sources of public labelling content will be provided, this will illustrate the range of discrepancies for hundreds of product labels across multiple government and industry websites.
• The process of label harmonization between the Company Core Data Sheet, the RLD, and the generics label will be illustrated. These processes will be compared and contrasted, as it differs depending on which type of label is being assessed.
• Results from a second study will provide real-time examples of the types of critical safety information which is inconsistent between the generic and branded labels. These are categorized into critical and major gaps related to death, hospitalization, or serious adverse events.
• Attendees will learn how to initiate their own generic label alignment program, its importance, KPIs, and best practices to make it successful to ensure that key safety information is identical between the generic and RLD labels. Note: drug names and manufacturers will not be disclosed In the study results.

Mauricha Marcussen, CEO, Auditgraph
Mauricha is Chief Executive Officer of Auditgraph, she has worked with over 25 top pharmaceutical companies in leadership roles and as an FDA inspector and industry consultant. 
In her current position, she leads global regulatory affairs programs and creates sustainable technology solutions for global product labelling harmonisation, regulatory information management, and international e-submission requirements. #

CPD
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Cost of the course

Members: £90.00

Non members: £114.00

All prices are in pounds sterling and include VAT