Best Practices for Communicating Nitrosamine Strategies Between Makers and Users

Learning/Awareness Objectives
Attendees were provided with:
> Background and overview of regulatory expectations relative to excipients, including a review of regulatory changes in the past 12 months
    – Need for drug product manufacturers to complete testing for nitrosamines in their drug products based on risk assessment outcomes  
> Discussion of additional support that may be requested from excipient suppliers, based on confirmatory test results
    – Potential supplier response to user needs (based on IP, capabilities, competitive intelligence, etc.)
> Options for excipient users to use information obtained from their excipient supplier in the identification of products at risk of N-nitrosamine formation or contamination 
    – Tips for effective communications between excipient suppliers and users 
    – Feedback from users on what has worked well vs what has been a challenge
> Proposed best practices and strategies for ongoing communication between excipient suppliers and users
    – information required for new excipients
    – information needed when current excipient information changes 
 
Who should attend?
> Excipient manufacturers, users, distributors 
> Regulatory affairs
> Compendial affairs
> Quality affairs