This FDA communication best practices webinar will discuss the best practices for communication with FDA staff, general timing of communications, how to deal with deficiencies and key resources for premarket applications and post market communications.
Why Should You Attend:
The US Food and Drug Administration offers a range of mechanisms to communicate with premarket and premarket staff. The timing of communication and best practices to ensure both parties are understand each other’s messages is not well understood. Manufacturers regularly under-estimate the time and preparation required for effective communications for premarket applications and post market communications.
Effective communication with FDA is comprehensive and includes a range of topics including: print, verbal and electronic communication modes. Expert communications requires significant preparation and coordination to ensure both parties have a clear understanding of each other’s planned actions and the related rationale.
Attend this webinar to understand how to get your team prepared and how to plan to communicate with FDA, when to contact and how to contact. What are the risk management techniques to be used to communicate effectively and how to control the narrative for effective result.