In 2017, the FDA introduced new guidance for naming biosimilars and biologics, and the EMA made changes to their name review schedule that will impact submission deadlines and planning. This year, the industry began to understand the impact Health Canada’s 2015 naming guidance is having on drug name approvals.
Drug Name Development: The Regulatory Changes to Know About & How to Prepare for a Successful 2018
But how do these changes affect your trade name development and regulatory name submission strategies?
During this webinar you will learn about securing drug name approvals from three major regulatory bodies:
- FDA
- Overview of the 2017 guidance for non-proprietary naming of biological products
- Prospective Naming vs. Retrospective Naming of Biologicals
- Helps ensure your tradename will pass guidance
- EMA
- Recent changes to the EMA NRG review schedule and how this impacts your asset’s timeline
- Recommendations for successful name submissions with the EMA NRG
- Health Canada
- Two years have passed since Health Canada released the agency’s updated naming guidance
- Hear what we have learned and our recommendations moving forward
- Looking forward to 2018 and best practices to set up your name submissions for success
