Recorded April 22, 2021
In 2016, Health Canada announced its intention to adopt a structured format for its drug product information. With this structured format, Health Canada aims to increase transparency and accessibility of pertinent data. The move would affect product monograph preparation, electronic submission and approval processes for human prescription drugs. As we enter 2021, these Health Canada mandates and timelines become more important than ever.
Join the experts at Reed Tech for a webinar detailing what you need to know including timeline and mandates. The webinar will further discuss XML PM data elements, template changes, preparation, submissions and what’s involved with eCTD.
The submissions to Health Canada will have many similarities and many differences from FDA submissions. It will be important to note that XML PM preparation for Health Canada is unique considering there will be no option to prepare directly through Health Canada and companies will be required to build or buy an XML PM application.
Gary Saner, Sr. Manager of Information Solutions and Katelyn (Zumpino) Clark, Account Executive at Reed Tech Life Sciences will discuss:
• What is required
• What you need to do to prepare
• Updates to Health Canada's timeline & important milestones