How to Navigate Health Canada XML PM Requirements
Sponsored by: Reed Tech
- Xml Pm
- Drug Product Information
Date: 27 January
Time: 11AM EST/4PM London
Learn from experts at Reed Tech how upcoming mandates will affect you
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.
To learn more and have your questions answered by the Subject Matter Experts at Reed Tech, join us for a webinar on Wednesday, January 27th at 11AM EST / 4PM London. You can register here. We look forward to speaking with you then!
Senior Manager, Information Solutions
Gary Saner (Sr. Manager Information Solutions, Reed Tech) is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.
Katelyn (Zumpino) Clark,
Katelyn (Zumpino) Clark helps Life Sciences companies save time and effort while complying with FDA and Health Canada drug registration requirements. In addition, Katelyn helps organizations streamline drug label research and comparisons for product development and competitive comparisons. Reed Tech serves customers with the expertise required in the Life Sciences industry. The services and software tools we provide as part of our Pharmaceutical Services have assisted over 1,000 pharma companies in complying with complex FDA Electronic Drug Listing/Labeling and Registration requirements.
Key Learning Objectives
- XML PM Template changes
- XML PM Data elements
- XML PM preparation and submissions
- Regulatory Affairs and Operation Leaders
- Operations and Supply Chain Leaders
- Global Strategy Business Managers
- Compliance Officers
- Regulatory Affairs/Operation Leaders
- Product Managers and Business Analysts