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.
Register for this webinar to learn more and have your questions answered by the subject matter experts at Reed Tech on Thursday, April 22nd at 2PM ET.
Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech
Gary Saner 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.Message Presenter
Katelyn (Zumpino) Clark, Account Executive, Reed Tech
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.Message Presenter
Who Should Attend?
- Regulatory Affairs and Operation Leaders
- Operations and Supply Chain Leaders
- Global Strategy Business Managers
- Compliance Officers
- Regulatory Affairs/Operation Leaders
- Product Managers
- Business Analysts
What You Will Learn
In this webinar, participants will learn about:
- XML PM Product Monograph Overview/Comparison to FDA
- XML PM Data Elements
- XML PM Timeline and History
- XML PM Preparation and Submission Requirements and Options
Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis company.
Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.