Understanding ICH Q12 Regulatory and Technical Considerations to Manage Post Approval Changes

Date and Time

17th

January

8:00AM-1:00PM

EST

Program Overview

Click here for the brochure.

The CAPRA Symposium Committee will host a half-day virtual interactive session to provide an update on the implementation of ICH Q12 in Canada and the changes made to the Post-NOC changes guidance document to support the implementation.

Attendees will learn the objectives and the scope of the ICH Q12 guidelines and the impact and benefits of its implementation. This symposium will also share recent pilot program experiences on Established Conditions (ECs) and Post Approval Change Management Protocols (PACMPs) from both Health Canada and Industry.

This symposium will provide attendees with an opportunity to raise questions and concerns about this topic.

This event will be of interest to:

·        Regulatory Affairs professionals for pharmaceuticals and biologics;
·        Pharmaceutical Scientists and Quality Assurance personnel;
·        Research and Development Scientists;
·        Manufacturing & Technical Services Subject Matter Experts.

How to Access the Event

To access this program, please ensure you have completed payment and registration here. Once this is done, you will receive a confirmation email and link/password to access the event.