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

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

January 17, 2023 from 8:00am to 1:00pm EST

Registration is open now until January 11, 2023.

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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.

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Speakers / Panelists

Sponsors

Platinum Sponsor

Michele Kay
Registration is now closed

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