Understanding ICH Q12 Regulatory and Technical Considerations to Manage Post Approval Changes
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
The two options for payment are as follows:
- Credit card payment online
- Third-party payment via credit card
Please note: Under the new incorporated CAPRA, credits for meetings can no longer be issued. In order to attend a meeting, payment must be received prior to the meeting registration deadline. Registrants for whom payment has not been received will be refused entry to the meeting.
Add the registration option to your cart. After completing the checkout process, you will be provided with a link to the Event Registration form(s) where you can provide us with the details of the attendee(s). If you have registered for previous events, then you can simply confirm your previously submitted details, or make changes where needed.
Registration is now closed