Once regulatory approval has been achieved the pharmaceutical medicine requires maintenance throughout the product lifecycle. In this instance CMC plays a role in communicating regulatory risks and mitigation's and provides cohesive risk-based regulatory submissions that can achieve timely regulatory authority approvals.
This webinar will cover...
- An introduction to managing changes globally
- Managing compliance
- Challenges associated with changes and data requirements
- As well as highlighting the differences in global regulatory expectations
Speakers
Sarah Fitzgerald, Director, Global CMC, Pfizer
Patricia Corrigan, Senior Manager GCMC, Pfizer
CPD
This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.
Cost of webinar recording:
Members: £40.00 + VAT
Non members: £50.00 + VAT
All prices are in pounds sterling and are exclusive of VAT
To register, please log in or create an account, please note recordings will be sent Monday - Friday 9am - 5pm excluding back holidays.
Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.