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Global Regulatory Affairs CMC: Chemistry, Manufacturing and Controls Conference



 
Our Price: $495.00

Product Code: 2295
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About the Product
Includes presentation materials from the conference. Presentations slides are in PDF. format. All files are available for immediate download.

About the Global Regulatory Affairs CMC: Chemistry, Manufacturing and Controls Conference:

Ensuring Successful CMC Submissions throughout the Product Lifecycle through Recognizing the Follow-on Impact of Pre-Approval Decisions on Post-Approval Activities, with an Emphasis on Evolving International, Non-Tier 1 Regulatory Structures

As pharmaceutical corporations continue to develop and market therapies around the world, ensuring compliance with evolving regulatory chemistry, manufacturing and controls is increasingly difficult throughout the product lifecycle. From initial dossier submission documents to support product approvals to the documentation and submission of change controls impacting CMC in post-approval scenarios, regulatory CMC executives face a tremendous number of regulatory structures, with restricted harmonization and unclear timelines which impact the overall product supply chain. Gaining insight into best practices from leading corporations, the Q1 Global Regulatory CMC Conference provided a singular, unique opportunity for executives to discuss and debate CMC regulatory structures throughout the product lifecycle.

Post-approval CMC changes received a special emphasis during the program, while the sessions on pre-approval submission preparations focused on the follow-on impact that early-decision making has on future CMC submissions. International regulatory frameworks were also a considerable focus for this program, with progressive case studies that highlighted successful management of CMC filings in countries and regions including Brazil, South America, Asia and the Middle East. Regulatory experts also provided insight into harmonization efforts in Tier 1 countries and regions, providing a forward thinking approach to the next generation of CMC regulatory requirements.


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