QbD: Regulatory and Scientific Possibilities and Challenges Podcast

Dec 02, 2013

iqpc.com

Gert Ragnarsson, Director of the Swedish Medical Projects Agency, discusses the biggest milestones in QbD over the last decade, including:

• The establishment of harmonized guidelines
• The formation of the EMA
• The recent document published by the FDA, which is a significant step in dealing with advanced formulations

Ragnarsson also looks to the future growth of generics and the effects QbD and PAT will have on that market.

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