QbD: Regulatory and Scientific Possibilities and Challenges

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

  1. The establishment of harmonised guidelines
  2. The Formation of the EMA
  3. The recent document published by the FDA, which is a significant step in dealing with advanced formulations

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


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