15. Future

  1. Sandy Weinberg

Published Online: 8 MAR 2011

DOI: 10.1002/9780470933510.ch15

Book Title

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries

Additional Information

How to Cite

Weinberg, S. (2011) Future, in Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470933510.ch15

Author Information

  1. Atlanta, Georgia, USA

Publication History

  1. Published Online: 8 MAR 2011
  2. Published Print: 28 MAR 2011

ISBN Information

Print ISBN: 9780470552353

Online ISBN: 9780470933510

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CHAPTER TOOLS

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Keywords:

  • the future, and eight strategies for cost containment - auditing, Quality by Design, outsourcing, electronic submissions, FDA and EMEA submissions, control of visits and use of a risk analysis;
  • four major trends within FDA, effects on future of regulation - regulatory cost containment, in pharmaceutical, biologics and medical device industries;
  • impact of four future trends, greater FDA transparency - resources triage, international harmonization and increased regulation on six cost-containment strategies

Summary

This chapter contains sections titled:

  • Predicting the Future

  • Four Major Trends

  • Impact of Future Trends

  • Conclusion

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