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Books in Pharmacy management

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Regulatory Affairs in the Pharmaceutical Industry

  • 1st Edition
  • November 14, 2021
  • Javed Ali + 1 more
  • English
  • Paperback
    9 7 8 - 0 - 1 2 - 8 2 2 2 1 1 - 9
  • eBook
    9 7 8 - 0 - 1 2 - 8 2 2 2 2 3 - 2
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

Practical Leadership for Biopharmaceutical Executives

  • 1st Edition
  • May 5, 2011
  • Jane Y Chin
  • English
  • eBook
    9 7 8 - 1 - 9 0 8 8 1 8 - 0 2 - 7
The biohealthcare executive in upper-middle management confronts leadership challenges unique to their industry: they manage highly specialized knowledge workers and innovators, compete at the speed of technology, work in a highly regulated environment where "free speech" often does not apply due to patient safety and privacy concerns, and increasingly are leading virtual teams who may be located in different parts of the world. Practical leadership for biopharmaceutical executives is a guide that strips away the theory and meets head-on the practical leadership challenges these executives face on a daily basis, and provides these "innovator leaders" with the tools to lead effectively in the face of technological complexity.