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Drug Development Project Mgmt

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Drug Development The process to bring a new drug to market Contributors: Lindsey LaRue, Chris Stearns, and Sirisha Karri
Who we are? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Scope of Work ,[object Object]
Milestones ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Schedule/Timeline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Budget ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Budget - NME ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Budget - NME
Budget Breakdown ,[object Object],[object Object],[object Object],[object Object],[object Object]
Budget Breakdown ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Possible Risks ,[object Object],[object Object],[object Object]
Preventing Risk ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Assessment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Quality Assessment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Drug Development Project Mgmt

  • 1. Drug Development The process to bring a new drug to market Contributors: Lindsey LaRue, Chris Stearns, and Sirisha Karri
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 10.
  • 11.
  • 12.
  • 13.
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Notes de l'éditeur

  1. Adverse effects
  2. 1). Active surveillance (eg, medical records reviews, patient or physician interviews, prescription event monitoring, data from disease or drug exposure registries). Further clinical studies (specific safety studies, larger studies over longer periods). Drug utilization studies (which describe how a drug is marketed, prescribed, and used in a specified population ﾑ o ften stratified by age, gender, concomitant medications, etc ﾑ a nd how these factors influence clinical, social, and economic outcomes Restricted use of the medicine (eg, for use/dispensing only in hospital, or where specific equipment [eg, resuscitation equipment] is available; availability only in limited unit sizes) Mitigating to reduce risk, no way to completely remove or avoid
  3. Verbally summarize scope of work from previous slide