BTRA 643 UMUC Practical Applications of Biotech Regulatory Affairs Reflection

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1) Write a  page paper explaining your experience in the regulatory world and what you hope to get out of this course. 

2)Describe the activities involved in the Dosage Form Development through clinical development for (choose one):

  • preformulation
  • formulation
  • preliminary stability
  • package selection
  • formal stability
  • manufacture and packaging for clinical studies   
  • 3) For your first week’s writing assignment, take a look at the attached PDF, which is the introductory guide to the latest version (17.0) of MedDRA. Once you have looked it over, write a 2-4 double spaced page summary of the reasons why MedDRA was originally developed and any interesting features (e.g., lack of alphabetization, need for a common set of descriptors for medical procedures) you find in the current version. 
  • 4) What do you think of the current structure of the ICH? What about the Steering Committee (SC)? Try to focus your answer on questions like “Should the members of the SC change or rotate? 
  • 5) What do you think about the process of harmonization? Is it fundamentally a good idea to try to reduce differences in regulatory policies around the world, or is there a benefit to keeping some differences?

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