Dear anonymous,
I have 10 years experience in planning and conducting clinical research supported by extensive education( Regulatory Affairs Certificate: Pharmaceutical and Device Dual, CCRP and PMP). I can assist in global submissions and preparing documentation and processes for clinical trials conduct, site management and data management according to applicable regulatory requirements to support marketing applications.
If you like to discuss this further, Please contact me at
khurshidumaira@gmail.com.
Thank you,
Sumaira Khurshid
Regulatory Affairs Specialist
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Sumaira Khurshid
Ancaster ON
Canada
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Original Message:
Sent: 21-Nov-2017 13:30
From: Anonymous Member
Subject: global pathway planning for drug-device combination product
This message was posted by a user wishing to remain anonymous
Hi colleagues,
I'm looking for a consultant with experience in planning clinical studies and market authorization pathways globally for a drug-device combination product. We are looking for experience on best practices, common pitfalls, etc. from someone with experience in drug-device combination products specifically.
Thank you