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Ahmed Abouelnour, MSc, RAC, BPharm

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Canada

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1 to 5 of 9 total

RE: Multiple routes of administration

Posted By Ahmed Abouelnour 29-Jan-2018 17:35
Found In Egroup: Regulatory Open Forum \ view thread
Hi Wes  There are some examples of approved products that used with multiple routes of administration. I would suggest if you visit either the review reports (on FDA) or the Public Assessment Reports (in EU) for these products to get more idea. You can also reverse engineering these review reports ...

Korean Port-Approval Change

Posted By Ahmed Abouelnour 03-Aug-2017 10:18
Found In Egroup: Regulatory Open Forum \ view thread
Hi  I wish if i can get the requirements for Korean post approval changes either in English or Korean  Thanks  Ahmed ------------------------------ Ahmed Abouelnour RAC Etobicoke ON Canada ------------------------------

RE: Hong Kong

Posted By Ahmed Abouelnour 04-Jun-2017 21:12
Found In Egroup: Regulatory Open Forum \ view thread
Hi Paul  I actually navigated through the HK regulatory environment during the last week and I found it quite simple. There is no regional complications that may need a local consultation partner. I made a sheet that was based on my scope of search in HK (I attached a copy). I wish that information ...

RE: Hong Kong

Posted By Ahmed Abouelnour 04-Jun-2017 21:11
Found In Library: Regulatory Open Forum

RE: MDSAP Questions

Posted By Ahmed Abouelnour 31-May-2017 22:10
Found In Egroup: Regulatory Open Forum \ view thread
In Canada, The legal manufacturer is the design owner. It doesn't matter who is the distributor (if it is a third party). You company (legal manufacturer) will require the MDSAP to maintain the licence of the approved products. I think the scope of MDSAP will be depending on the class of products . ...