Profile

Layne Chaya

Contact Details

United States

Contributions

1 to 5 of 5 total
Posted By Layne Chaya 01-Mar-2021 15:56
Found In Egroup: Regulatory Open Forum
\ view thread
Posted By Layne Chaya 11-Jan-2016 09:46
Found In Egroup: Regulatory Open Forum
\ view thread
Hello, I work in animal health PV and my colleagues and I are curious how this would be handled on the human side. Could someone please tell me how you would classify expectedness for an ICSR where the product is used off-label for the indication? For instance, let's say a product like an ...
Posted By Layne Chaya 11-Jan-2016 08:48
Found In Egroup: Regulatory Open Forum
\ view thread
Hi Dr. Lim, Thank you for your reply. I am familiar with the CVM's guidance documents, but unfortunately there is not an explicit answer on this exact question. I was hoping someone could let me know what is customary on the human health side of industry. Thank you again, Layne --- ...
Posted By Layne Chaya 11-Jan-2016 04:48
Found In Egroup: Regulatory Open Forum
\ view thread
Thank you so much! ------------------------------ Layne M. Chaya, VMD Sr. Specialist, Global Pharmacovigilance Merck Animal Health Madison, NJ USA
Posted By Layne Chaya 22-Dec-2015 06:04
Found In Egroup: Regulatory Open Forum
\ view thread
Hello, I am a new member of RAPS and currently work in pharmacovigilance on the animal health side. Is anyone in the forum aware of the best place to find resources on adverse event reporting for my field? It would also be helpful if anyone was aware of a forum specifically for animal health. The ...