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Hi There 1. Does anyone know the implementation time of PRAC PSUR assessment report recommendations for a DCP authorized product. I have received a PRAC PSUR assessment report, but I do not see any publication on EC  register. In below Q&A, I see the implementation by NCAs is 30 days from publication. ...

Hi Heidi I took the exam recently and cleared it in my first go. What helped me most are the practice exams. After completing the Fundamentals of Pharmaceutical and Biologics Regulations 4th edition books once, I started going through the practice tests and revised the topics in detail around all ...

Hi Gaurav and Nadim I would like to join the group as well. My mail id is mailsharry@gmail.com. Please include me as well. Many thanks! Sharry ------------------------------ Sharry Arora, M.Ph, RAC Ireland ------------------------------

Hi Anon I have submitted several IND CMC Amendments and have actually never seen an acknowledgement or approval letter from FDA in at least Phase 1 or phase 2 stages. We used to implement the change after 30 days. Not sure if that's how it is about IND amendments with FDA. Others can also share their ...

Hi There The stability data (minimum 1 month) can be provided on any number of clinical batches (minimum 1) manufactured. In addition data on technical batches manufactured before clinical batch manufacture should also be provided. ------------------------------ SHARRY ARORA Loughrea Ireland ...