Profile

Hi Anon, Thank you for sharing your situation. From what I have seen as you make the jump to the next level soft skills become more important. Things like Strategy, negotiation, business acumen and talent management and development are some of the skills I can recommend developing. I am glad that you're ...

I think RAPS offers a Project Management course for Regulatory professionals. Please see link below. https://www.raps.org/products/project-management-for-regulatory-professionals-40-rac ------------------------------ Mehul Govani RAC Regulatory Affairs Manager PL Developments Westbury NY United ...

You may not be alone. I just saw an article which talks about the same issue. https://www.lachmanconsultants.com/2023/08/the-curious-case-of-the-latecycle-amendment-under-gdufa-iii/ ------------------------------ Mehul Govani RAC Regulatory Affairs Manager Westbury NY United States --------- ...

Good observation Sujan. I think there was another MAPP 5241.3 Good Abbreviated New Drug Application Assessment Practices that was released on October 6, 2023 which aimed at making OGD reviews more efficient by focusing on critical areas. I think this MAPP 5200.14 was updated as a result of that. In my ...

I have worked with PharmaReady software. The software is user friendly and the support team is very helpful. Their pricing is decent too. https://www.pharmaready.com/ ------------------------------ Mehul Govani RAC Regulatory Affairs Manager Westbury NY United States ---------------------- ...