Profile

We can ask them, EP, and ICH. If there is consensus to develop this idea further, I suggest we get together to refine the concept. Rob

I have a suggestion. Many of us in this group face data uncertainty when preparing regulatory submissions. How about creating a mini course based on ICH and other sources identified during this conversation? Creating this course could benefit both our community and regulatory affairs professionals. Best, ...

Hi Allison, Because of my work, I follow the following reg. agencies - FDA, HC, MHRA, EMA and NMPA and the following entities: ICH, WHO and OECD. And I am presently working with University of Hertfordshire on global regulatory harmonization projects along with TOPRA and RAPS. So, I will be interested ...

Hi, I am interested to help. Thanks, Rob ------------------------------ Robert Falcone PhD, FRAPS, FTOPRA Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer. ------------------------------

Hi Allison, Thank you for your leadership on these initiatives. I am especially interested in CMC regulatory topics for both small and large molecules, with a focus on cell and gene therapies and the use of AI in CMC work. I hope this opens up opportunities to connect with the CMC group. Best, ...