I want to bring to your attention a Workshop series hosted by PhARMA. Two topic areas: 1) Safety of Potential Risks Associated with Nitrosamine Impurities, and 2) Control Strategies and Inspections/Facility assessments.
With ongoing pressure from US Congress on FDA to resume inspection asap, the topic of Inspections and Facility assessment is quite timely. Really looking forward to hearing from Nitrosamine experts and members of our community @jbercu@kpcross@David … Let’s support them on this forum.
Thank you. Also note that other members of the industry/academic collaboration, the “Nitrosamine SAR workgroup” speaking include: Dr. Krista Dobo (Pfizer) and Dr. Amit Kalgutkar (Pfizer) in addition to Drs. Bercu, Ponting and myself. We are all currently diligently to assemble the latest, most current results to present on these topics.
Hello, thank you for sharing information about this event !
I am quite new in this topic. Could you recommend which part of workshop will cover requirements applicable for biologics?
Thanks Naiffer @Naiffer_Host , Kevin @kpcross for sharing the Workshop invite.
It was such an incredible experience listening to Members from Nitrosamine SAR workgroup, @AndyTeasdale I always admire the amazing Inputs you bring each time into the discussions.
Thankyou for engaging with us. I thoroughly enjoyed the sessions.
Enclosed are the weblinks to the slide deck from both the days.
Looking forward to the next session.
