Member login

E-mail address:

Password:
Remember me

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
More info >>

Time lapse photography to demonstrate the potential antimicrobial abilities of Dycem contamination control flooring

Dycem

A defined volume of bioluminescent reporter bacteria was deposited onto 20 mm x 20 mm coupons of Dycem flooring, vinyl tile and ITW Alma tacky mat. Through monitoring of bacterial bioluminescence, metabolic inhibition was observed on all three surfaces however the effect occurred more rapidly on Dycem flooring than on vinyl or ITW Alma. Recovery counts after three hours of exposure to the floor surfaces showed between a 65% and 100% decrease in the number of viable organisms recovered from Dycem flooring compared to controls. On vinyl and ITW Alma flooring, there were slight increases in the number of viable survivors recovered compared to controls. Dycem flooring inhibited the metabolic activity and reduced the number of viable survivors recovered of Salmonella enterica Serovar Typhimurium DT104 pGLITE. It remains unclear as to whether this effect is attributable to the impregnated biocide or rapid drying of the inoculum on this surface.
More info >>

LogiPharma 2019

9-11 April 2019, Montreux Music & Convention Centre

LogiPharma is the world’s leading pharma supply chain event. With over 950+ pharma supply chain leaders exclusively meeting in one place at one time, LogiPharma is THE meeting place to benchmark your business with the best pharma companies and shape the future of your industry.
More info >>