Back to Agendas
SESSION 2
Session Chair(s)
Tomas Salmonson, DrMed, PhD
Partner
Critical Path Institute, United States
This session includes a look at the new ICH quality topic (Q12) being developed to facilitate post-approval changes, promote innovation, quality management and continual improvement throughout the lifecycle. It will also review of initiatives in the area of nonclinical rodent carcinogenicity studies, where an effort to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals is being made (S1).
Speaker(s)
Q12 Pharmaceutical Product Lifecycle Management
Graham Cook, PhD
Pfizer Global Quality Intelligence and Compendial Affairs, United Kingdom
Senior Director
S1 Regulatory Notice Document on the Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals
Jan Willem van der Laan, PhD
Medicines Evaluation Board, Netherlands
Senior Assessor Pharmacology and Toxicology
Have an account?
Ways to register
Government/academia/charitable/non-profit (full time) employees are welcome to attend this event free of charge.
GOVERNMENT/ACADEMIA/CHARITABLE/NON-PROFIT (FULL TIME) attendees are kindly requested to fill out the registration form available at the back of the programme (click on View PDF) and send it to diaeurope@diaeurope.org.
Please note that there are limited places available for government/academia/charitable/non-profit attendees.
INDUSTRY attendees are kindly requested to register online or by filling out the registration form.
Registration fee includes delegate material and morning coffee break.
This event has limited capacity. Register early!