In September, Interfarma launched its KEEN Program (KnowledgE ExpaNsion Program), partnering with ANVISA”s Clinical Research Coordination (COPEC). The Discussion Forum first module was held in September focusing on RBM (Risk-Based Monitoring). The second module, “Quality, Production and Development”, took place in November and December.
Since the beginning of 2020, Interfarma’s Regulatory Affairs Team, through its Clinical Trial Commission, works in partnership with COPEC, aiming to identify priority issues within this Coordination that will help improve performance and agility at ANVISA`s analysis of clinical protocols. To this end, Interfarma, with collaboration from its Clinical Research Commission, proposed
holding virtual forums with both national and international specialists, aiming to assist in expanding the knowledge of ANVISA and the industry’s technicians and specialists.
The subjects were split into three stages:
Short term (September/2020): RBM (risk-based monitoring);
Medium term (November/2020): Quality, Production and Development;
Long term (1st half of 2021): Clinical Development Optimization, Comparators, Vaccines, Rare Diseases, Statistics and Biosimilars.
The virtual forums are all recorded. First module videos on RBM are already available on Interfarma“s YouTube channel.