CMC Pharma Regulations MasterClass

We are organizing the CMC Pharma Regulations MasterClass on the 27th and 28thof September, 2018 in Vienna, Austria, led by Dr Andreu Soldevila, CEO of Leanbio. The CMC Pharma Regulations MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for the clinical trial, registration and post-approval drug applications. 

By the end of the MasterClass, the participants will understand:

i) Process development strategies

ii) Analytical and Formulation development

iii) GMP manufacture

iv) Process analytical Technology

v) Guidelines and Regulatory pathways for New Biological entities and Biosimilars

For the training description, detailed trainer profile and training program,  please request the Training Agenda.