Academy of Intellectual Property Studies (AIPS) is organizing a one-day workshop on Impurities in Drug Substances – US & Europe Perspective – with a special focus on Genotixic Impurities on January 23, 2010 at AIPS Mumbai.
The AIPS workshop on 'Impurities in Drug Substances – US & Europe Perspective' will study the current regulatory environment in which the drug developers operate, with a special focus on genotoxic impurities. Concerns of the small to mid-sized company, possible strategies that could be adopted while dealing with the regulatory authorities, development and validation of analytical methods to manage genotoxic impurities, study of the recent causes of concern vis-à-vis genotoxic impurities etc will be examined in addition to an overview of the existing official Guidelines and protocols, reporting practices etc.
The workshop is recommended for scientists working in R&D, Regulatory Affairs, Quality Control / Quality Assurance, Toxicology, Manufacturing, Compliance, Preclinical Development etc.
Venue: AIPS, Mumbai.For more details,contact: gita@aips.ac.in or info@aips.ac.in
