Academy of Intellectual Property Studies (AIPS), Mumbai is organizing a one-day seminar on the ICH Guideline on Q11 relating to the development and production of drug substances on September 7, 2012 at AIPS. The seminar aims to provide clarification on the principles and concepts described in ICH Q11 as they pertain to the development and manufacture of a drug substance.
AIPS is an institute that has been set up in affiliation with the Indian Drug Manufacturers Association (IDMA), and is conducting this seminar for the first time, as it is a relatively new topic and no guidance is available for the regulatory affairs people, APIs and R&D, quality assurance and quality control.
In this one-day symposium, the experts will discuss the current approach versus expectations as per Q11. The workshop will commence with an introduction to the Q11 concept. The faculty from R&D and regulatory affairs will address topics such as the drug substance manufacturing process development, selection / qualification of KSM for synthetic drug substance, critical quality attributes and control strategy, process validation and evaluation, Q8 Q9 and Q10 vis-a-vis Q11 etc.
The presence of executives from Research & Developement (R&D) departments of API manufacturers, quality assurance, quality control and regulatory affairs in the seminar will be a good learning experience.
For further details, contact: Gita Chandrashekhar on 2874 6123/6522 1097, or e-mail:gita@aips.ac.in