Pharma Extractables and Leachables 2012 (Pharma Extractables )
Venue: The Lalit
|Event Date/Time: Aug 21, 2012||End Date/Time: Aug 23, 2012|
With the ever-growing regulatory complexities and unclear guidelines around extractables and leachables, pharma companies are struggling to identify cost-effective solutions for fulfilling regulatory expectations and achieving swift product approvals. Also, a number of products requiring E&L studies are soon going off patent and hence, generic companies are looking at feasible solutions to minimise their costs for E&L testing.
Now is the right time to prepare for the future and revamp your strategies to avoid incurring huge losses due to inappropriate and untimely E&L studies.
Attend Pharma Extractables and Leachables 2012 taking place from 21-23 August 2012 and prepare for savings on huge costs.
Dont miss out on this must-attend conference that will delve deeper into:
â€¢ Clarifying and updating on PQRI, EMEA, FDA, ASEAN and Japanese guidelines with practical case study insights
â€¢ Understanding methods of approach and specific documentation for E&L
â€¢Learning best practices to charaterise and assign limits to extractable and leachable impurities
â€¢Cost effective and time saving analytical techniques of identification and extraction of extractables and leachables
â€¢Safety qualification process and overcoming challenges around low level of quantification (LOQ)
â€¢Toxicological Risk Assessment