Pharma Extractables and Leachables 2012 (Pharma Extractables )

Venue: The Lalit

Location: Mumbai, Maharashtra, India

Event Date/Time: Aug 21, 2012 End Date/Time: Aug 23, 2012
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Description

Pharma Extractables and Leachables 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:

Regulations
• Clarifying and updating on PQRI, EMEA, FDA, ASEAN and Japanese guidelines with practical case study insights
• Understanding methods of approach and specific documentation for E&L
•Learning best practices to charaterise and assign limits to extractable and leachable impurities

Analytical
•Cost effective and time saving analytical techniques of identification and extraction of extractables and leachables
•Safety qualification process and overcoming challenges around low level of quantification (LOQ)
•Toxicological Risk Assessment

Venue

The Lalit
Sahar Airport Road, Andheri East
Mumbai
Maharashtra
India
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