Extractables and Leachables Conference 2013

After the overwhelming response for our Mumbai and Hyderabad event, CPhI is now delighted to bring to you Pharma Extractables and Leachacbles Conference 2013 taking place from 24-26 July in Mumbai.

With 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.

This year the focus will be on practical case studies covering:

Step- wise approach of performing E&L study for PODP, OINDP’s and ophthalmic
Identifying E&L from production process or intermediate storage and integrating QbD with E&L approach
Updates on PQRI recommendations for E&L in combination products and biologics
Discussion on the USP chapter for E&L and developing a tactical approach
Importance of selecting the extraction techniques & establishing the significance of Analytical Evaluation Threshold (AET)
Toxicological review in E&L data and risk mitigation strategy to reduce or tackle E&L