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. |
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| 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. |
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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. |
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| Attend Pharma Extractables and Leachables 2012 taking place from 21-23 August 2012 and prepare for SAVING ON HUGE COSTS |
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| Dont miss out on this must-attend conference that will delve deeper into: |
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| Regulations |
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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
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| 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
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Plus a unique pre-conference seminar on E&L challenges in formulations covering indepth insights on: |
- Understanding the importance of extractables and leachables study and sucessfully dentifying its potential sources
- Undertaking successful compatibility study of product with its packaging material
- Adopting a systematic quality control approach for new product development
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| A not-to-be-missed event for practical knowledge seekers including Directors, Senior Directors, Heads, Presidents, Vice-Presidents, Senior Managers, Managers, General Managers in the field of Regulatory
Affairs, QA/QC, R&D and Formulations Development |
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