19 - 21 September, 2011, Four Points by Sheraton, Brussels, Belgium
Register by 24th June 2011 and receive up to €450 off!
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The bioequivalence approval process is now faster, easier and cheaper than ever before but are you taking full advantage of these benefits to ensure that your products reach the market as quickly and cost effectively as possible?
Pharma IQ’s 2nd Annual Bioequivalence and Bioavailability Studies conference will highlight the challenges and successes of the 2010 EMA guidelines, outline effective strategies for ensuring compliance, provide practical case studies on optimising study design, increasing biowaiver success rate to speed time to market and decrease costs as well as providing in-depth insights into the future challenges of modified release products.
Download the brochure here for all the details and full speaker line up.
Helmut Schutz and Anders Fuglsang
One Year On: The Bioequivalence Guidelines Helmut Schuetz of BEBAC Consultancy and Anders Fuglsang of Fuglsang Pharma Consultancy, join Pharma IQ to discuss the impact of the bioequivalence guidelines introduced in summer 2010 on the pharmaceutical industry.
1. Receive regulatory clarification of the bioequivalence submission criteria to ensure compliance and speed time to market
2. Be prepared for the new modified release guidelines
3. Make informed decisions before starting your studies through effective use of in vitro testing and establishing IVIVC
4. Optimise study design by understanding the two stage approach
5. Successfully secure a biowaiver with tips from the regulators and clarification of the biopharmaceutical classification system
6. Overcome the challenges of establishing bioequivalence for highly variable drugs
7. Address the implications for industry of the draft bioanalytical guidelines
8. Translate results to clinical relevance using modelling and stimulation tools
9. Interactive roundtable sessions - gain further in-depth knowledge in your chosen subject area
10. Interact and network with your colleagues and peers in our dedicated networking sessions!
Very good to hear the assessor's views on the subject.
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