Bioequivalence: New trends and recent discussions
The future is harmonization: ICH M13 paves the path for a globally uniform approach – a path with many controversial discussions but also innovative ideas.
With our workshop we want to show that the topic is still exciting. We will introduce you to the current state of the international discussions of harmonisation, focus on some burning open issues and we will show future approaches that have a chance to contribute to international modern trends.
Good and sustainable bioequivalence studies thrive on a design that covers current and future regulatory requirements and on a quality approach that ensures regulatory acceptance. We have put together presentations for you that will still provide new insights even for professionals and at the same time give a good overview of the current status.
Get involved with our event: Our history at SocraTec R&D and SocraMetrics is rooted in bioequivalence! Thus, it is more than plausible to start our Anniversary Workshop Series with this topic, even though today our spectrum is of course much broader.
We look forward to welcoming you to join us.
ICH M13: Old wine in new bottles - or cornerstone for advanced BE regulations?
Frankfurt Foundation Quality of Medicines
ICH M13A: Testing for multi-group and multi-center – effects in BE trials: Statistical considerations and consequences for interpretation
BEBAC Consultancy Services for Bioequivalence & Bioavailability
ICH M13A: Endogenous substances and the heterogeneity of physiological baselines – what does this mean for study design and evaluation?
SocraTec R&D GmbH
ICH M13C: Narrow Therapeutic Index Drugs – ideas for alternative strategies
The future: Can PopPK modelling and simulation support generic development?
qPharmetra / Freie Universität Berlin
Manipulation of BE trial outcomes: A potential serious risk to public health
Registration is closed.
Airport Club Frankfurt GmbH
Frankfurt Airport Center I
60549 Frankfurt am Main