AGAH-Workshop: Reproductive Toxicity

The interpretation of findings from studies on reproductive and juvenile toxicity is a challenging task in drug development. What do we understand about the predictivity of animal studies when it comes to clinical development, especially as drugs may be developed for infants, children, adolescents as well as for women and men in their reproductive age? Can we distinguish findings without likely impact on human reproduction and postnatal development from those which have a potential noxious effect? How can we use the various types of studies on reproductive and juvenile toxicity to identify and differentiate these from each other? How should adverse reproductive toxicity findings be handled in the process of developing drugs for a variety of indications with respect to the mitigation of potential risks to human reproduction? What are the respective ethical implications?

This AGAH workshop will address these questions with experts in the field taking into account the recent Guidance for the Industry issued in 2011 by the US FDA. Break-out sessions regarding specific types of studies on reproduction and juvenile toxicity are planned to delve into a deeper understanding gained from plenary sessions.

The workshop will conclude with feedback from the break-out sessions and an open floor Q & A session.

It is the aim of the workshop to provide up to date information on recent developments in assessing reproductive and juvenile toxicity and to discuss their practical implications.