This group focuses on regulatory sciences in the field of bioequivalence, in-vitro dissolution, biosimilars and quality in different regions. If applicable, the group will strive for harmonisation of requirements. Education in new analytical technologies is also within our scope, and we will consider interest and relevance to practitioners in various settings.
The SIG evaluates regulatory guidance prepared by various agencies and provides sponsors of new drug products with the science-based information they need to apply for a marketing authorisation.
The regulatory sciences encompass a wide scope of activities, ranging from laboratory work to support drug product quality through pharmacokinetics and pharmacodynamics to post-marketing surveillance.
In the future, this special interest group will also consider aspects, such as medical devices, digital technologies, nanomedicines, and other innovative trends looking into integrated health care. For these innovative trends new analytical technologies have to be applied. Powerful analytical tools are also required to combat substandard and falsified medicines.
How we work
The special interest group is chaired by Dr Horst-Dieter Friedel (Germany).
For more information about this group or to get involved, email RegSciencesQuality@fip.org