Tuesday, November 8, 2022 - 10:00am to 12:00pm EST
Nanomaterial
continues to be a hot topic among regulatory agencies globally. The
recent ban on TiO2 (E171) as a food additive in Europe has highlighted
the need to have a comprehensive understanding of the global regulatory
environment related to the presence of nanoparticles in food additives
and excipients. The use of TiO2 in pharmaceutical and cosmetic
applications is under review in the EU. There has not been any specific
safety concern which has been scientifically demonstrated for E171 and
the current ban in food is based on the precautionary principle and some
uncertainties related to genotoxicity.
In Europe similar concerns have been voiced for many other food additives which are also excipients.
The
regulatory and safety implications for the inclusion of these materials
(containing a nanoparticle fraction) in pharmaceutical products is not
clear. If these materials were to be banned in pharmaceuticals, the
implications to patients could be severe (potential loss of life-saving
medicines).
This webinar provided an overview of the current
situation related to TiO2 and other identified excipients containing
nanoparticle fractions. In addition, a discussion of current regulatory
and industry activities and their potential impact will be summarized.
Learning/Awareness Objectives
Attendees were provided with:
> Background, overview and definitions of excipients containing nanoparticle fractions
>
Current regulatory activities in the EU and other countries which may
impact the use of these materials in pharmaceutical products
> Understanding of the extent of materials potentially impacted
> Current situation as it relates to TiO2 and potential alternatives
> Potential impact for patients, regulators and the industry
> Industry activities to proactively address these issues
Who should attend?
> Pharmaceutical formulators and development scientists
> Excipient manufacturers
> Regulatory affairs and legal professionals
> Safety evaluation professionals
> Compendial affairs
> Quality affairs