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 will provide 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.
Attendees will be 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