Mr. David Schoneker – IPEC-Americas Quality by Design Committee Chair, President/Owner of Black Diamond Regulatory Consulting, LLC
The European Medicines Agency is evaluating a ban on TiO2 in pharmaceutical products by 2024. Although credible scientific studies indicate that TiO2 is safe for food and drug use, a ban is still being considered.
Pharmaceutical companies are evaluating the possibility of utilizing TiO2-free film coatings and have found there to be many challenges. TiO2 provides uniform appearance and serves as an effective opacifier to help mitigate the photostability risk of a drug substance. TiO2-free film coats with an alternative opacifier, such as CaCO3, rice starch, and MgCO3, may pose risks for drug product development.
This webinar will focus on the actual safety situation with TiO2, the potential use of TiO2-free coatings, and the associated challenges being faced by the industry, regulators and patients, if TiO2 were to be banned in pharmaceutical applications.
Attendees will be provided with:
> The current solutions available for Titanium Dioxide free film coatings - benefits and limitations
> Current regulatory activities in the EU and other countries which may impact the use of TiO2 in pharmaceutical products.
> Education on the challenges gained through industry experience.
Who should attend?
> Pharmaceutical formulators and development scientists
> Excipient manufacturers
> Regulatory Affairs and legal professionals
> Safety evaluation professionals
> Compendial Affairs
> Quality Affairs
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Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.