Wednesday, January 17, 2024 - 11:00am to 1:00pm EST
Featuring
Mr.
David Schoneker – IPEC-Americas Quality by Design Committee Chair,
President/Owner of Black Diamond Regulatory Consulting, LLC
Description
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
focused 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.
Learning/Awareness Objectives
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
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.