Priscilla Zawislak - Global Regulatory Affairs Advocacy Manager, IFF
This webinar was intended to provide a summary of the current regulatory situation for excipients in Latin America and possible future developments. IPEC-Americas has been working with our partners in Latin America to have IPEC guidelines translated into local languages and has presented educational workshops for several years in this region to regulators and industry associations. Some countries have established regulations for excipients, e.g. ANVISA in Brazil has regulations for excipient GMPs, while other countries' regulations do not specifically address excipients.
After the webinar, participants will:
> Understand various regulatory requirements for suppliers and drug product manufacturers in Latin America.
> Gain a perspective on how other regions operate.
> Learn about IPEC-Americas efforts to engage and educate on best practices.
Who should attend?
> Excipient manufacturers, users, distributors
> Regulatory affairs
> Compendial affairs
> Quality affairs