This Webinar aims to provide a platform for discussion of new policies, procedures and trends in use of CPP/eCPP, to influence regulators in Latin America and the Caribbean to adapt their national procedures to rationalise and streamline the use of CPP/eCPP, when applicable. This exchange of information is beneficial to both regulators and companies, representing a clear area of cooperation between different stakeholders.

Target audience: 

Regulators, industry associations and companies in Latin America and the Caribbean.

Background information:

In the last years, reference regulatory authorities (EMA, FDA, etc.) have been introducing important changes in the way they issue the Certificates of Pharmaceutical Product (CPP) used by many regulators around the world in regulatory submissions. Nevertheless, not all regulators in emerging markets are aware of these changes and the rationale for their implementation, which has a huge impact in some regulatory submissions, potentially disrupting the supply of medicines or even preventing timely access to medicines by patients.

In Latin America and the Caribbean, some regulators could have adapted their requirements concerning to the CPP, not only because of the COVID-19 pandemic, but also because of new procedures and policies implemented both by the European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA). Moreover, companies have identified that regulatory processes in the region might not be fully aligned to the updated best practices recommended by the World Health Organisation (WHO) related to the use of CPPs and eCPPs.

Featured speakers include:

• Alberto Ganan, European Medicines Agency
• Mandy Zeigler, Pfizer
• Samvel Azatyan, World Health Organisation