The Pharma Letter: Sindusfarma: tirelessly committed to international cooperation and knowledge dissemination

Website: The Pharma Letter

Journalist: Angel Galindo

“In an increasingly globalized world, the exchange of knowledge is crucial for the pharmaceutical industry,” said Nelson Mussolini, Sindusfarma chairman.

“Scientific knowledge is the raw material for development and the exchange of information in the regulatory area, and helps us to standardized norms, opening new horizons for cutting-edge technologies.”

With this in mind, Sindusfarma, the largest representative body of the pharmaceutical industry in Brazil, maintains cooperation agreements with institutions such as the Drug Information Association (DIA), the International Pharmaceutical Excipients Council (IPEC - Americas), Les Entreprises du Médicament (LEEM) and United States Pharmacopeia (USP), writes The Pharma Letter’s Latin American correspondent.

Sindusfarma has also held, in recent years, several important events for the dissemination of technical and scientific knowledge, the discuss relevant topics in healthcare, in pharmaceutical innovation and in relation to providers and services.

The group maintains alliances with recognized international institutions in the areas of science, technology and research and development, in addition to participating in important global events in the pharmaceutical sector.

Sindusfarma does not participate directly in negotiations related to drug import and export agreements, but historically supports international cooperation and commercial exchange initiatives between companies and countries.

For example, it has participated in the debates that resulted in the regulatory harmonization agreements of the member countries of Mercosur (Southern Common Market), currently formed by Argentina, Brazil, Paraguay, Uruguay, Venezuela and Bolivia.

And it has collaborated, for decades, in the staging of the largest business event of the pharmaceutical production chain in Latin America, FCE Pharma, in partnership with the Nürnberg Messe Group, as well as participating in the organization of delegations of Brazilian entrepreneurs major global fairs, such as CPhI Worldwide.

Analyzing new pharmaceutical frontiers

Since 2012, in conjunction with the Industrial Pharmacy Section at the International Pharmaceutical Federation (IPS-FIP) and the National Agency for Sanitary Vigilance (Anvisa), Sindusfarma has held the Symposium ‘New Pharmaceutical Frontiers in Science, Technology, Regulation and Quality System’, which annually brings together, in Brazil’s capital Brasília, dozens of internationally-renowned specialists in panels that debate cutting-edge topics related to the development of the sector in Brazil, such as biotechnology, production of monoclonal antibodies na clinical trials.

In 2019, in partnership with DIA, Sindusfarma promoted the workshops ‘Latin America Medical Information & Communication’ and ‘Latin America Pharmacovigilance and Risk Management’, which have addressed the impacts of data protection regulations on medical information and the importance of planning pharmacovigilance activities.

In the same year, in Miami, USA, Sindusfarma participated in a meeting at DIA ‘Latin America Regulatory Conference’, which discussed the ethical and regulatory challenges of conducting clinical research based on the adaptive study protocols of the international conference.

The dissemination of technical, scientific and regulatory issues related to Good Manufacturing Practices is another focus of Sindusfarma and motivated the establishment of important cooperation agreements.

Committed to keeping standards high

Sindusfarma has a long-standing relationship with IPEC, which has allowed the development of several publications related to excipients for the pharmaceutical industry, including ‘IPEC Guides - Excipients: Good Manufacturing and Distribution Practices’. Meetings held in 2017 and 2018 dealt with the following topics: ‘Technical and Regulatory Updates for Pharmaceutical Excipients’ and ‘Regulation and Technologies for Pharmaceutical Excipients’.

A protocol with the US Pharmacopoeia (USP) has permitted the organization of numerous events on drug quality standards and produced scientific articles, and the alliance with LEEM, a French entity that brings together 260 companies in the pharmaceutical sector and represents 98% of drug sales in the country, has facilitated the exchange of information on European legislation and experiences of the Brazilian and French pharmaceutical industries, and joint participation in public consultations carried out by Anvisa and French regulatory bodies.

Thus, the dissemination of technical, scientific and regulatory issues related to Good Manufacturing Practices, and everything related to research advances and innovation in the pharmaceutical industry, are fundamental for Sindusfarma, as highlighted by Mr Mussolini.

He considers that the dissemination of knowledge is key for global growth and development, so it is essential in these modern times to establish important cooperation agreements.