The IX Conference of the Pan American Network on Drug Regulatory Harmonization (CPANDRH) was held in El Salvador from October 24th-26th, 2018. The meeting, entitled “Contributions of regulatory harmonization in the achievement of health for all,” commemorated 20 years of the PANDRH Network (Pan American Network on Drug Regulatory Harmonization) and 40 years of the Alma-Ata Declaration of 1978. The Network is a joint initiative of the National Regulatory Authorities of the Region and the Pan American Health Organization (PAHO) to support the harmonization of pharmaceutical regulation in the Americas.
The meeting was organized by the National Drug Directorate of El Salvador, in coordination with PAHO, and was attended by more than 300 healthcare leaders from 35 countries in Latin America. Following previous conferences in Ottawa and Mexico, this year’s event continued the discussion on strengthening of regulatory systems in the region.
FIFARMA promotes and supports the work of the PANDRH Network. In fact, in December 2017, the Executive Committee of the PANDRH Network approved the first joint initiative between PANDRH, FIFARMA and Cuba’s National Regulatory Authority (CECMED), titled “Evaluation of the Requirements of the Pharmaceutical Product Certificate (PPC) for registration processes in the Region of the Americas, towards more timely access to medicines and more convergent regulatory approaches.”
During the IX PANDRH Conference, four prominent panelists representing FIFARMA presented and provided highly appreciated contributions and updates:
- Plenary Session 4: Transparency and information for decision making
Cristina Mota Pina, Director, Scientific Regulatory Policy and Intelligence – Latin America AbbVie, presented on transparency, stakeholders responsibilities and participation in regulatory processes:
“…Because at some point in life we are all patients, we must guarantee transparency in everything we do.”
- Plenary Session 5: Improvement of regulatory capacities
Thomas Schreitmueller, Global Head Regulatory Policy at F. Hoffmann – La Roche AG, Switzerland, shared the industry perspective on strengthening the regulatory system in the region:
“..The increasing speed of scientific progress, our understanding on the underlying causalities of diseases and as a result the availability of innovative healthcare solutions make the need for strong and efficient regulatory systems more urgent than ever before”
- Plenary Session 6: The use of information in regulatory convergence
Jaime Oliveira, Head Regulatory Policy and Intelligence at Bayer Latin America, provided an update on the PANDRH Project (evaluation of CPP requirements for the registration of medicines):
“…The CPP project has reached a steady pace and gained great visibility in the Region and also globally through the WHO. This is the result of the work of the project’s coordinators, CECMED/Cuba and FIFARMA, and also of the engagement of National Regulatory Authorities and industry’s trade associations in the region of the Americas. We expect important outcomes from this project and that it becomes a concrete example that regulators and industry can work together to reach convergent objectives”.
- Plenary Session 7: Regulatory approaches based on risk in all regulatory functions
Denise Bonamici, Head of Regulatory Science & Policy – Latin America at Sanofi, presented topics on risk management for regulatory purposes:
“…We see encouraging examples of trust, shared work and efficient use of resources in our region.”
Authors: Thomas Schreitmueller, Global Head Regulatory Policy at F. Hoffmann – La Roche AG, Switzerland and María Alejandra De Guzman – FIFARMA Communications Manager