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Regional Health Sector and Regulatory Experts Meet at Seventh PANDRH Conference

National health authorities, health experts, civil society and pharmaceutical industry representatives, and national regulatory authorities (NRAs) from the Region of the Americas and other parts of the world met in Ottawa, Canada, from 5 to 7 September 2013 for the Seventh Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). The purpose of the conference was to promote drug regulatory harmonization, strengthen regulatory capabilities and convergence, promote health surveillance, and coordinate evaluation of a strategic development plan for the Network.

The theme of the three-day meeting was "16 years promoting good regulatory practices in the Region of the Americas," and participants stressed the need for a governance mechanism that can effectively respond to changes in health regulations, promote medicines regulation through innovative research, and implement strategies that promote access to good-quality, safe, and effective medicines and health technologies. The participants also noted the importance of developing mechanisms for information exchange to facilitate the work of regulatory agencies and make health products safer through ongoing cooperation among countries.

The main topics of the conference included improving network governance; active NRA participation in efforts to foster convergence and drug regulatory harmonization; adopting strategies and mechanisms for drug regulatory harmonization and convergence; strengthening competencies in good regulatory practices and regulatory science; and promoting the sharing of regulatory experiences and know-how among NRAs.

Foto grupal VII Conferencia de la Red PARF

Sessions were also held on the Region's progress and challenges in the fields of medicines surveillance and patient safety, counterfeit medicines, biotherapy products, and the regulation of medical devices and bioequivalent medicines.

At the end of the meeting, the participants agreed on the need to establish a new governance structure for PANDRH that reorganizes the Network's operations and coordinates its work with other international drug regulatory harmonization and convergence initiatives. Another proposed agreement was the adoption of a systematic mechanism for setting priorities based on a periodic analysis of the situation and needs of NRAs.

The participants also recommended that a competency-based curriculum and comprehensive capacity-building plan for the staff of regulatory agencies be developed that reflects the Region's different realities and diversity, and that streamlined information exchange be established between network members and other regulatory agencies through knowledge management instruments to support the new PANDRH strategic plan for 2014-2020.

VII PANDRH Conference: Important documents 

pdf Agenda

pdf   pdf Opening Remarks - James Fitzgerald - PAHO/WHO

Strategic objectives sessions

Thematic sessions

pdf VII PANDRH Conference: Recommendations and next steps

Recently added

Strategic objectives sessions

Promote effective governance of PANDRH and active participation of NRAs towards regulatory convergence and harmonization

pdf  Overview of ICH Governance: Lessons Learned - Michele Limoli - US FDA (1.69 MB)

pdf  Governance Models of other networks: APEC and IMDRF - Mike Ward - Health Canada (2.64 MB)

pdf  Overview of the EU regulatory system and governance -Alexios Skarlatos - EMA (1.57 MB)

pdf  Overview of African Medicines Registration Harmonization Initiative (AMRH) - Samvel Azatyan - WHO (1.25 MB)

Defining priorities, strategies and mechanisms for regulatory convergence and harmonization

pdf Defining priorities, strategies and mechanisms for regulatory convergence and harmonization, and supporting their dissemination, adoption and implementation by NRAs - ANVISA and FDA (1.39 MB)

pdf  Overview of regulatory capacity and NRA priorities based on PRAIS data and NRA survey - Murilo Freitas - PAHO/WHO (3.64 MB)

pdf  The objectives and development of a joint NRA assesment tool - David Wood - WHO (1.9 MB)

Promote the strengthening of competencies in Good Regulatory Practices and Regulatory Science

pdf  Good Regulatory Practices : regional reference NRA - Mikel Arriola - COFEPRIS (4.47 MB) *

pdf  Strengthening good regulatory practices based through evaluation on regulatory capacity Miriam Naarendorp - NRA Suriname (6.14 MB)

Promote the exchange of experiences and regulatory knowledge between National Regulatory Authorities

pdf  Promote the exchange of experiences and regulatory knowledge between NRAs - Sebastián Duarte - ANMAT and Maryam Karga-Hinds-Barbados Drug Services (1.54 MB) *

pdf  Lessons learned from international effective cooperation agreements: Regional reference NRA (418 kB) *

pdf  COFEPRIS cooperation with El Salvador - José Coto - NRA El Salvador (4.23 MB)

pdf  Networking in Regulatory Capacity Building for Vaccines - Catherine Parker - Health Canada (1.36 MB)

pdf  Pharmacovigilance Community of Practice in PRAIS - José Luis Castro -PAHO/WHO (2.73 MB)

pdf  Lessons learned from international effective cooperation agreements TECHPHARM - Maryam Karga-Hinds -Barbados Drug Services (169 kB)