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Strategic objectives sessions

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

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

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

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

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

  • Defining priorities, strategies and mechanisms for regulatory convergence and harmonization 

icon 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)

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

icon 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

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

icon 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

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

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

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

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

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

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

 



Last Updated on Wednesday, 22 January 2014 12:21
 

 

Bioequivalence  

Biotechnological Products

Counterfeit medicines

Good Clinical Practices

Good Laboratory Practices

Good Manufacturing Practices

Medical Plants

Medicines Classification 

Medicines Promotion

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Pharmacopoeia 

Pharmacovigilance

Vaccines

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