12 research outputs found
Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers.
No full textIn the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa's regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives-the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)-as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products
Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers
No full textIn the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa’s regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives—the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)—as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products
Questions asked during interviews of MRH initiative participants.
No full textQuestions asked during interviews of MRH initiative participants.</p
Questions asked during interviews of industry representatives.
No full textQuestions asked during interviews of industry representatives.</p
The four medicines regulatory harmonization initiatives featured in this study are coordinated by the four corresponding regional economic communities pictured here: The East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD).
No full textAdapted from a map published in Ndomondo-Sigonda et al, 2020 [10] and modified and published here under the CC-BY 4.0 license.</p
AMRH initiative best practices report.
No full textIn the African Medicines Regulatory Harmonization initiative, national regulatory authorities (NRAs) within each of Africa’s regional economic communities coordinate their activities, rely on the work of one another and other trusted regulatory authorities, and apply other principles of smart regulation. The first regional medicines regulatory harmonization (MRH) initiative in Africa was launched in 2012, with the goal of accelerating access to quality, safe, effective medical products, and now five MRH initiatives are active on the continent. Thus, a wealth of knowledge regarding best practices and approaches to dealing with common challenges has accumulated. The goal of this qualitative study was to gather and share information on these best practices. To do this, we conducted interviews with key participants from four regional MRH initiatives—the East African Community (EAC), Southern African Development Community (SADC), Economic Community of West African States (ECOWAS), and Intergovernmental Authority on Development (IGAD)—as well as representatives from the pharmaceutical industry. Here we explore major themes that emerged from the interviews: 1. Transparency and reliability are critical; 2. Reliance is essential for smart regulation; 3. Multiple successful strategies for NRA capacity building have been identified; 4. Communication between heads of agencies is essential; 5. Cooperation at the regional level is not possible without leadership at the NRA level; 6. Sustainable funding remains challenging; and 7. Industry has important insights. We hope that the information on best practices shared in this article can benefit regional MRH initiatives inside and outside of Africa, ultimately helping them accelerate access to quality, safe, effective medical products.</div
ACTIVE INTERMEDIATES IN THE CHAIN OXIDATION OF DICHLOROSILANE
No full text D. Sameith, J.P. Monch, H.J. Tiller et al. Chem.Phys.Lett, 128, 483, (1986) V.V. Azatyan, A.S. Lukashev, S.S. Nagorny et al. Kinel Catal., 34, 404, (1993) V.P. Karpov, N.M. Rubtsov O.T. Ryzhkov et al. Chem.Phys.Reports, 17, 73, (1998)Author Institution: Russia, Institute for Structural Macrokinetics RAS, Moscow regionDichlorosilylenes have been detected in the branching chain reaction of the oxidation of dichlorosilane with for the first time. The emission spectra of rarified flame were recorded under static and flow conditions over the pressure range Torr and over the following intervals : in the range 220-280 nm in the range ; the continious emission caused by the blackbody radiation from the solid particles over 400nm. The intensive absorption in the range of 210-260 nm has been also observed under static conditions. The simultaneous recording of the mentioned intermediates as well as conductivity (revealed ) during the single ignition has been performed. The peaks of the signals are staggered in time. The first peak in time is (coincident with SiO), the second is the absorption peak, the third is the visible emission coincident with conductivity peak. 10\% additives (to fuel) of have a decreasing effect only on the absorption, visible emission and conductivity. It means that the absorbing intermediates contain Si-O bonds since has influence mainly on aerosol
AB INITIO STUDY OF THE ELECTRONIC SPECTRUM OF THE RADICAL
No full textA.G. Briggs ad R.G.W. Norrish, Proc. Roy. Soc. A278, 27 (1964). V.V. Azatyan {et al}., Dokl. Phys. Chem, 249, 1056 (1980).Author Institution: Group 325, Department of Chemistry, Nanjing University of Science and TechnologyThe equilibrium geometries, excitation energies force constant and vibrational frequencies for the low-lying electronic states X and of the radical have been calculated at the MRSDCI/DZ--P level. Our calculations indicate that the transition may correspond to the band system which lies between 275--314 mm in absorption spectrum of refs. [1.2]. Our calculated excitation energies for X AND , vibrational frequencies for the X and states and the geometry for the state are in agreement with available experimental data. The electronic transition dipale moments, oscillator strengths for the and transitions and radiative lifetimes for the and states are calculated based on the MRSDCI wavefunctions, predicting value of the radiative lifetime for the state also in reasonable agreement with experiment
Coming together to improve access to medicines: The genesis of the East African Community's Medicines Regulatory Harmonization initiative.
No full textHiiti Sillo and colleagues reveal how the East African Community's Medicines Regulatory Harmonization initiative improves access to important medicines in Africa
