- [[Joseph Opare]]: we're privileged to be part of this consortium. We continue to have this infection. We've treated this condition for more than 15 years. Multifaceted approach. Happy to be part of this consortium.
- [[Joseph Opare]]: we're privileged to be part of this consortium. We continue to have this infection. We've treated this condition for more than 15 years. Multifaceted approach. Happy to be part of this consortium.
- PPB: She's not a director. The previous speakers have spoken. I have the written speach from the director. National drug regulatory authority. We're involved in RCT were we try to get the input of the scientists. One of our mandates is to have products with quality, efficacious and safe. When it is needed, it has to be available. When a product is licensed by the PPB. Ghana people, we privileged to have you. We're in touch with the Ghana FDA, we have counterparts. We can consult with them. For a long time alb and mlb. The need for repeated dosing. The one health guideline development group recomended further research in alternative antihelminthic medication or combination to avoid resistance development. The prooposed fdc of alb/ivm represents a promising advancement for those ailed by this disease. the ppb is commited to: 1: ensure that all mediciens approved meet the highest standards of safety, efficacy and quality. we'll evaluate the fdc to ensure that it meets those standards. 2) We appreciate your RCT your expertise we pledge to mantain transparency in this process keeping all stakeholders engaged. postmarket surveillance to ensure ongoing safety and efficacy. I reiterate the board commitment to improve public health through the approval and disemination of safe and effective medicines. we can improve the lifes of millions in kenya and globally. we're particularly optimistic about this initiative.
- PPB: She's not a director. The previous speakers have spoken. I have the written speach from the director. National drug regulatory authority. We're involved in RCT were we try to get the input of the scientists. One of our mandates is to have products with quality, efficacious and safe. When it is needed, it has to be available. When a product is licensed by the PPB. Ghana people, we privileged to have you. We're in touch with the Ghana FDA, we have counterparts. We can consult with them. For a long time alb and mlb. The need for repeated dosing. The one health guideline development group recomended further research in alternative antihelminthic medication or combination to avoid resistance development. The prooposed fdc of alb/ivm represents a promising advancement for those ailed by this disease. the ppb is commited to: 1: ensure that all mediciens approved meet the highest standards of safety, efficacy and quality. we'll evaluate the fdc to ensure that it meets those standards. 2) We appreciate your RCT your expertise we pledge to mantain transparency in this process keeping all stakeholders engaged. postmarket surveillance to ensure ongoing safety and efficacy. I reiterate the board commitment to improve public health through the approval and disemination of safe and effective medicines. we can improve the lifes of millions in kenya and globally. we're particularly optimistic about this initiative.
- [[Doris Njomo]]: ESACIPAC has been conducting research about the program for STH. Mantain an evidence based approach. There has been a significar reduction at baseline STH. we're approaching the <2%.Howeverthisreductionisonlytolos3.DuetotheresistanceofStrongyandTrichuris.Theydon'trespondeffectivelytoalb.ItcanbeagamechangerandapromisinginterventionfortheWHOgoals.Westillhavealotofworktodo.ButtreatmentofSACistheentrypoint.AlsorepresentthedirectorgeneralofKEMRI.I'mgoingtoread.Theresultsofthisprojectareequallybeingawaited.notonlyinkenyabutmanycountriesburdened.speciallyforSAC.KEMRIsupport.
- [[Doris Njomo]]: ESACIPAC has been conducting research about the program for STH. Mantain an evidence based approach. There has been a significar reduction at baseline STH. we're approaching the <2%.Howeverthisreductionisonlytolos3.DuetotheresistanceofStrongyandTrichuris.Theydon'trespondeffectivelytoalb.ItcanbeagamechangerandapromisinginterventionfortheWHOgoals.Westillhavealotofworktodo.ButtreatmentofSACistheentrypoint.AlsorepresentthedirectorgeneralofKEMRI.I'mgoingtoread.Theresultsofthisprojectareequallybeingawaited.notonlyinkenyabutmanycountriesburdened.speciallyforSAC.KEMRIsupport.
- [[Julie Jacobson]] and [[Alan Brooks]]: We need to make sure that we can anticipate and answer the questions to make this a public health intervention. Encourage everyone to think outside your area of work. Flipboard. Go anytime you want to. Idea to contribute, question to ask. Connections to drive to success. What a rewarding opening session. We're working towards healthier childern, women and their babies. How do we get there? Its born on science, on strong and rigorous sciece and now how do we make it available. What is the importance of the FDC. Its an answer to a call. The current drugs didn't have the full coverage. Clinics and MDA distribuuytion. It keeps distribution simple. If we make this complicated it wont be easily accepted. The largest risk of MDA is chocking. Its orodispersible. mango flavoured. Integration. 2 drugs that treat multiple NTDs. anticipate risk of resistance. What evidence is needed for WHO and countries to say: yes, we're introducing it. One regimen for children and one for adults. What's the policy pathway through WHO. There has already been a Phase II/III, REALISE trial for safety. The target is a prequalified product. Shelf life is around 2 years, doesn't need any special conditions. Who is going to make it? Will the supply be available? THey have the capacity to do this. They're producing many drugs at scale around the world. This wont be a donated product. We're not on the position to create another donated product. keep it as affordable as possible and funding oportunities. Where do we come: the fdc is a new product and an old approach. alb/ivm have been used frequently for LF. In our conversations with WHO about how to better give them the info is a WHO Policy Brief and it looks like the best pathway. rigorous
- [[Julie Jacobson]] and [[Alan Brooks]]: We need to make sure that we can anticipate and answer the questions to make this a public health intervention. Encourage everyone to think outside your area of work. Flipboard. Go anytime you want to. Idea to contribute, question to ask. Connections to drive to success. What a rewarding opening session. We're working towards healthier childern, women and their babies. How do we get there? Its born on science, on strong and rigorous sciece and now how do we make it available. What is the importance of the FDC. Its an answer to a call. The current drugs didn't have the full coverage. Clinics and MDA distribuuytion. It keeps distribution simple. If we make this complicated it wont be easily accepted. The largest risk of MDA is chocking. Its orodispersible. mango flavoured. Integration. 2 drugs that treat multiple NTDs. anticipate risk of resistance. What evidence is needed for WHO and countries to say: yes, we're introducing it. One regimen for children and one for adults. What's the policy pathway through WHO. There has already been a Phase II/III, REALISE trial for safety. The target is a prequalified product. Shelf life is around 2 years, doesn't need any special conditions. Who is going to make it? Will the supply be available? THey have the capacity to do this. They're producing many drugs at scale around the world. This wont be a donated product. We're not on the position to create another donated product. keep it as affordable as possible and funding oportunities. Where do we come: the fdc is a new product and an old approach. alb/ivm have been used frequently for LF. In our conversations with WHO about how to better give them the info is a WHO Policy Brief and it looks like the best pathway. rigorous
- [[Ale]]: Will the Policy Brief include the recomendation of the FDC?
FMS
7 months ago