Making items accessible for medicinal premature birth and procedures for their presentation

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Building up an African system on medicinal premature birth, Glenburn Lodge, South Africa, 11 - 13 March 2009 . The mission of Concept Foundation. To give access to items to sexualand conceptive soundness of guaranteed qualityto the general population part of lower and middleincome nations at the most reduced conceivable cost.Concept Foundation was built up as a global, magnanimous, not-for-profitorganization in

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Making items accessible for therapeutic fetus removal and procedures for their presentation Peter Hall Acting CEO Concept Foundation Bangkok, Thailand

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The mission of Concept Foundation To give access to items to sexual and regenerative strength of guaranteed quality to general society division of lower and center wage nations at the most minimal conceivable cost. Idea Foundation was built up as a universal, altruistic, not-revenue driven association in Thailand in 1989.

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What is Concept Foundation? To accomplish its central goal, Concept Foundation outlines and actualizes access-to-solutions projects to make quality item accessible at a reasonable cost. This includes : - the foundation and support of Public- Private Partnerships with pharmaceutical companies in creating nations; and - a methodical and composed way to deal with product presentation.

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What does a PPP need to accomplish? Private ventures need to create budgetary achievement Public division needs access to minimal effort medications of guaranteed quality High Margin Preferential Price How to adjust? ? Budgetary support from givers: Clinical research Technology exchange Quality confirmation Registration recording, and so forth. Money saving advantage to open division: Affordable open area valuing 4

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Conditions of understanding amongst WHO and Concept Foundation Price – Co-bundled item with special cost to open part, making it reasonable to numerous more ladies. Quality - Manufactured in USFDA/EMEA agreeable office, meeting global current Good Manufacturing Practice (cGMP). Administrative issues – Misoprostol utilized "off-name", administrative offices welcome formal enlistment of misoprostol for use in therapeutic premature birth; clinical piece of enrollment dossier in light of WHO clinical trials. Usability – co-bundled item less demanding for both supplier and lady.

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How does Concept Foundation accomplish it? Idea gives and oversees key parts to pharmaceutical assembling and showcasing, for example, innovation exchange, cGMP conventions, information from significant clinical reviews, GCP-agreeable clinical research, ICH-consistent administrative documentation, administrative dossier entries, and distinguishing nation based shippers and merchants. These exercises spare huge ventures for the business accomplice and accelerate time to advertise. Consequently, the business accomplice consents to serve immature and typically unrewarding markets with results of guaranteed quality at the least conceivable cost. Idea Foundation arranges a straightforward ex-manufacturing plant supply cost for open area organizations and guarantees that fitting methodologies have been created for the presentation of an item.

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What have Concept's PPPs accomplished? Somewhere in the range of 150 million vials of the once-a-month injectable prophylactic, Cyclofem, have given an extra decision to ladies in Asia and Latin America. Idea's portfolio has likewise incorporated a HIV analytic test and crisis contraception. As of now, Concept is making accessible a co-bundled mifepristone (1x200mg tablet) and misoprostol (4x200μg tablets) item, Medabon.

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Regulatory issues Regulatory documentation by and large contains 3 segments: clinical proof of security and viability - requires information from significant GCP-consistent clinical research, likewise a key necessity for makers of non specific medications is that they show that the items they create are bioequivalent to the first, trailblazer item. preclinical and toxicological proof of security; and information on chemicals, assembling and control (CMC). The CMC segment of an ICH-consistent administrative dossier is troublesome for some makers to meet. It requires full data on the Active Pharmaceutical Ingredients (APIs); the assembling procedure; and all quality affirmation techniques, incorporating consistence with cGMP.

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Regulatory issues Class 1:  ICH-consistent dossier. Full information from unique security and adequacy trials (NDA) or BE study (ANDA); full preclinical and toxicological information; full CMC information, prove meet cGMP and a DMF for API; GMP examination of plant South Africa Class 2:  Abbreviated dossier; no unique wellbeing information yet clinical survey condensing every single clinical dat and aftereffects of BE study; outline of preclinical/clinical information; BE study required; fabricating process approval; DMF for API Ethiopia, Algeria, Morocco, Tunisia, Egypt (may ask for extra information like Class 1 and producer site visit); The 14 nations of the South African Development Community (SADC) have formally embraced fit rules. In any case, it will be a few years before these nations meet comparative benchmarks to those required by South Africa.

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Regulatory issues 13 out of 14 SADC nations (fourteenth is South Africa), Angola, Botswana, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, Swaziland, Tanzania, Zambia and Zimbabwe are at different stages between classes 2 and 3; Ghana, Kenya and Uganda are additionally between classes 2 and 3. Class 3: Abbreviated dossier; diagram and rundown of preclinical/clinical information; no BE study; and no DMF required WAHO is endeavoring to blend prerequisites in 15 nations, Benin, Burkina Faso, Cape Verde, Côte d'Ivoire, The Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone, and Togo however is a great deal encourage behind. Ghana is the uttermost ahead. Class 4:  No formal administrative dossier required. The rest of the 19 African nations fall under Class 3 and a couple of under Class 4.

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Objectives of an initial system Provision of therapeutic fetus removal with regards to CAC in all offices meeting the prerequisites of the national rules. In the underlying stage this will be embraced in chosen human services offices. Improvement of a preparation educational modules for the arrangement of far reaching premature birth mind, specifically of MVA and medicinal fetus removal and including values illumination. Advancement of IEC materials for experts and clients. Advancement of a backing technique for CAC. Usage of operations research to permit getting ready for scaling up to other medicinal services offices.

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What has happened to date? Presentation of medicinal fetus removal into the general population division has experienced either: exercises being attempted by different national and worldwide associations in a specially appointed and ungraceful way; or by undertaking a clinical trial or little OR study in lieu of an organized early on procedure – neither tending to key administration conveyance needs nor ensuring the accessibility or moderateness of item.

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An ideal way to deal with item prologue To accomplish the expressed goals, it is important to create and actualize a suitably planned early on process. This requires: a deliberate and incremental approach; and coordination and cooperation between the public wellbeing framework and every single key partner - synchronization of exercises is the way to building a proper and strong wellbeing system for the arrangement of medicinal fetus removal. This has started in Nepal.

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What is a strong wellbeing framework? Drugs for therapeutic premature birth can be given via prepared mid-level suppliers at the same time, in the few instances of deficient fetus removal or over the top seeping, there is requirement for access to referral administrations. The wellbeing framework must guarantee access to a supplier prepared in the utilization of manual vacuum desire (MVA) and to blood transfusion administrations. The wellbeing framework must be set up to give preparing of all levels of medicinal services suppliers and qualities illumination with suppliers. Premature birth remains a delicate issue in numerous nations and there is a proceeding with requirement for support with suppliers and in addition the more extensive society.

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Nepal Advocacy FHD/MOH TCIC/Ipas NESOG TCIC/Ipas NHTC/DHS Training educational programs advancement Policy FHD/MOH MSI FPAN PSI CREHPA NESOG Nursing Council Medical Council TCIC/Ipas Material improvement NHIECC TCIC/Ipas Service conveyance Regional/region wellbeing experts Project administration TCIC NESOG Nursing Council Medical Council PSI All recorded CAC specialist organizations Public & private Training Operations Research NHTC/DHS CREHPA Product accessibility Sun Pharma NESOG Ipas accomplices Concept

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Evidence now indicates 24 hours is satisfactory Day 1 Day 2 Day 3 0800 2000 0800 2000 0800 24h 48h Evidence from WHO examines demonstrate the viability of the mifepristone-misoprostol regimen to be comparative for interims from 24-48 hours post-mifepristone, when misoprostol is given vaginally. Comparative with sublingual organization.

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The requirement for data - suppliers/arrangement producers WHO sorted out a meeting of experienced scientists and clinicians taking a shot at medicinal fetus removal. They reacted to a rundown of the most every now and again made inquiries about medicinal premature birth from social insurance staff giving fetus removal administrations. They investigated those inquiries and accumulated answers in view of logical writing and their own understanding. Oftentimes got some information about medicinal premature birth. World Health Organization, Geneva 2006 www.who.int/regenerative wellbeing/productions/medical_abortion/index.html

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The requirement for data PATH, Ipas, Concept and WHO/HRP are concluding materials for medicinal services suppliers and program chiefs who are attempting to present Medabon®. They are additionally proposed to achieve arrangement producers and the media and include: Medical Abortion & Medabon®: Key Talking Points Medabon®: Frequently Asked Questions (FAQ) Medabon®: What You Need to Know (test understanding pamphlet) Medabon®: Medical & Service Delivery Guidelines Medabon®: Background for Providers of Emergency Care Medabon®: A Framework for

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