Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Peter Jones and discussed the OIE/GALVmed Focal Training in South Africa during November 2010. It discusses the feedback, recommendations and conclusions from this training.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
This document provides information about the jurisdiction and locations of various Patent Offices in India.
It lists the addresses and contact details of 5 Patent Offices located in different regions - Delhi, Mumbai, Chennai, Kolkata, and the Head Office in Kolkata. It details the territorial jurisdictions of each office covering different states and union territories.
All applications, notices and documents related to patents must be filed to the appropriate office depending on the jurisdiction. It also provides information on payment of fees for patent filings.
Este documento resume la historia de la tipografía desde sus orígenes hasta el siglo XX. Comienza explicando el desarrollo del alfabeto desde los primeros pictogramas sumerios hasta la escritura cuneiforme. Luego describe la invención de la imprenta por Johannes Gutenberg en el siglo XV y los grandes tipógrafos que surgieron en los siglos posteriores como Garamond y Granjean. Finalmente, resume brevemente los principales estilos tipográficos desde la transición hasta principios del siglo XX.
PRUEBAS METODOLOGIA DE LA INVESTIGACIONandy2010avbh
Este documento presenta un examen sobre conceptos estadísticos relacionados con la metodología de la investigación. El examen contiene preguntas de selección múltiple sobre el uso correcto de pruebas estadísticas como la prueba de Chi cuadrado y la prueba t de Student, así como conceptos como los niveles de significación, los errores tipo I y II, y el rechazo de hipótesis nulas. También incluye ejercicios para relacionar diferentes pruebas estadísticas y conceptos.
The document provides an executive profile and work experience summary for Edward A. Migut, a senior marketing and product management leader. It highlights his expertise in strategic business planning, product management, brand management, marketing programs, and new business development. It lists his work experience spanning over 20 years in marketing and product management roles for various technology companies, where he successfully drove revenue growth through new product launches and marketing initiatives.
Lori Babigian demonstrates her unique capability to reposition legacy technology companies for growth in challenging business environments with expert execution of new marketing automation technologies to support innovative new product introductions.
This document provides information about the jurisdiction and locations of various Patent Offices in India.
It lists the addresses and contact details of 5 Patent Offices located in different regions - Delhi, Mumbai, Chennai, Kolkata, and the Head Office in Kolkata. It details the territorial jurisdictions of each office covering different states and union territories.
All applications, notices and documents related to patents must be filed to the appropriate office depending on the jurisdiction. It also provides information on payment of fees for patent filings.
Este documento resume la historia de la tipografía desde sus orígenes hasta el siglo XX. Comienza explicando el desarrollo del alfabeto desde los primeros pictogramas sumerios hasta la escritura cuneiforme. Luego describe la invención de la imprenta por Johannes Gutenberg en el siglo XV y los grandes tipógrafos que surgieron en los siglos posteriores como Garamond y Granjean. Finalmente, resume brevemente los principales estilos tipográficos desde la transición hasta principios del siglo XX.
PRUEBAS METODOLOGIA DE LA INVESTIGACIONandy2010avbh
Este documento presenta un examen sobre conceptos estadísticos relacionados con la metodología de la investigación. El examen contiene preguntas de selección múltiple sobre el uso correcto de pruebas estadísticas como la prueba de Chi cuadrado y la prueba t de Student, así como conceptos como los niveles de significación, los errores tipo I y II, y el rechazo de hipótesis nulas. También incluye ejercicios para relacionar diferentes pruebas estadísticas y conceptos.
The document provides an executive profile and work experience summary for Edward A. Migut, a senior marketing and product management leader. It highlights his expertise in strategic business planning, product management, brand management, marketing programs, and new business development. It lists his work experience spanning over 20 years in marketing and product management roles for various technology companies, where he successfully drove revenue growth through new product launches and marketing initiatives.
Lori Babigian demonstrates her unique capability to reposition legacy technology companies for growth in challenging business environments with expert execution of new marketing automation technologies to support innovative new product introductions.
This hotel offers amenities such as a complimentary breakfast, free WiFi, a fitness center and pool for guests as well as meeting space up to 912 square feet, catering services, and business services like printing for professional needs. The property has recently renovated all rooms with new furniture and décor while maintaining quality. It is located in Yuba City, California and can be reached at the provided phone number or website for more information.
Professor John Bennett wrote a letter of recommendation for Jimmy Michaels, who was an exemplary student in two of Bennett's marketing classes. Bennett describes Jimmy as a hard worker who readily accepts challenges and contributes insightful comments during class discussions. Jimmy's performance placed him in the top 10% of both classes. Bennett also notes that Jimmy is thoughtful, kind, and an effective team player, as shown by the positive peer evaluations he received on group projects.
Nafnaþulur (“Conhecimento de Nomes”) é uma listagem poética de várias categorias sobre
os Deuses,os Jötnar,as Fêmeas Trolls e outros seres.Essa obra foi preservada na Edda em
Prosa de Snorri Sturlusson.
La Unión Europea ha acordado un embargo petrolero contra Rusia en respuesta a la invasión de Ucrania. El embargo prohibirá las importaciones marítimas de petróleo ruso a la UE y pondrá fin a las entregas a través de oleoductos dentro de seis meses. Esta medida forma parte de un sexto paquete de sanciones de la UE destinadas a aumentar la presión económica sobre Moscú y privar al Kremlin de fondos para financiar su guerra.
Aktuální verze katalogu pro nový Citroën C4 CACTUS. Více informací o vozu, aktuální ceny, fotografie a videa na http://citroen.carling.cz/citroen-c4-cactus
Este documento describe factores que modifican el riesgo cardiovascular (RCV), aumentándolo o disminuyéndolo. Factores que aumentan el RCV incluyen personas socialmente desvalidas, sedentarias u obesas, con diabetes, dislipidemia, hiperhomocisteinemia, o antecedentes familiares de enfermedad cardiovascular prematura. Factores que disminuyen el RCV son niveles altos de colesterol HDL o antecedentes familiares de longevidad. El documento también clasifica el riesgo cardiovascular como muy alto, alto, moder
El documento informa sobre el Día Mundial de las Víctimas de Tránsito, que se conmemora el tercer domingo de noviembre. Según la OMS, los accidentes de tránsito son una de las principales causas de muerte a nivel mundial, acabando con la vida de casi 1,3 millones de personas cada año. En la ciudad se realizó una caminata en conmemoración de este día. El orden del día del Concejo Deliberante incluye proyectos de ordenanza y despachos de comisión.
Registro de personas diagnosticadas de tea.José María
El registro nacional de personas diagnosticadas de TEA es un instrumento importante para unificar criterios de calidad asistencial, buscar factores de riesgo de los TEA y promover la mejora de los tratamientos.
Guía de pokémon negro 2 y pokémon blanco 2 Pato Cuervo
El documento presenta una guía detallada de los eventos y personajes de los videojuegos Pokémon Negro 2 y Blanco 2. Comienza con la elección del personaje y Pokémon inicial, y continúa describiendo las ciudades, rutas, gimnasios y batallas que se enfrentarán durante la aventura. Incluye información sobre los Pokémon salvajes y entrenadores que se pueden encontrar en cada área del juego.
La formación del profesorado consiste en la preparación y actualización continua de los docentes a través de una reflexión crítica sobre su práctica y el intercambio de experiencias con otros profesores. Las instituciones se han encargado de crear programas de formación permanente para los educadores mediante departamentos universitarios especializados y asociaciones profesionales. Sin embargo, las políticas de profesionalización del magisterio no han tenido todo el impacto esperado debido a los intereses contrapuestos en el sistema educativo.
Este documento presenta un curso básico sobre extinción de incendios. Explica conceptos clave como el triángulo y tetraedro del fuego, los mecanismos de extinción, y la clasificación de los fuegos en tipos A, B, C, D y E dependiendo del estado físico del combustible. También cubre temas como agentes extintores, extintores, bocas de incendio y columnas hidrantes.
Caso Clínico de Paciente Joven con Histoplasmosis cerebral sin aparente vía de entrada primaria, con datos de riesgo y enfermedad concomitante e inmunocomprimiso
Conoce como poder dar renombre a tu empresa mediante la certificación MoProSoft, apoyado por el gobierno mexicano, y de esta manera mejorar en la creación y mantenimiento del software
Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Gilly Cowan and discussed GALVmed's progress in following up the recommendations from the 2010 Global Animal Health Conference when African regulators asked for a harmonised registration system, mutual recognition and training for their regulators in the registration of veterinary vaccines.
GALVmed, the Global Alliance for Livestock Veterinary Medicines, works through its partners to protect livestock and improve human lives by making livestock vaccines, diagnostics & medicines accessible and affordable to the millions of those who rely on livestock.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
To read more highlights from the conference, click here: https://twitter.com/hashtag/GAHC2015?src=hash
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
Webinar on safety tips for in-person researchUXalliance
Remote UX research is great, but the world is opening up again, so UX agencies globally are restarting face-to-face research. This webinar is a chance to hear directly from those involved.
This hotel offers amenities such as a complimentary breakfast, free WiFi, a fitness center and pool for guests as well as meeting space up to 912 square feet, catering services, and business services like printing for professional needs. The property has recently renovated all rooms with new furniture and décor while maintaining quality. It is located in Yuba City, California and can be reached at the provided phone number or website for more information.
Professor John Bennett wrote a letter of recommendation for Jimmy Michaels, who was an exemplary student in two of Bennett's marketing classes. Bennett describes Jimmy as a hard worker who readily accepts challenges and contributes insightful comments during class discussions. Jimmy's performance placed him in the top 10% of both classes. Bennett also notes that Jimmy is thoughtful, kind, and an effective team player, as shown by the positive peer evaluations he received on group projects.
Nafnaþulur (“Conhecimento de Nomes”) é uma listagem poética de várias categorias sobre
os Deuses,os Jötnar,as Fêmeas Trolls e outros seres.Essa obra foi preservada na Edda em
Prosa de Snorri Sturlusson.
La Unión Europea ha acordado un embargo petrolero contra Rusia en respuesta a la invasión de Ucrania. El embargo prohibirá las importaciones marítimas de petróleo ruso a la UE y pondrá fin a las entregas a través de oleoductos dentro de seis meses. Esta medida forma parte de un sexto paquete de sanciones de la UE destinadas a aumentar la presión económica sobre Moscú y privar al Kremlin de fondos para financiar su guerra.
Aktuální verze katalogu pro nový Citroën C4 CACTUS. Více informací o vozu, aktuální ceny, fotografie a videa na http://citroen.carling.cz/citroen-c4-cactus
Este documento describe factores que modifican el riesgo cardiovascular (RCV), aumentándolo o disminuyéndolo. Factores que aumentan el RCV incluyen personas socialmente desvalidas, sedentarias u obesas, con diabetes, dislipidemia, hiperhomocisteinemia, o antecedentes familiares de enfermedad cardiovascular prematura. Factores que disminuyen el RCV son niveles altos de colesterol HDL o antecedentes familiares de longevidad. El documento también clasifica el riesgo cardiovascular como muy alto, alto, moder
El documento informa sobre el Día Mundial de las Víctimas de Tránsito, que se conmemora el tercer domingo de noviembre. Según la OMS, los accidentes de tránsito son una de las principales causas de muerte a nivel mundial, acabando con la vida de casi 1,3 millones de personas cada año. En la ciudad se realizó una caminata en conmemoración de este día. El orden del día del Concejo Deliberante incluye proyectos de ordenanza y despachos de comisión.
Registro de personas diagnosticadas de tea.José María
El registro nacional de personas diagnosticadas de TEA es un instrumento importante para unificar criterios de calidad asistencial, buscar factores de riesgo de los TEA y promover la mejora de los tratamientos.
Guía de pokémon negro 2 y pokémon blanco 2 Pato Cuervo
El documento presenta una guía detallada de los eventos y personajes de los videojuegos Pokémon Negro 2 y Blanco 2. Comienza con la elección del personaje y Pokémon inicial, y continúa describiendo las ciudades, rutas, gimnasios y batallas que se enfrentarán durante la aventura. Incluye información sobre los Pokémon salvajes y entrenadores que se pueden encontrar en cada área del juego.
La formación del profesorado consiste en la preparación y actualización continua de los docentes a través de una reflexión crítica sobre su práctica y el intercambio de experiencias con otros profesores. Las instituciones se han encargado de crear programas de formación permanente para los educadores mediante departamentos universitarios especializados y asociaciones profesionales. Sin embargo, las políticas de profesionalización del magisterio no han tenido todo el impacto esperado debido a los intereses contrapuestos en el sistema educativo.
Este documento presenta un curso básico sobre extinción de incendios. Explica conceptos clave como el triángulo y tetraedro del fuego, los mecanismos de extinción, y la clasificación de los fuegos en tipos A, B, C, D y E dependiendo del estado físico del combustible. También cubre temas como agentes extintores, extintores, bocas de incendio y columnas hidrantes.
Caso Clínico de Paciente Joven con Histoplasmosis cerebral sin aparente vía de entrada primaria, con datos de riesgo y enfermedad concomitante e inmunocomprimiso
Conoce como poder dar renombre a tu empresa mediante la certificación MoProSoft, apoyado por el gobierno mexicano, y de esta manera mejorar en la creación y mantenimiento del software
Presented at the 4th Global Animal Health Conference 2015 #GAHC2015 on Regulatory Convergence. Held in Dar Es Salaam, Tanzania, 24-25 June 2015.
This was presented by GALVmed consultant Gilly Cowan and discussed GALVmed's progress in following up the recommendations from the 2010 Global Animal Health Conference when African regulators asked for a harmonised registration system, mutual recognition and training for their regulators in the registration of veterinary vaccines.
GALVmed, the Global Alliance for Livestock Veterinary Medicines, works through its partners to protect livestock and improve human lives by making livestock vaccines, diagnostics & medicines accessible and affordable to the millions of those who rely on livestock.
For more information on this conference, hosted by Health For Animals (formerly IFAH), visit here: http://healthforanimals.org/global-animal-health-conference-addresses-regulatory-barriers/
To read more highlights from the conference, click here: https://twitter.com/hashtag/GAHC2015?src=hash
TGA webinar: The Good Manufacturing Practice (GMP) Clearance Framework – an o...TGA Australia
The document provides an overview of Australia's Good Manufacturing Practice (GMP) Clearance Framework. It discusses the legislative basis for manufacturing requirements, the roles and activities of the Manufacturing Quality Branch, and the two pathways for obtaining a GMP Clearance - a desk-based assessment through a Mutual Recognition Agreement or Compliance Verification, or an on-site TGA inspection. It also outlines the history of GMP Clearance, recognized authorities through agreements like MRAs, and the MRA assessment pathway.
Webinar on safety tips for in-person researchUXalliance
Remote UX research is great, but the world is opening up again, so UX agencies globally are restarting face-to-face research. This webinar is a chance to hear directly from those involved.
"Hi All - Please find attached all the details regarding the ILF Chronic Oedema Outcome Measure project.
The link is now live. Can you please complete and send out to all your contacts in Industry as well as HCPs. We really need a good UK representation. You can send it Internationally too. If you do have email mail shots or use social media please can you mention it,
Many thanks for your help
https://www.surveymonkey.com/r/CYSCKKT
Kind Regards
Melanie J Thomas
National Clinical Lead for Lymphoedema in Wales
Cimla Health and Social Care Centre
This document discusses the responsibilities of Marketing Authorization Holders (MAHs) in Japan. It explains that MAHs must have a suitable quality control system called Good Quality Practice (GQP) and a suitable safety control system after manufacturing called Good Vigilance Practice (GVP). The GQP ensures quality assurance of medical devices, while the GVP standardizes the practice for safety control, such as collecting and evaluating safety information. The document also provides an overview of the GQP organization structure and reporting requirements under GVP.
Official Representative of the International Research ofthe Mission for European and International Relation and Cooperation (MREIC) ofthe French National Health Insurance Fund (CNAMTS)
Presentation: Global pharmacovigilance networks - A regulator'sTGA Australia
Global pharmaceutical companies manufacture and distribute a broad portfolio of drug products in multiples regions and countries. The pharmacovigilance system must ensure safety data collection in compliance with local regulations, and consolidate all sources to ensure an ongoing monitoring of potential changes in benefit-risk profiles. It must also guarantee a timely communication to patients, prescribers and regulatory authorities. The complexity resides in the need for a dense network of local safety departments, a strong global organisation processing and analysing cases, and a reporting system ensuring compliance to heterogeneous regulatory requirements. Pfizer has one of the largest pharmacovigilance department among all global companies, and has established patient safety as a core priority. We will describe how pharmacovigilance is organised at Pfizer, global compliance and individual patient safety.
Regulatory aspect of pharamacutical packgingvineet gupta
There is no doubt that the regulatory climate is getting more restrictive for pharmaceutical products and it is likely that packaging for pharmaceuticals will have more and more constraints placed upon it.
This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx
This document discusses regulatory and practical considerations for investigational medicinal products (IMPs) used in clinical trials. It covers EU and UK regulations related to IMPs, common challenges across the clinical trial lifecycle including patient factors, labels, expiry dates and stability. Technical agreements, CTAs, VAT exemptions, and an overview of a clinical supply project are also summarized.
The document discusses the International Conference on Harmonization (ICH). ICH was established in 1990 to harmonize technical requirements for pharmaceutical registration among countries in Europe, Japan and the United States. It aims to ensure safety, quality and efficacy of drugs while avoiding duplication of testing. Key ICH guidelines cover quality, safety, efficacy and multidisciplinary topics. Stability testing guidelines require evaluating drug products under different storage conditions and timepoints to determine shelf life. The harmonization process has led to over 50 guidelines streamlining pharmaceutical research and development globally.
REVIEW OF RESOLAB FMD SUBNETWORK ACTIVITIESExternalEvents
This document summarizes the activities of the RESOLAB FMD subnetwork from 2010-2012. Key points:
- The subnetwork collated FMD outbreak and diagnostic data from member countries, finding outbreaks of serotypes O, A, SAT1 and SAT2 reported. Diagnostic capacity for FMD was lacking in most member lab countries.
- A 2012 training in FMD diagnosis sponsored by EUFMD and FAO helped build capacity, with kits and primers distributed. However, control strategies for FMD are still lacking in most countries.
- Moving forward, the subnetwork aims to further strengthen diagnostic capacity, characterize circulating strains, improve reporting to advance control along PCP guidelines, and conduct
This document summarizes research on how UK firms make export decisions. It finds that:
- Customer demand plays a key role in firms' exporting decisions at various stages, though its importance may change over time.
- Exporting decisions are not static - firms change how and why they export as they persist, and new/intermittent exporters may do the same if they continue exporting.
- Multiple internal and external stakeholders, like business connections, influence export decision-making. Support targeted at different firms' export stages could encourage more exporting.
Similar to OIE/GALVmed Focal Training, South Africa 2010: Feedback, Recommendations and Conclusions (20)
Indira awas yojana housing scheme renamed as PMAYnarinav14
Indira Awas Yojana (IAY) played a significant role in addressing rural housing needs in India. It emerged as a comprehensive program for affordable housing solutions in rural areas, predating the government’s broader focus on mass housing initiatives.
Presentation by Rebecca Sachs and Joshua Varcie, analysts in CBO’s Health Analysis Division, at the 13th Annual Conference of the American Society of Health Economists.
This report explores the significance of border towns and spaces for strengthening responses to young people on the move. In particular it explores the linkages of young people to local service centres with the aim of further developing service, protection, and support strategies for migrant children in border areas across the region. The report is based on a small-scale fieldwork study in the border towns of Chipata and Katete in Zambia conducted in July 2023. Border towns and spaces provide a rich source of information about issues related to the informal or irregular movement of young people across borders, including smuggling and trafficking. They can help build a picture of the nature and scope of the type of movement young migrants undertake and also the forms of protection available to them. Border towns and spaces also provide a lens through which we can better understand the vulnerabilities of young people on the move and, critically, the strategies they use to navigate challenges and access support.
The findings in this report highlight some of the key factors shaping the experiences and vulnerabilities of young people on the move – particularly their proximity to border spaces and how this affects the risks that they face. The report describes strategies that young people on the move employ to remain below the radar of visibility to state and non-state actors due to fear of arrest, detention, and deportation while also trying to keep themselves safe and access support in border towns. These strategies of (in)visibility provide a way to protect themselves yet at the same time also heighten some of the risks young people face as their vulnerabilities are not always recognised by those who could offer support.
In this report we show that the realities and challenges of life and migration in this region and in Zambia need to be better understood for support to be strengthened and tuned to meet the specific needs of young people on the move. This includes understanding the role of state and non-state stakeholders, the impact of laws and policies and, critically, the experiences of the young people themselves. We provide recommendations for immediate action, recommendations for programming to support young people on the move in the two towns that would reduce risk for young people in this area, and recommendations for longer term policy advocacy.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
https://www.youtube.com/@jenniferschaus/videos
Presentation by Julie Topoleski, CBO’s Director of Labor, Income Security, and Long-Term Analysis, at the 16th Annual Meeting of the OECD Working Party of Parliamentary Budget Officials and Independent Fiscal Institutions.
Contributi dei parlamentari del PD - Contributi L. 3/2019Partito democratico
DI SEGUITO SONO PUBBLICATI, AI SENSI DELL'ART. 11 DELLA LEGGE N. 3/2019, GLI IMPORTI RICEVUTI DALL'ENTRATA IN VIGORE DELLA SUDDETTA NORMA (31/01/2019) E FINO AL MESE SOLARE ANTECEDENTE QUELLO DELLA PUBBLICAZIONE SUL PRESENTE SITO
Bharat Mata - History of Indian culture.pdfBharat Mata
Bharat Mata Channel is an initiative towards keeping the culture of this country alive. Our effort is to spread the knowledge of Indian history, culture, religion and Vedas to the masses.
AHMR is an interdisciplinary peer-reviewed online journal created to encourage and facilitate the study of all aspects (socio-economic, political, legislative and developmental) of Human Mobility in Africa. Through the publication of original research, policy discussions and evidence research papers AHMR provides a comprehensive forum devoted exclusively to the analysis of contemporaneous trends, migration patterns and some of the most important migration-related issues.
OIE/GALVmed Focal Training, South Africa 2010: Feedback, Recommendations and Conclusions
1. Peter Jones - Consultant to GALVmed
4th Global Animal Health Conference 2015
Regulatory Convergence.
Dar Es Salaam – Tanzania. June 24 -25, 2015
OIE/GALVmed Focal Training, South Africa 2010:
Feedback, Recommendations and Conclusions
3. We’ve come a long way!
Paragraph or heading text
Bullet point 1
• Bullet point 2
• Bullet point 3
• Bullet point 4
Paragraph or heading text
Bullet point 1
• Bullet point 2
• Bullet point 3
• Bullet point 4
Slide 2
4. Dr Baptiste Dungu
Senior Director: R&D
Staff workshop
November 2009
GALVmed workshop:
Future of harmonisation for
vaccine registration
24th November 2010Dr Baptiste Dungu
Senior Director R&D
5. Regulatory issues: what are we trying to achieve:
•Strong relation established with key Global players on
product regulation: VICH, OIE, IFAH
•A questionnaire to best define the current status of
vaccine regulation in Africa hast been sent on behalf of
PANVAC and GALVmed to 49 countries.
•GALVmed helped with sponsorship of the OIE Focal
Group Training in South Africa – Workshop on future of
harmonisation for vaccine registration
•Future activities will depend on outcome of this
workshop.
Simplify, improve, coordinate vaccine regulatory issues in Africa
1 Baseline current situation
2 Proposal for a way forward with involvement of local stakeholders
6. Objectives of the Workshop
1) Analysis of the Questionnaire:
o Identify key gaps
2) Support the establishment of forums of Regulatory
authorities (in conjunction with PANVAC & OIE):
o Initiate regional forums (already existing in some regions)
o Create a continental forum
3) Work toward harmonization:
o Explore possibilities of mutual recognition at sub-regional level,
then continental level
o Develop a 5 year strategy and plan
7. Questionnaires to 49 countries: Respondents-35
Slide 6
COUNTRY Region COUNTRY Region
1 Algeria N 15 Burundi E
2 Egypt N 16 Comoros E
3 Morocco N 17 Djibouti E
4 Tunisia N 18 Kenya E
5 Cameroon C 19 Rwanda E
6 Congo - Brazzavile C 20 Seychelles E
7 Burkina Faso W 21 Sudan E
8 Cote D'Ivoire W 22 Tanzania E
9 Ghana W 23 Uganda E
10 Mali W 24 Angola S
11 Mauritania W 25 Botswana S
12 Nigeria W 26 Dem Rep Congo S
13 Senegal W 27 Lesotho S
14 Togo W 28 Madagascar S
29 Malawi S
30 Mozambique S
31 Namibia S
32 South Africa S
33 Swaziland S
34 Zambia S
35 Zimbabwe S
North: 4
Central:2
West:8
East: 9
Southern 12
8. The Questionnaire
Seven main sections:
Section 1. – Scope of the Regulatory system in your country
Section 2. - The Marketing Authorisation
Section 3. – Process for the Regulatory Procedure
Section 4. – Manufacture and Imports
Section 5. – Supervision and Sanctions
Section 6. – Labeling
Section 7. – General Provisions
Slide 7
9. Conclusions from Section 1:Scope of the Regulatory
System in your country
•Just over half of countries authorize veterinary vaccines independently of human
ones: they have separate agencies - NB!
•Over 70% of countries assign the authorization of veterinary vaccines to the
Ministry of Agriculture
•Most authorities have joint responsibility for vaccines and veterinary
pharmaceuticals
•By far the greatest majority of countries require authorization prior to marketing and
there are very few exceptions e.g. special import/crisis management: Same applies
even if vaccine is manufactured in the country itself
•If no vaccine authorized for a particular indication, then possible in over 2/3 of
countries to use vaccine authorized elsewhere in Africa; in just over half for vaccines
authorized outside.
Slide 8
10. Conclusions from Section 2: The marketing authorization
•Just over ½ countries require applicants to be established as a business before
accepting applications (or agents/distributors)
•Greatest majority of applicants have to be established in own country to
manufacture vaccines (other 16% is of concern)
•Only half the countries require vaccines to be authorized in another African country
whereas 2/3 require authorization outside Africa
•Some countries undertake full assessment despite assurances that vaccine are
fully licensed elsewhere outside Africa
•Only 1/3 of respondents recognize the assessment and accept authorization of
another African country (“MRP”?). Some confusion in that one respondent says that
discussion within SADC is ongoing, it is not acknowledged by the others
•About 1/3 (same as above) take the assessments and authorization of countries
outside Africa; mainly UK, France and EU (centralized) and endorsements by OIE
and Panvac
Slide 9
11. Conclusions from Section 2: The marketing authorization
- continued
•Only centralized initiative is l’UEMOA
•Data requirements for applicants to file for authorization are very consistent
throughout, with little if any derogations ( generally all asking for the same thing)
•Data protection is very limited/variable and a likely disincentive to many R&D
companies
•Independent expert reports are required by mostly all countries
Slide 10
12. Conclusions from Section 3: Process for the regulatory
procedure
•Application procedure and processes involved depend on the type of authorization
in place
•In smaller countries generally it is an administrative procedure requiring document
submission plus samples e.g. import certificate, GMP compliance certificate etc. and
can take between 2/3 weeks to 2 months
•In larger countries there is often a full regulatory procedure in place requiring
submission of complete regulatory dossier with quality, safety and efficacy sections,
and this procedure can take between 180 days to a full year; certificates and
samples also needed
•Information on regulatory processes generally available mostly in hard copy and on
application only; on line information is available in few countries
•Many countries state that guidelines are available but this in unclear and may have
been confused with guidance on procedures
Slide 11
13. Conclusions from Section 3: Process for the regulatory
procedure – continued.
•58% of responses declare implementation of, and compliance with VICH guidelines
•Well over two thirds of respondents say that guidelines on testing requirements
from overseas regulatory agencies are applied
•Samples of finished product are often required by most authorities
•Duration of authorization depends on type: an administrative procedure may only
be valid for one year whereas a full product license is valid for between 3 and 5
years (mostly the latter), and renewal applications are the norm
Slide 12
14. Conclusions from Section 4: Manufacture and Imports
•With the exception of one or two countries responses indicate that manufacture in
Africa requires authorization
•Requirements for local manufacture are very varied from a simple written request to
more sophisticated demands with applications to a number of ministries often
needed
•Rules for evidence of good manufacturing standards for imported vaccines are
more demanding and all such sites have to be approved by the authorities in the
foreign country concerned
•Documentary evidence is consistent and in most cases the vaccine must be
authorized for sale in exporting country
•Testing requirements for imported vaccines very similar for all countries, but one or
two countries require nothing
Slide 13
15. Conclusions from section 5: supervision and sanctions
•¾ of countries state that there is a pharmacovigilance system in operation?
•Very large majority of countries carry out inspections of manufacturing sites and or
distributor operations
•Less than half the countries undertake batch testing to underpin quality control
•Vaccines are removed form the market for a variety of reasons mostly as a result of
adverse reactions with concerns about safety or lack of efficacy as well as
manufacturing problems
Slide 14
16. Conclusions from Section 6: Labeling
Main languages required on labeling are as follows:
French in northern, western and central regions
English in southern and eastern regions
Arabic with French in many northern countries
Portuguese in Mozambique and Angola
Some other official languages in a few countries
Mandatory text on labels, outer packaging and ampoules
varies somewhat but is mostly consistent
Slide 15
17. General Provisions
Are there any arrangements in place for regular communication with other
countries?
- in Africa - outside Africa
•Responses are quite variable and show that within regions there is
ongoing dialogue between some countries
•In addition there are bilateral arrangements in place between e.g.
French speaking countries and the French authorities and English
speaking countries and the UK
•Little or no evidence of any structured mechanisms in place to
advance harmonization with the exception of l’UEMOA where
significant progress has been made.
Slide 16
18. So what have we learnt?
1. Evidence suggests that we have the basis for advancing greater harmonization
2. The building blocks are in place
3. If l’UEMOA can do it why not elsewhere?
4. Go carefully at first; mutual recognition prior to centralized systems are
preferred
5. This can happen if we commit to moving forward working together in
partnership
6. There is a momentum to go forward?
Slide 17
19. Working Groups
Slide 18
COUNTRY Region COUNTRY Region COUNTRY Region
1 Algeria N 12 Burundi E 19 Angola S
2 Morocco N 13 Kenya E 20 Botswana S
3 Tunisia N 14 Rwanda E 21 Dem Rep Congo S
4 Cameroon C 15 Seychelles E 22 Lesotho S
5 Congo - Brazzavile C 16 Sudan E 23 Madagascar S
6 Cote D'Ivoire W 17 Tanzania E 24 Malawi S
7 Ghana W 18 Uganda E 25 Mauritius S
8 Mali W 26 South Africa S
9 Mauritania W 27 Swaziland S
10 Nigeria W 28 Zambia S
11 Senegal W 29 Zimbabwe S
321
Chair: Cameroon
Rapporteurs: Nigeria & Algeria Chair: Kenya
Rapporteur: Tanzania
Chair: Botswana
Rapporteur: Zambia
20. Working Groups - Questions
1) What do you think are the benefits and advantages of the mutual recognition system
for your country, and can you suggest some initiatives to investigate how to progress
such a system?
2) Would your country be willing to participate in a Regional Forum of Regulatory
Authorities to continue to work on the way forward for mutual recognition and
harmonisation (if not doing so already)?
3) Now that PANVAC is fully operational as a “Centre of Excellence” for veterinary
vaccines on the African continent, how do you see its role in progressing such an
initiative (mutual recognition) with the support of the OIE?
4) a- If Regional Forums were set up, how does the group see the progress and
achievements of the Regional Forum, and what milestones would you like to see in
place to meet these achievements in 5 years time?
b- What would you think will be the challenges to achieve this, and possible
mitigation actions?
5) If certain members of your group are not convinced that the time is right to progress
just yet such a proposal; what more needs to be done before further consideration
can apply?
Slide 19
21. Question 1. What do you think are the benefits and advantages of the mutual
recognition system for your country, and can you suggest some initiatives
to investigate how to progress such a system?
The benefits of mutual recognition include:
The achievement of common standards for the authorization of veterinary vaccines
amongst the countries on a regional basis, to ensure the supply of high quality, safe and
efficacious products for disease prevention and control in Africa
A reduction in the cost of registration to the authorities by minimizing duplication and to
achieve savings in both financial and manpower resources thus speeding up the
regulatory processes
The encouragement of investment in the regions concerned by the legitimate animal
health industry, through a more efficient regional approach reducing the need for
individual applications in all countries and to reduce counterfeit products
Improving the provision of vaccines to livestock keepers at an affordable price
It provides a “regulatory capacity” for countries which do not have the resources to
undertake full regulatory procedures
22.
23.
24. Question 2. Would your country be willing to participate in a Regional Forum of
Regulatory Authorities to continue to work on the way forward for mutual
recognition and harmonisation (if not doing so already)?
YES FOR ALL 3 REGIONS
25. Question 3. Now that PANVAC is fully operational as a “Centre of Excellence” for veterinary
vaccines on the African continent, how do you see its role in
progressing such an initiative (mutual recognition)
with the support of OIE?
The role of PANVAC is seen as critically important and
essential to encourage a pan–African approach to
regulatory harmonisation, which at a regional level
translates into promoting the political support needed
amongst senior staff and policy /decision makers, to move
this initiative forward in all 3 regions supported by OIE in
accordance with the DAKAR recommendations
26. Question 4 a- If Regional Forums were set up, how does the group see the progress
and achievements of the Regional Forum, and what milestones would you like
to see in place to meet these achievements in 5 years time?
27. Question 4b- What would you think will be the challenges to achieve this, and
possible mitigation actions?
29. Dr Baptiste Dungu
Senior Director: R&D
Staff workshop
November 2009
GALVmed Training Workshop on Registration of
Veterinary Vaccines in Africa: Nairobi Kenya,
November 21-23, 2011
Developing and establishing a mutual recognition system for
authorizing vaccines. Peter Jones, - consultant to GALVmed