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Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa
***********************************************************************************Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa
This is the 4th African Regulatory Conference (ARC) co-organised by the Drug Information Association (DIA) and the IFPMA’s African Regulatory Network (ARN).
IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) represents the research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees strive to develop and provide innovative medicines, biological products, and vaccines that improve patients’ lives worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.
The ARN is an ad-hoc network of the Regulatory Policy and Technical Standards Committee (RPTS) of IFPMA. The association works in partnership with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonisation of regulatory requirements with the aim to help enable faster and expanded access to good quality innovative medicines for patients.
The ARC offers the opportunity for key stakeholders active in the region including Representatives from health authorities, local and multinational pharmaceutical companies, international, governmental and non-governmental organisations to exchange progressive views on key topics of interest and identify focus areas for ongoing efforts aimed to increase patient access to new and improved medicines.
Simultaneous translation in French and English will be available.
To view detailed programme please click on View PDF above.
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What participants of the 3rd ARC said:
"A well placed conference which has fostered the sharing of information and best practices and openly discussion delegates regarding issues facing African Regulatory authorities and industry. Great job done."
"It’s the 3rd conference to attend. I appreciate the learning received in all ARC’s."
"The meeting is a very good platform of exchange and we have learned lessons which can help us when we are back in our country."
Featured Topics
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African Medicines Regulatory Harmonisation (AMRH)
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Guidelines development and implementation
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Common technical documentation
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Submission requirements
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Dossier assessment
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End-to-end submission and approval process mapping
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Variations management
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Quality / Good Manufacturing Practices (GMP) / Inspections
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Transparency / Good Regulatory Practices
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Clinical trials capacity building
Who Should Attend
Representatives of health authorities, regulatory affairs, quality assurance,
medical, safety, research and development professionals, and other professionals
involved in or interested in the aspects surrounding registration of medicinal
products and regulatory harmonisation initiatives in Africa.
Learning Objectives
Following the successful discussions held during the 3rd ARC in
2012 in Ghana, this edition intends to build on progress made within the region
and to identify further initiatives for stakeholders to work together on the
enhancement of healthcare in Africa.
This 4th ARC will provide an overview of regulatory
harmonisation initiatives currently ongoing or emerging in Africa and will offer
the opportunity to:
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Provide a platform to foster collaboration between African regulatory authorities and the pharmaceutical industry
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Share information and best practices
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Openly discuss issues faced by African regulatory authorities and industry
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Identify and agree on key proposals stemming from ARC discussions for further assessment and action
Special Offers
Adjacent Events
26 April 2015
Training Courses:
29 April 2015
IFPMA Workshop on Counterfeit medicines
Hotel & Travel
Conference venueKing Fahd
Palace Hotel
Pointe des Almadies
B.P. 8181, Dakar, Senegal
Tel: +221 33 869 69 69
www.kingfahdpalacehotels.com
The hotel booking can be made together with the conference registration.
Visa requirements
Please contact your local Senegal Embassy or Consulate for the most up-to-date information on visa requirements and how to apply for it if necessary.
For more information please visit: www.snedai.sn
Vaccinations
Please contact your GP for recommended vaccinations at least 4-8 weeks before travelling to Senegal.
Pointe des Almadies
B.P. 8181, Dakar, Senegal
Tel: +221 33 869 69 69
www.kingfahdpalacehotels.com
The hotel booking can be made together with the conference registration.
Visa requirements
Please contact your local Senegal Embassy or Consulate for the most up-to-date information on visa requirements and how to apply for it if necessary.
For more information please visit: www.snedai.sn
Vaccinations
Please contact your GP for recommended vaccinations at least 4-8 weeks before travelling to Senegal.
Contact Information
DIA has appointed Creative Trends to be the organising secretariat for the
4th African Regulatory Conference.
Registration
Creative Trends
Osu Forico Mall, Mission Street
Near Blue Gate, Osu
P.O. Box AN 15605
Accra-North, Ghana
Tel: +233 243 288 505
info@creativetrendsgh.com
Conference Programme
DIA Europe, Middle East & Africa
Kuechengasse 16
4051 Basel, Switzerland
Tel: +41 61 225 51 55
gunta.sveke@diaeurope.org
Exhibition
Roxann Schumacher
Tel: +41 61 225 51 38
roxann.schumacher@diaeurope.org
Registration
Creative Trends
Osu Forico Mall, Mission Street
Near Blue Gate, Osu
P.O. Box AN 15605
Accra-North, Ghana
Tel: +233 243 288 505
info@creativetrendsgh.com
Conference Programme
DIA Europe, Middle East & Africa
Kuechengasse 16
4051 Basel, Switzerland
Tel: +41 61 225 51 55
gunta.sveke@diaeurope.org
Exhibition
Roxann Schumacher
Tel: +41 61 225 51 38
roxann.schumacher@diaeurope.org
Program Committee
Next
Bill & Melinda Gates Foundation, United States
West African Economic and Monetary Union (UEMOA) , Burkina Faso
Sanofi Aventis R&D, France
Amgen, United Kingdom
Novartis Pharma AG, Switzerland
Janssen Infectious Diseases, Belgium
Sanofi, France
GlaxoSmithKline, Ghana
Eli Lilly GmbH, Austria
Bayer Healthcare, Kenya
Pfizer, United Kingdom
Novartis South Africa (Pty) Ltd, South Africa
Merck Sharp & Dohme, Morocco
Program Committee 1-3 of
13
Vincent I. Ahonkhai, MD, FAAFP
Senior Advisor, Global HealthBill & Melinda Gates Foundation, United States
Corneille Traore
DirectorWest African Economic and Monetary Union (UEMOA) , Burkina Faso
Nouara Ait-Aider
Global Regulatory Affairs, RA ITC - AfricaSanofi Aventis R&D, France
Program Committee 4-6 of
13
Arfan Ashraf
Manager: Global Regulatory Affairs - InternationalAmgen, United Kingdom
Fabienne Y. Benoist, PhD
Tropical Medicines Global Brand Regulatory DirectorNovartis Pharma AG, Switzerland
Mercè Caturla
Global Access Regulatory Lead (WHO/Africa/MEWA/EAP)Janssen Infectious Diseases, Belgium
Program Committee 7-9 of
13
Muriel Dona-Fologo
GTA IRC Africa chairpersonSanofi, France
Osaretin Jaiyeola
Director, Regulatory Affairs - Sub-Saharan AfricaGlaxoSmithKline, Ghana
Robert Lebeda
Regulatory Affairs ManagerEli Lilly GmbH, Austria
Program Committee 10-12
of 13
John Mwangi
Regulatory Affairs SpecialistBayer Healthcare, Kenya
Sharmila Parsotam
Senior DirectorPfizer, United Kingdom
Dakshina Reddy
Director – DRA Head: South Africa and Southern Africa GroupNovartis South Africa (Pty) Ltd, South Africa
Program Committee 13-13
of 13
Myriam Sedrati
Regulatory Affairs Director North and West AfricaMerck Sharp & Dohme, Morocco
Agenda
Day 1 Monday, Apr 27, 2015
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7:30AM - 8:30AM (W. Central Africa Standard Time)REGISTRATION & WELCOME COFFEE
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8:30AM - 9:15AM (W. Central Africa Standard Time)Session 1: OpeningSpeaker(s):
- DIA Opening RemarksJytte Lyngvig, PhD
Senior Vice President and Managing Director, DIA EMEA
DIA Europe, Middle East and Africa, Switzerland - Keynote AddressRepresentative Invited
Minister of Health
Ministry of Health and Prevention - IFPMA / ARN IntroductionMuriel Dona-Fologo
GTA IRC Africa chairperson
Sanofi, France - Welcome Note by Partners and SponsorsVincent I.
Ahonkhai, MD, FAAFP
Senior Advisor, Global Health
Bill & Melinda Gates Foundation, United States - Welcome Note by Partners and SponsorsAndreas
Seiter
Senior Health Specialist, Pharmaceuticals, Health, Nutrition & Population
The World Bank, United States
- DIA Opening RemarksJytte Lyngvig, PhD
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9:15AM - 9:45AM (W. Central Africa Standard Time)Session 2: Plenary - Current regulatory landscape in Africa - Latest developmentsSpeaker(s):
- 2008-2014 ARC roadmapOsaretin Jaiyeola
Director, Regulatory Affairs - Sub-Saharan Africa
GlaxoSmithKline, Ghana - Vincent I. Ahonkhai, MD, FAAFP
Senior Advisor, Global Health
Bill & Melinda Gates Foundation, United States - Corneille Traore
Director
West African Economic and Monetary Union (UEMOA) , Burkina Faso
- 2008-2014 ARC roadmapOsaretin Jaiyeola
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9:45AM - 10:30AM (W. Central Africa Standard Time)Session 3 Part 1: Plenary - Leveraging activities between regulatory agencies / bodies
Session Chair(s):- Corneille Traore
Director
West African Economic and Monetary Union (UEMOA) , Burkina Faso
Speaker(s):- Representative Invited
Senior Programme Officer for Health and Pharmaceuticals
Southern African Development Community (SADC) - John Patrick Mwesigye
Senior Health Officer (MRH)
East African Community (EAC) Secretariat, Tanzania, United Republic of - Sybil Nana Ama Ossei-Agyeman-Yeboah
Professional Officer in Charge, Essential Medicines and Vaccines
West African Health Organisation (WAHO), Burkina Faso - Corneille Traore
Director
West African Economic and Monetary Union (UEMOA) , Burkina Faso - Representative Invited
Director GMP
Pharmacy and Poisons Board - Emilienne Yissibi Pola
Public Health Pharmacist, Consultant HPPN/OCEAC
Organisation of the fight against endemic diseases in central Africa (OCEAC), Cameroon
- Corneille Traore
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10:30AM - 11:00AM (W. Central Africa Standard Time)COFFEE BREAK & NETWORKING IN THE EXHIBITION AREA
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11:00AM - 12:30PM (W. Central Africa Standard Time)Session 3 Part 2: Plenary - Leveraging activities between regulatory agencies / bodies
Session Chair(s):- Corneille Traore
Director
West African Economic and Monetary Union (UEMOA) , Burkina Faso
Speaker(s):- Samvel Azatyan, MD, PhD
Group Lead, Capacity Building and Harmonization Support
World Health Organization (WHO), Switzerland - Ricardo H. Cavazos Cepeda
Chief of Staff
Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico - Petra Doerr, PharmD
Head of Communication and Networking, Deputy Director
Swissmedic, Switzerland - William Mwatu
Representative
Kenya Association of the Pharmaceutical Industry (KAPI), Kenya
- Corneille Traore
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12:30PM - 2:00PM (W. Central Africa Standard Time)LUNCH & NETWORKING IN THE EXHIBITION AREA
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2:00PM - 3:30PM (W. Central Africa Standard Time)Session 4: Workshop A - How to Reach One Dossier for All: Good review practices and regulatory convergence in Africa
Session Chair(s):- Elliot P. Simonian
Director, Emerging Markets, Global Regulatory Affairs
GlaxoSmithKline, United Kingdom - Hiiti Baran Sillo
Director General
Tanzania Food and Drugs Authority (TFDA), Tanzania, United Republic of
Rapporteur: Hiiti Baran Sillo
This session will be a panel discussion between regulatory agencies and the representatives of the industry. It is an opportunity to share and exchange the experiences of each counterpart (dossier preparation for the industries and dossier evaluation for the authorities)
Speaker(s):- Amadou Moctar Dieye
Director
Direction de la Pharmacie et du Medicament, Senegal
- Elliot P. Simonian
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2:00PM - 3:30PM (W. Central Africa Standard Time)Session 4: Workshop B - Improving GMP Compliance in Africa; The need to create an opportunity for pragmatic dialogue between MRA and industry
Session Chair(s):- Carl Engleman
Country Manager, Nigeria & East Africa Region
Pfizer, United Arab Emirates
Rapporteur: TBC
How can we move towards a proactive, mutual process improvement of the current change control process across the African region such that supply continues without disruption and patients do not suffer when shortages are avoidable?
Speaker(s):- Christa Wirthumer-Hoche, PhD
Head of AGES
Austrian Medicines and Medical Devices Agency, Austria
- Carl Engleman
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2:00PM - 3:30PM (W. Central Africa Standard Time)Session 4: Workshop C - Clinical Trials in Africa – Challenges and opportunities in building capacity
Session Chair(s):- Kirti Narsai
Director, Government Affairs and Policy
Johnson & Johnson Medical, South Africa - Delese Mimi Darko
Ag. DCE; Safety Monitoring & Clinical Trials Division
Food and Drugs Authority, Ghana
Rapporteur: Delese Mimi Darko
Participants will hear from regulators and industry about the status of clinical trials in Africa. The capacity building situation and its impact in multi-regional clinical trials, the role of the Regulators in reviewing the trial protocol to ensure safety for its population, the appropriateness of its scientific design, and that the protocol will be executed ethically will also be discussed
Speaker(s):- Bartholomew Dicky Akanmori
Assistant Regional Director
Research & Development new Vaccines, Immunisation and Vaccines Development Progr, Congo, the Democratic Republic of the - Delese Mimi Darko
Ag. DCE; Safety Monitoring & Clinical Trials Division
Food and Drugs Authority, Ghana - Kirti Narsai
Director, Government Affairs and Policy
Johnson & Johnson Medical, South Africa - Thomas Nyirenda, MD, MS
South-South Networking and Capacity Development Manager
European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa
- Kirti Narsai
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3:30PM - 4:00PM (W. Central Africa Standard Time)COFFEE BREAK & NETWORKING IN THE EXHIBITION AREA
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4:00PM - 4:30PM (W. Central Africa Standard Time)Session 4: Workshop A cont. - How to Reach One Dossier for All: Good review practices and regulatory convergence in Africa
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4:00PM - 4:30PM (W. Central Africa Standard Time)Session 4: Workshop B cont. - Improving GMP Compliance in Africa; The need to create an opportunity for pragmatic partnering between MRA and industry
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4:00PM - 4:30PM (W. Central Africa Standard Time)Session 4: Workshop C cont. - Clinical Trials in Africa – Challenges and opportunities in building capacity
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4:30PM - 5:30PM (W. Central Africa Standard Time)Session 5: Plenary - Recap from parallel workshops, discussions and wrap-upSpeaker(s):
- Hiiti Baran Sillo
Director General
Tanzania Food and Drugs Authority (TFDA), Tanzania, United Republic of - Delese Mimi Darko
Ag. DCE; Safety Monitoring & Clinical Trials Division
Food and Drugs Authority, Ghana - Elliot P. Simonian
Director, Emerging Markets, Global Regulatory Affairs
GlaxoSmithKline, United Kingdom - Carl Engleman
Country Manager, Nigeria & East Africa Region
Pfizer, United Arab Emirates - Kirti Narsai
Director, Government Affairs and Policy
Johnson & Johnson Medical, South Africa
- Hiiti Baran Sillo
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5:30PM - 7:00PM (W. Central Africa Standard Time)NETWORKING RECEPTION IN THE EXHIBITION HALL
Day 2 Tuesday, Apr 28, 2015
Exhibits
This conference gives the opportunity to a limited number of organisations to
present themselves to the key stakeholders in the field through 6 sqm
mini-booths.
Exhibitors are granted a unique opportunity to meet attendees before and after sessions and during all breaks. As there are only a very limited number of booths available, high visibility can be guaranteed. The mini-booths will be positioned to fit naturally into the flow of conference traffic, so the opportunities to engage with attendees are ensured.
ARC Exhibitor Application Form
For more details, please contact Roxann Schumacher, Exhibits Manager at roxann.schumacher@diaeurope.org or call +41 61 225 51 38.
Exhibitors are granted a unique opportunity to meet attendees before and after sessions and during all breaks. As there are only a very limited number of booths available, high visibility can be guaranteed. The mini-booths will be positioned to fit naturally into the flow of conference traffic, so the opportunities to engage with attendees are ensured.
ARC Exhibitor Application Form
For more details, please contact Roxann Schumacher, Exhibits Manager at roxann.schumacher@diaeurope.org or call +41 61 225 51 38.
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