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4th African Regulatory Conference (ARC)

Oct 22 2014 7:00AM - Oct 23 2014 6:30PM | King Fahd Palace Hotel Pointe des Almadies Dakar, B.P. 8181 Senegal

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Overview 

Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa

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Online Registration

Download the Registration Form

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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 the participants of the 3rd ARC are saying:

"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 

  • African Medicines Regulatory Harmonisation (AMRH)
  • Guidelines development and implementation
  • Common technical documentation
  • Submission requirements
  • Dossier assessment
  • End-to-end submission and approval process mapping
  • Variations management
  • Quality/Good Manufacturing Practices (GMP)/Inspections
  • Transparency/Good Regulatory Practices
  • 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:

  • Provide a platform to foster collaboration between African regulatory authorities and the pharmaceutical industry
  • Share information and best practices
  • Openly discuss issues faced by African regulatory authorities and industry
  • Identify and agree on key proposals stemming from ARC discussions for further assessment and action

Strongly oriented towards informing on the current evolving regulatory landscape in Africa, and leveraging pragmatic and efficient approaches that strengthen ongoing harmonisation/convergence efforts, the conference will include panel discussions delivered during plenary and breakout sessions to maximise contributions from participants and enable deep-dived discussions of the key topics.

Special Offers 

Adjacent Events

21 October 2014

ICH endorsed Training Courses:

24 October 2014

IFPMA Workshop on Counterfeit medicines

Hotel & Travel 

Conference venue

King Fahd Palace Hotel

Pointe des Almadies

B.P. 8181, Dakar, Senegal

Tel: +221 33 869 69 69

www.kingfahdpalacehotels.com

 

 

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.

For more information please visit: www.mdtravelhealth.com/destinations/africa/senegal.php, www.iamat.org/country_profile.cfm?id=86#profile_immunization  http://www.traveldoctor.info/vaccinations/senegal.86.html#1

World Health Organisation (WHO) Global Alert and Response

World Health Organisation (WHO) International travel and health


 

Contact Information 

DIA has appointed Creative Trends to be the organising secretariat for the 4th African Regulatory Conference.

Conference Registration, Exhibitor Services, Accommodation, Transfers
Creative Trends
Osu Forico Mall, Mission Street
Near Blue Gate, Osu
P.O. Box AN 15605
Accra-North, Ghana
Tel: +233 243 288 505 or +233 200 814 184
E-mail: info@creativetrendsgh.com
or mabel@creativetrendsgh.com

Conference Programme
DIA Europe, Middle East & Africa
Kuechengasse 16
4051 Basel, Switzerland
Tel: +41 61 225 51 55
E-mail: gunta.sveke@diaeurope.org

Program Committee 

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Agenda  

Day 1 Tuesday, Oct 21, 2014

  • 4:00PM - 7:00PM (W. Central Africa Standard Time)

    PRE-CONFERENCE REGISTRATION

Day 2 Wednesday, Oct 22, 2014

  • 7:30AM - 8:30AM (W. Central Africa Standard Time)

    REGISTRATION & WELCOME COFFEE
  • 8:30AM - 9:15AM (W. Central Africa Standard Time)

    Session 1: Opening

    Speaker(s):

    • DIA Opening Remarks
      Jytte Lyngvig, PhD
      Senior Vice President and Managing Director, DIA EMEA
      DIA Europe, Middle East and Africa, Switzerland
    • Keynote Address
      Representative invited
      Ministry of Health and Prevention, Senegal
    • IFPMA / ARN Introduction
      Muriel Dona-Fologo
      GTA IRC Africa chairperson
      Sanofi, France
    • Welcome Note by Partners and Sponsors
      Vincent I. Ahonkhai, MD, FAAFP
      Senior Advisor, Global Health
      Bill & Melinda Gates Foundation, United States
    • Welcome Note by Partners and Sponsors
      Andreas Seiter
      Senior Health Specialist, Pharmaceuticals, Health, Nutrition & Population
      The World Bank, United States
  • 9:15AM - 9:45AM (W. Central Africa Standard Time)

    Session 2: Plenary - Current regulatory landscape in Africa - Latest developments

    Speaker(s):

    • 2008-2014 ARC roadmap
      Osaretin Jaiyeola
      Director, Regulatory Affairs - Sub-Saharan Africa
      GlaxoSmithKline, Ghana
    • Corneille Traore
      Director
      West African Economic and Monetary Union (UEMOA) , Burkina Faso
    • Vincent I. Ahonkhai, MD, FAAFP
      Senior Advisor, Global Health
      Bill & Melinda Gates Foundation, United States
  • 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

    This session will provide participants with an opportunity to get an update from regulatory agencies on the African Medicines Regulatory Harmonization (AMRH) programme. Key implementation learning amongst agencies and within the industry shall be shared in the 2nd part of the session.

    Speaker(s):

    • John Patrick Mwesigye
      Senior Health Officer (MRH)
      East African Community (EAC) Secretariat, Tanzania, United Republic of
    • Representative Invited
      Director GMP
      Pharmacy and Poisons Board
    • Sybil Nana Ama Ossei-Agyeman-Yeboah
      Professional Officer in Charge, Essential Medicines and Vaccines
      West African Health Organisation (WAHO), Burkina Faso
    • Emilienne Yissibi Pola
      Public Health Pharmacist, Consultant HPPN/OCEAC
      Organisation of the fight against endemic diseases in central Africa (OCEAC), Cameroon
    • Corneille Traore
      Director
      West African Economic and Monetary Union (UEMOA) , Burkina Faso
    • Representative Invited
      Senior Programme Officer for Health and Pharmaceuticals
      Southern African Development Community (SADC)
  • 10:30AM - 11:00AM (W. Central Africa Standard Time)

    NETWORKING COFFEE BREAK IN THE EXHIBITION AREA
  • 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):

    • William Mwatu
      Regulatory Affairs Director DC, Emerging Markets & Asia Pac
      GSK / Kenya Association of the Pharmaceutical Industry (KAPI), Kenya
    • Petra Doerr, PharmD
      Head of Communication and Networking, Deputy Director
      Swissmedic, Switzerland
    • Ricardo H. Cavazos Cepeda
      Chief of Staff
      Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico
    • Samvel Azatyan, MD, PhD
      Group Lead, Capacity Building and Harmonization Support
      World Health Organization (WHO), Switzerland
  • 12:30PM - 2:00PM (W. Central Africa Standard Time)

    LUNCH BREAK - EXHIBITION AREA
  • 2:00PM - 3:30PM (W. Central Africa Standard Time)

    Session 4: Parallel 1 - How to reach one dossier for all. Good review practices and regulatory convergence in Africa

    Speaker(s):

    • Amadou Moctar Dieye
      Director
      Direction de la Pharmacie et du Medicament, Senegal
    • Hiiti Baran Sillo
      Director General
      Tanzania Food and Drugs Authority (TFDA), Tanzania, United Republic of
  • 2:00PM - 3:30PM (W. Central Africa Standard Time)

    Session 4: Parallel 2 - Improving GMP compliance in Africa; The Need to Create an Opportunity for Pragmatic Dialogue between MRA and Industry

    Speaker(s):

    • Cheikh Tidiane Ba
      Country Manager West Africa
      Pfizer Global Pharmaceuticals, Nigeria
  • 2:00PM - 3:30PM (W. Central Africa Standard Time)

    Session 4: Parallel 3 - Clinical Trial – Challenges and Opportunities in Building Capacity


    Session Chair(s):

    • Delese Mimi Darko
      Ag. DCE; Safety Monitoring & Clinical Trials Division
      Food and Drugs Authority, Ghana
    • Perry Mohammed (TBC)
      Medical Director Global Publich Health
      Janssen, Pharmaceutical Companies of Johnson & Johnson, United Kingdom

    Moderator: Perry Mohammed (TBC)
    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):

    • Representative Invited
      Assistant Regional Director
      Research & Development new Vaccines, Immunisation and Vaccines Development Progr
    • Delese Mimi Darko
      Ag. DCE; Safety Monitoring & Clinical Trials Division
      Food and Drugs Authority, Ghana
    • Perry Mohammed (TBC)
      Medical Director Global Publich Health
      Janssen, Pharmaceutical Companies of Johnson & Johnson, United Kingdom
    • Thomas Nyirenda, MD, MS
      South-South Networking and Capacity Development Manager
      European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa
  • 3:30PM - 4:00PM (W. Central Africa Standard Time)

    NETWORKING COFFEE BREAK WITH EXHIBITORS
  • 4:00PM - 4:30PM (W. Central Africa Standard Time)

    Session 4: Break-out 1 cont. - How to reach one dossier for all. Good review practices and regulatory convergence in Africa
  • 4:00PM - 4:30PM (W. Central Africa Standard Time)

    Session 4: Break-out 2 cont. - Improving GMP compliance in Africa; The Need to Create an Opportunity for Pragmatic Partnering between MRA and Industry
  • 4:00PM - 4:30PM (W. Central Africa Standard Time)

    Session 4: Break-out 3 cont. - Clinical trials in Africa – Challenges and opportunities in building capacity
  • 4:30PM - 5:30PM (W. Central Africa Standard Time)

    Session 5: Plenary - Recap from parallel sessions, discussions and wrap-up

    Speaker(s):

    • Hiiti Baran Sillo
      Director General
      Tanzania Food and Drugs Authority (TFDA), Tanzania, United Republic of
    • Cheikh Tidiane Ba
      Country Manager West Africa
      Pfizer Global Pharmaceuticals, Nigeria
    • Perry Mohammed (TBC)
      Medical Director Global Publich Health
      Janssen, Pharmaceutical Companies of Johnson & Johnson, United Kingdom
    • Delese Mimi Darko
      Ag. DCE; Safety Monitoring & Clinical Trials Division
      Food and Drugs Authority, Ghana
  • 5:30PM - 7:00PM (W. Central Africa Standard Time)

    NETWORKING RECEPTION

Day 3 Thursday, Oct 23, 2014

  • 8:30AM - 9:00AM (W. Central Africa Standard Time)

    Session 6: Opening - Reflexions and overview from Day One & Introduction to Day Two


    Session Chair(s):

    • 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

    Speaker(s):

    • Fabienne Y. Benoist, PhD
      Global brand regulatory director, Tropical medicines, Malaria initiative lead
      Novartis AG, Switzerland
    • Osaretin Jaiyeola
      Director, Regulatory Affairs - Sub-Saharan Africa
      GlaxoSmithKline, Ghana
  • 9:00AM - 10:30AM (W. Central Africa Standard Time)

    Session 7: Plenary - Optimised dossier review process


    Session Chair(s):

    • Milan Smid, MD, PhD
      Department of Essential Medicines and Health Products (EMP)
      World Health Organization (WHO), Switzerland

    Dossier review processes in different African countries are evolving over time and new registration requirements are being implemented. Variety and differences in requirements have led to increased review timelines and prolonged access for patients to medicines. This session targets to evaluate possibilities to optimise dossier review processes in different African regions and countries. Input will be brought in from the European Union where collaboration between countries has evolved and led to a harmonised approach and work-sharing between countries. The current situation in Africa will be analysed and recommendations be given how to improve processes, and show possibilities for harmonisation and collaboration between African countries.

    Speaker(s):

    • Aristide Ateba Etoundi
      Director of Pharmacy, Drugs and Laboratories
      Medicines and Laboratories at the Ministry of Public Health, Cameroon
    • Amadou Moctar Dieye
      Director
      Direction de la Pharmacie et du Medicament, Senegal
    • Margareth Ndomondo-Sigonda
      Pharmaceutical Coordinator
      The New Partnership For Africa's Development (NEPAD), South Africa
  • 10:30AM - 11:00AM (W. Central Africa Standard Time)

    NETWORKING COFFEE BREAK IN THE EXHIBITION AREA
  • 11:00AM - 12:00PM (W. Central Africa Standard Time)

    Session 8: Parallel 1 - New/expedite regulatory pathways


    Session Chair(s):

    • Vincent I. Ahonkhai, MD, FAAFP
      Senior Advisor, Global Health
      Bill & Melinda Gates Foundation, United States

    This session will give an overview of new / expedite regulatory pathways for medicines and vaccines, as well as analyse lessons learned from existing pathways: what could be replicated and what should be avoided. Opportunities and recommendations will be discussed.

    Speaker(s):

    • Milan Smid, MD, PhD
      Department of Essential Medicines and Health Products (EMP)
      World Health Organization (WHO), Switzerland
  • 11:00AM - 12:00PM (W. Central Africa Standard Time)

    Session 8: Parallel 2 - The complex journey of a vaccine – Questions on access from a regulatory angle

    Speaker(s):

    • Christophe Saillez
      Senior Manager
      GSK Biologicals, Belgium
    • Representative Invited
      Director GMP
      Pharmacy and Poisons Board
  • 11:00AM - 12:00PM (W. Central Africa Standard Time)

    Session 8: Parallel 3 - Capacity building – Training of medicines development and regulatory sciences in emerging countries

    Speaker(s):

    • Representative Invited
      Director
      Centre for Tropical Clinical Pharmacology & Therapeutics
    • Sandor Kerpel-Fronius
      Project Academic Leader
      Cooperative European Medicines Development Course (CEMDC), Hungary
    • Margareth Ndomondo-Sigonda
      Pharmaceutical Coordinator
      The New Partnership For Africa's Development (NEPAD), South Africa
    • Representative Invited
      Director General
      National Agency for Food and Drug Administration and Control (NAFDAC)
  • 12:00PM - 12:30PM (W. Central Africa Standard Time)

    Session 9: Plenary - Recap from break-out sessions

    Speaker(s):

    • Vincent I. Ahonkhai, MD, FAAFP
      Senior Advisor, Global Health
      Bill & Melinda Gates Foundation, United States
    • Milan Smid, MD, PhD
      Department of Essential Medicines and Health Products (EMP)
      World Health Organization (WHO), Switzerland
  • 12:30PM - 2:00PM (W. Central Africa Standard Time)

    LUNCH BREAK - EXHIBITION AREA
  • 2:00PM - 3:30PM (W. Central Africa Standard Time)

    Session 10: Parallel 1 - Regulators' closed panel discussion


    Session Chair(s):

    • Representative Invited
      Group Lead, Capacity Building and Harmonization Support
      World Health Organization (WHO)
    • Amadou Moctar Dieye
      Director
      Direction de la Pharmacie et du Medicament, Senegal

    Moderator: TBC
    Rapporteur: Amadou Moctar Dieye

    This session is set-up as a panel discussion with regulators representatives only. Main discussion points, comments and recommendations from this session as recorded by a rapporteur will be shared during next plenary session. Regulators’ views of needs and opportunities for improvement related to the discussion points will be brought into perspective with each other during the session.

    Discussant(s):

    • 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
    • Representative Invited
      Chief Director, Department of Health
      Medicines Regulatory Authority
    • 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
    • Margareth Ndomondo-Sigonda
      Pharmaceutical Coordinator
      The New Partnership For Africa's Development (NEPAD), South Africa
    • 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
  • 2:00PM - 3:30PM (W. Central Africa Standard Time)

    Session 10: Parallel 2 - Industry and Stakeholders’ closed panel discussion


    Session Chair(s):

    • Sharon N. Olmstead
      Global Head, Development and Regulatory Policy
      Novartis Pharmaceuticals Corporation, United States

    Moderator: Sharon Olmstead
    Rapporteur: TBC

    This session is set-up as a panel discussion with industry representatives only. Main discussion points, comments and recommendations from this session as recorded by a rapporteur will be shared during next plenary session. Industry’s views of needs and opportunities for improvement related to the discussion points will be brought into perspective during the session.

    Discussant(s):

    • Cheikh Tidiane Ba
      Country Manager West Africa
      Pfizer Global Pharmaceuticals, Nigeria
    • Perry Mohammed (TBC)
      Medical Director Global Publich Health
      Janssen, Pharmaceutical Companies of Johnson & Johnson, United Kingdom
    • William Mwatu
      Regulatory Affairs Director DC, Emerging Markets & Asia Pac
      GSK / Kenya Association of the Pharmaceutical Industry (KAPI), Kenya
    • Sharmila Parsotam
      Senior Director
      Pfizer, United Kingdom
    • Christophe Saillez
      Senior Manager
      GSK Biologicals, Belgium
  • 3:30PM - 4:00PM (W. Central Africa Standard Time)

    NETWORKING COFFEE BREAK WITH EXHIBITORS
  • 4:00PM - 4:45PM (W. Central Africa Standard Time)

    Session 11: Plenary - Recap from break-out sessions

    Speaker(s):

    • Representative Invited
      Group Lead, Capacity Building and Harmonization Support
      World Health Organization (WHO)
    • Amadou Moctar Dieye
      Director
      Direction de la Pharmacie et du Medicament, Senegal
    • Sharon N. Olmstead
      Global Head, Development and Regulatory Policy
      Novartis Pharmaceuticals Corporation, United States
  • 4:45PM - 6:30PM (W. Central Africa Standard Time)

    Session 12: Closing - Challenges/barriers to access medicines


    Session Chair(s):

    • 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

    Speaker(s):

    • Recommendations from the Conference
      Vincent I. Ahonkhai, MD, FAAFP
      Senior Advisor, Global Health
      Bill & Melinda Gates Foundation, United States
    • Mercè Caturla
      Global Access Regulatory Lead (WHO/Africa/MEWA/EAP)
      Janssen Infectious Diseases, Belgium
    • Osaretin Jaiyeola
      Director, Regulatory Affairs - Sub-Saharan Africa
      GlaxoSmithKline, Ghana
    • Robert Lebeda
      Regulatory Affairs Manager
      Eli Lilly GmbH, Austria
    • Caroline Mendy
      Manager, Regulatory Policy
      International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Switzerland
    • Challenges / barriers to access medicines
      Corneille Traore
      Director
      West African Economic and Monetary Union (UEMOA) , Burkina Faso

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 Manger at roxann.schumacher@diaeurope.org or call +41 61 225 51 38.

Registration Fees 

Other Fees

Government/Nonprofit/Academia Overseas
€350.00
Industry Overseas
€1500.00
Government/Nonprofit/Academia Africa
€220.00
Industry Africa
€650.00
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