Friday, December 5, 2014

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.

----------------------------------------------------------------------------------------------------
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 

  • 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
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.

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

Program Committee 

Next

Agenda  

Day 1 Monday, Apr 27, 2015

  • 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 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
  • 9:15AM - 9:45AM (W. Central Africa Standard Time)
    Session 2: Plenary - Current regulatory landscape in Africa - Latest developments
    Speaker(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
  • 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):
    • 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
  • 10:30AM - 11:00AM (W. Central Africa Standard Time)
    COFFEE BREAK & NETWORKING 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):
    • 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
  • 12:30PM - 2:00PM (W. Central Africa Standard Time)
    LUNCH & NETWORKING IN THE EXHIBITION AREA
  • 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
    Moderator: Elliot P. Simonian
    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
  • 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
    Moderator: Carl Engleman
    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
  • 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
    Moderator: Kirti Narsai
    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
  • 3:30PM - 4:00PM (W. Central Africa Standard Time)
    COFFEE BREAK & NETWORKING IN THE EXHIBITION AREA
  • 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
  • 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
  • 4:00PM - 4:30PM (W. Central Africa Standard Time)
    Session 4: Workshop C 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 workshops, discussions and wrap-up
    Speaker(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
  • 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.

Registration Fees 

Other Fees

Government/Nonprofit/Academia Overseas
€350.00
Industry Overseas
€1500.00
Government/Nonprofit/Academia Africa
€220.00
Industry Africa
€650.00
Registration Information Registration fee includes conference delegate material, refreshments and lunches.

No comments:

Post a Comment