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King Fahd Palace Hotel

Apr 27, 2015 7:00 AM - Apr 28, 2015 6:30 PM

Pointe des Almadies, Dakar, B.P. 8181, Senegal

4th African Regulatory Conference

Overview

Press release

 

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Moving towards Regulatory Harmonisation to enhance Access to Medicines in Africa

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This is the 4th African Regulatory Conference co-organised by the 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 African Regulatory Conference 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 for plenary sessions only.

To view detailed programme please click on View PDF above.

The 4th African Regulatory Conference is co-organised by

EMA

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What participants of the 3rd African Regulatory Conference 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."

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Read the latest DIA Global Forum article on the 4th African Regulatory Conference

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

Featured

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Continuing-Education

Exhibits

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 African Regulatory Conference 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 African Regulatory Conference 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 conference 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.

Program Committee

  • Vincent I. Ahonkhai, MD, FAAFP
    Vincent I. Ahonkhai, MD, FAAFP Senior Advisor, Global Health
    Bill & Melinda Gates Foundation, United States
  • Corneille  Traore
    Corneille Traore Director
    West African Economic and Monetary Union (UEMOA) , Burkina Faso
  • Nouara  Ait-Aider
    Nouara Ait-Aider Global Regulatory Affairs, RA ITC - Africa
    Sanofi Aventis R&D, France
  • Cristina  Arnes Munoz
    Cristina Arnes Munoz Policy Analyst
    IFPMA, Switzerland
  • Fabienne Y. Benoist, PhD, MPH
    Fabienne Y. Benoist, PhD, MPH Head of Regulatory Affairs
    DNDi, Switzerland
  • Mercè  Caturla Goñi
    Mercè Caturla Goñi Global Access Regulatory Leader, Regulatory Policy (Africa and WHO)
    Janssen Pharmaceutical Companies of Johnson & Johnson, Belgium
  • Paul  Dearden
    Paul Dearden Senior Director, Global Regulatory Policy
    Biogen, United Kingdom
  • Muriel  DONA-FOLOGO, MD
    Muriel DONA-FOLOGO, MD Head of Regulatory Affairs ICMEA
    Takeda, United Arab Emirates
  • Valérie  Faillat-Proux, PharmD
    Valérie Faillat-Proux, PharmD Regulatory Affairs Senior Director - Access to Medicines
    Sanofi, France
  • Bunmi  Femi-Oyekan
    Bunmi Femi-Oyekan Director, Regulatory Affairs
    Pfizer Specialities Ltd, Nigeria
  • Osaretin  Jaiyeola, MPharm
    Osaretin Jaiyeola, MPharm Managing Director & Principal Partner
    Fensyl MHP Consulting Limited, Nigeria
  • Robert  Lebeda
    Robert Lebeda Manager Global Regulatory Affairs - International
    Eli Lilly Regional Gmbh, Austria
  • Caroline  Mendy
    Caroline Mendy Manager, Regulatory Policy
    IFPMA, Switzerland
  • John  Mwangi
    John Mwangi Head of Regulatory Affairs - Middle Africa
    Bayer East Africa Ltd, Kenya
  • Sharmila  Parsotam
    Sharmila Parsotam Senior Director
    Pfizer, United Kingdom
  • Dakshina  Reddy
    Dakshina Reddy VP Regulatory
    Altimmune, United States
  • Christophe  Saillez
    Christophe Saillez Senior Manager
    GSK Biologicals, Belgium
  • Myriam  Sedrati
    Myriam Sedrati Regulatory Affairs Director North and West Africa
    Merck Sharp & Dohme, Morocco
  • Nathalie  Tatarczuk
    Nathalie Tatarczuk Regulatory Affair Pharmacist
    Merck Sharp & Dohme, Morocco

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Registration fee includes conference delegate material, refreshments and lunches.
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