29 April, 2015

07:30 to 16:00UTC±00:00

IFPMA Counterfeit Workshops

IFPMA Counterfeit Workshops

KING FAHD PALACE HOTEL, Pointe des Almadies, Dakar 8181, Senegal

Absent or weak national medicines regulatory system is mentioned by the World Health Organization as one factor encouraging counterfeiting of medicines, as well as lack of appropriate medicine legislation and weak enforcement.
In this context, IFPMA organizes full-day workshops on counterfeit medicines on margin of the IFPMA – DIA regulatory conferences in Asia and Africa.
The workshops intend to promote an integrated approach to fighting counterfeit medicines. The workshops will provide a venue to discuss best practices against fake medicines addressing in particular current regulatory landscape and initiatives; supply chain integrity; practices and technologies for prevention, detection, control and monitoring of fake medicines; and collaboration within and between countries.
The workshop will gather international and regional speakers and feature multistakeholder expertise thanks to the participation of representatives from national regulatory authorities, regional intergovernmental organizations, international organizations, non-governmental organizations and private sectors.
Audience will include regulatory affairs professionals, representatives of regulatory authorities and other professionals involved in fighting fake medicines. Simultaneous translation in Chinese and English will be provided
The Asian workshop took place in February 2015 in Taiwan; the African workshop will be held on April 2015 in Senegal.

07:30 – 08:30

REGISTRATION & WELCOME COFFEE


08:30 – 09:10

OPENING SESSION – INTEGRATED AND HARMONIZED APPROACH AGAINST FAKE MEDICINES
• Opening Remarks
Marc Gentilini, fondation Chirac
• Keynote Address
TBC
• Introduction by co-Chairs
Corneille Traore, West African Economic and Monetary Union
Hiiti B. Sillo, Tanzania Food and Drugs Authority


09:10 – 10:30

SESSION 1: CURRENT REGULATORY LANDSCAPE & INITIATIVES AGAINST FAKE MEDICINES
• Global approach
Jean-Baptiste Nikiema, World Health Organization, Regional Office for Africa
• Continental approach
Margareth Ndomondo-Sigonda, New Partnership for Africa's Development
• Regional approach
Sybil Ossei - Agyeman- Yeboah, West African Health Organization
Patrick Mwesigye , East African Community
Emilienne Yissibi Pola, Organization for Cooperation in the Fight against Major Endemic Diseases in Central Africa (OCEAC)
• Questions and Answers


10:30 – 11:00

COFFEE BREAK


11:00 – 11:50

SESSION 2: SUPPLY CHAIN INTEGRITY
• Complexity of the supply chain
Beverley Bedford, RX360
• GS1 Standards – securing supply chain globally
Christian Hay, GS1
• Countries experiences
Amadou Moctar Dieye, Direction de la Pharmacie du Médicament, Senegal
• Questions and Answers


11:50– 12:40

SESSION 3: PREVENTION, DETECTION AND CONTROL OF FAKE MEDICINES
• Supply Chain Actors Perspectives
Safiatou Ouattara, Sanofi
Cheikhou Oumar Dia, Conseil national de l'Ordre des Pharmaciens, Sénégal
Abdou Niang, Cheikh Anta Diop University, Senegal
Saer Seck, Association Sénégalaise des Hémodialyses et Insuffisants Rénaux
• Questions and Answers


12:40 – 14:00

LUNCH


14:00 – 14:10

INTRODUCTION BY CO-CHAIRS
Corneille Traore, West African Economic and Monetary Union
Amadou Moctar Dieye, Direction de la Pharmacie du Médicament, Senegal


14:10– 15:45

SESSION 4 : COLLABORATION WITHIN AND BETWEEN COUNTRIES
• Global approach
Mick Deats, World Health Organization
• Role of International Partners - example
Martin Cinnamond, The Global Fund to Fight AIDS, Tuberculosis and Malaria
• Conducive legislative framework to collaboration
Margareth Ndomondo-Sigonda, New Partnership for Africa's Development
Sabine Walser, Council of Europe
• Questions and Answers


15:45 – 16:00

CLOSING BY CO-CHAIRS
Corneille Traore, West African Economic and Monetary Union
Hiiti B. Sillo, Tanzania Food and Drugs Authority
Amadou Moctar Dieye, Direction de la Pharmacie du Médicament, Senegal


MARC GENTILINI

MARC GENTILINI

Fondation Chirac

General Delegate of Fondation Chirac for Access to quality healthcare and medicines, Marc Gentilini is also President of the association OPALS (PanAfrican Organization for the Fight against AIDS) and Honorary President of the French Academy of Medicine. Grand Officer of the Légion of Honor, he has also been President of the French Red Cross from 1997 to 2004.
Professor Marc Gentilini is a well-known specialist of the tropical diseases and has headed from 1970 to 1998 the department of neglected tropical diseases of the Hospital of La Pitié-Salepêtrière (Paris).

CORNEILLE TRAORE

CORNEILLE TRAORE

West African Economic and Monetary Union

Dr Corneille TRAORE obtained a Doctorate in Medicine in 1986, a
Degree in Socioeconomics of Health in 1991, a Master's Degree in
Public Health in 1999 and a PhD in Public Health in 2004.
Current position: Director of Health, Social Protection and Mutual
Insurance of the Commission of the West African Economic
and Monetary Union (WAEMU). In this capacity, he serves as
coordinator of the Secretariat of the Regulatory
Harmonisation and Pharmaceutical Cooperation Unit (CHRCP) of
the WAEMU.
Professional career:
1987-1988 he was a Clinician with the National Hospital of
Ouagadougou; 1988-1990, Chief District Health Officer of
Gourcy;1992-1995, Provincial Health Director in Tougan; 1995-
1997, Head of Cooperation Services of the Department of Studies
and Planning (DEP) at the Ministry of Health; 1998-1999, Director
of DEP; 2003-2004, Manager of Evaluation Monitoring with
the Technical Secretariat of the National Health Development
Plan (ST/PNDS); 2004-2005, Coordinator of the Health System
Decentralisation Support Unit (CADSS); 2006-2007, Programme
Officer, Commission of the WAEMU in Ouagadougou; 2007 to
present: Director of Health, Social Protection and Mutual Insurance
of the Commission of the WAEMU in Ouagadougou
Areas of expertise: public health, epidemiology, health economics,
health systems policy and management, health funding, social
protection, trainer training
Has participated in numerous training programmes and seminars:
e.g. training in the social marketing of drugs, meeting of ECOWAS
experts on drug policy and TRIPS agreements, and meetings
of the French Pharmaceutical Companies Association (LEEM)
Francophone countries on various topics.
Has released a number of works and publications on epidemiology
and health funding in Africa and has supervised numerous student
theses and dissertations.
Member of the Executive Board of the Burkinabe Association of
Public Health (ABSP) and Honorary Member of the Burkinabe
College of Health Economists (CoBES)
Honorary awards: Knight of the National Order of Burkina Faso

JEAN-BAPTISTE NIKIEMA

JEAN-BAPTISTE NIKIEMA

World Health Organization, Regional Office for Africa

Jean-Baptiste Nikiema is regional adviser for Essential
Medicines, EDM (Department of Essential Medicines and
Pharmaceutical Policy), WHO Regional Office for Africa,
Brazzaville, Republic of Congo. He obtained his pharmacy
degree in 1993 from the Free University of Brussels,
Belgium. In 1997 he got a PhD in Pharmaceutical Sciences
from the same University. Back in Burkina Faso, he was
successively lecturer, associate professor and professor
of pharmacognosy at the University of Ouagadougou and
senior researcher at the Annigoni center for Biomolecular
Research (CERBA). He was also engaged with the Ministry
of Health, as the coordinator for antiretroviral drugs at the
National Medicines Regulatory Authority and responsible
for the regulation of traditional medicines since 1998.
Thereafter, he became successively Director of Traditional
Medicine in 2002, Director of the Pharmaceutical
Procurement Department in 2008 and Director General of
the National Medicines Regulatory Authority in 2011. He
also served for four years as chairman of the Board of the
Centre Muraz, an institution specialized in health research
in general and in clinical trials in particular. In 2007, he
established the Ouagadougou International Congress of
Phytotherapy (CIPO). In 2011, he created an international
diploma for the procurement of Pharmaceutical products
related to HIV/aids, Malaria and Tuberculosis, with a focus
on regulation of medical products and the integrity of the
supply chain. He published more than 30 scientific papers
related to innovation starting from medicinal plants, as
well as from biomolecular and pharmaceutical research. In
2012, he joined the WHO Regional Office for Africa.

MARGARETH NDOMONDO-SIGONDA

MARGARETH NDOMONDO-SIGONDA

New Partnership for Africa's Development

Served as Chief Pharmacist (1998), Registrar of Pharmacy Board (1998-2003) and Director General of the Tanzania Food and Drugs Authority (2003- 2010). Joined the African Union - NEPAD Agency as the Pharmaceutical Coordinator (2010-To Date) responsible for coordination of the African Medicines Regulatory harmonization initiative.
Holds MSc degree in pharmaceutical services management, University of Bradford United Kingdom; MBA the Eastern and Southern Africa Management
Institute-Tanzania/ Maastricht School of ManagementNetherlands; and bachelor’s degree in pharmacy from the University of Dar es Salaam, Tanzania.

PATRICK MWESIGYE

PATRICK MWESIGYE

East African Community

Currently a Senior Health Officer at the East African Community Secretariat, responsible for Medicines Regulation Harmonization Project, since 1st July
2013. From September 2009 to June 2013, Head of Pharmaceutical Policy and Medicines Regulatory Body in Republic of Rwanda and Chair of the National Pharmaceutical Establishments Committee. A member of the National Technical Requirements and Specification Committee in Rwanda, and coordinator
for the health commodities committee in Rwanda and including Coordinated Procurement and Distribution
System activities. An Active Member of the EAC Technical team on matters related to food and medicines safety committee, including the various TWGs on MRH from 2009. In addition an inspector
of pharmaceutical establishments in the Republic of Rwanda 2005 – 2009.
He received his B. Pharm from the Tamil Nadu Dr. MGR Medical University Chennai – India April 2003 and his Master’s degree in Clinical Pharmacy from the University of Nairobi, Kenya Dec 2008. In addition,
he has undergone a number of other professional supportive and professional carrier development training progrmmes in Health and related sectors.

EMILIENNE YISSIBI POLA

EMILIENNE YISSIBI POLA

Organization for Cooperation in the Fight against Major Endemic Diseases in Central Africa

Pharmacist with a diploma from the Université Libre de Bruxelles in Belgium Holder of an inter-university
diploma in Public Health: Université de Yaoundé 1, in Cameroon and Université de Montpellier 1, in France Laureate of the Académie Française de la Pharmacie,
Francophone pharmacy award, Winner 2012. Assumed the role of coordinator of the programme on Harmonisation of National Pharmaceutical Policy in Central Africa for several years at OCEAC
(Organisation for Coordination in the Control of Endemic Diseases in Central Africa). Still working as consultant with this organisation for this programme.
Worked in Cameroon in the public service as hospital pharmacist, inspecting pharmacist, head of qualification and drug safety monitoring department,
as well as in the private pharmaceutical sector. Actively contributes to the development and implementation of pharmaceutical policies and
regulations at the national and sub-regional levels. Part-time lecturer and internship tutor at the faculty of
medicine and biomedical sciences, pharmacy section, Université de Yaoundé 1.

BEVERLEY BEDFORD

BEVERLEY BEDFORD

RX360

Ms. Beverley Bedford joined Novartis Africa Cluster in 2013 where she is responsible for implementation
of quality systems throughout the sub-Saharan African region. She is also responsible for assessing distributors throughout 46 African countries and
recommending quality improvements to their systems.
Prior to joining Novartis, Ms. Bedford held the role of QA Director for Johnson & Johnson (Pty) Ltd at their East London factory, she was also the Responsible
Pharmacist for the site. She also held the position of Regulatory Affairs Manager at Pfizer Consumer Health where she was responsible for registration throughout
sub-Saharan Africa. She holds an MBA from Wits Business School and a B.Pharm from the University of Witwatersrand.

CHRISTIAN HAY

CHRISTIAN HAY

GS1

Christian works for over 20 years in the Healthcare industry. He played an instrumental role in the establishment of narcotic control, by using the GS1
system, in Switzerland. In parallel, as from 1995 elements of the GS1 System were deployed for improving accuracy and efficiency of information about the healthcare supply chain, by reducing
administrative costs. Later the TARMED claim programme leveraged the same GS1 identification keys. Christian works for GS1 Switzerland and other GS1 organisations since 2003, focussing on interoperability for IT standards in the healthcare
industry. He currently represents GS1 in organisations such as ISO TC 215 (Health Informatics; since 2012, he chairs the Working Group “Pharmacy” in this Technical Committee), CEN TC 251, HL7 and ICCBBA (transfusion and transplantation). Christian contributes to the board of the Swiss Society for Medical Informatics and was the first chairman for IHE Suisse, which included the rganisation of an European Connectathon in Bern. Christian teaches Healthcare logistics for a
few years at the Bern University of Applied Sciences.
Christian has recently been asked to contribute to the “INTERPOL World” conference, which takes place in
Singapore in April 2015.

AMADOU MOCTAR DIEYE

AMADOU MOCTAR DIEYE

Direction de la Pharmacie du Médicament, Sénéga

Director of Pharmacy and Medicines of Senegal since 2013, Amadou Moctar Dieye is also Professor at Cheikh Anta Diop University in Dakar since 2008. Previously, he held various positions within the Ministry of Health of Senegal and within the Economic and Monetary Union of West Africa (UEMOA). Professor Amadou Moctar Dieye also offers his expertise to learned societies, numerous scientific journals and the Senegalese Army where he holds the rank of Lieutenant Colonel.

CHEIKHOU OUMAR DIA

CHEIKHOU OUMAR DIA

Conseil national de l'Ordre des Pharmaciens, Sénéga

Community pharmacist practicing since 1997, Dr. DIA is board member of the National Council of the Order of Pharmacists of Senegal since 2000. He became its president in 2008. Dr. DIA will complete in May 2016
his second four-year term.

ABDOU NIANG

ABDOU NIANG

Cheikh Anta Diop University

Professor Abdou Niang is a medical specialist in Internal Medicine and Nephrology. He is a certified medical doctor and is a member of the Board of the West African College of Physicians (WACP). He is a former intern at the hospital in Dakar and a former resident physician at the Paris hospitals. He is a full professor at the Medical Faculty of Cheikh Anta Diop University in Dakar, and Deputy Head of the Nephrology-Dialysis Service at University Hospital A. Le Dantec in Dakar where he is responsible for Peritoneal Dialysis. Professor Niang is also the Nephrology consultant at the main hospital in Dakar. He is General Secretary of the Senegalese Society of Nephrology (Soseneph), Assistant General Secretary of the African Association of Nephrology (AFRAN), and member of the African Council of the International Society of Nephrology (ISN).

SAFIATOU OUATTARA

SAFIATOU OUATTARA

Sanofi West Africa

Mrs Nati Safiatou OUATTARA born OUEDRAOGO holds the position of Public Affairs Director of Sanofi West Africa since November 2, 2013.

Safiatou holds a doctorate in pharmacy and a Master’s in Public Health in faculty of Pharmacy of Lille in France .

She is responsible for developing relationships with Sanofi institutional and professional authorities in order to allow Sanofi to be recognized as a key healthcare player in West Africa.

Safiatou has an extensive experience in public health and drug regulation through various positions she held in the Burkina Faso Ministry of Health and the Unit for the harmonization of pharmaceutical regulation and cooperation within the Economic and Monetary Union of West Africa (UEMOA)since 2000.

With this rich experience, she was granted a French Academia of Pharmacy Awards in 2012 for carrying out scientific work for the most part in the 8 French speaking country in West Africa.

MICK DEATS

MICK DEATS

World Health Organization

Michael Deats joined the World Health Organization as project manager for the global surveillance and monitoring system on substandard/ spurious/ falsely labelled/ falsified and counterfeit (SSFFC) medical products in September 2011, and was appointed Group Lead on SSFFC medical products in 2014.

He has responsibility for the design and implementation of the WHO Surveillance and Monitoring System on SSFFC medical products. Since July 2013 the system has been rolled out to 90 Member States, and 18 of the largest procurement agencies. Over 250 regulatory personnel have been trained in the use of the system and over 630 medical products reported to date.

In 2005 he joined the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) as Head of Enforcement with responsibility for 45 intelligence officers, investigators and lawyers handling all serious allegations of non-compliance with medicines regulation and falsified medicines.

He is the author of the first MHRA Anti-Counterfeit Medicine Strategy (2007), the Enforcement Strategy (2010) and the subsequent Falsified Medical Products Strategy (2011)

Whilst with the MHRA he led the investigation and subsequent successful prosecution of the largest counterfeit medicines case in Europe to date (2007-11), some aspects of which have led to the recent changes in European Law (EU, Falsified Medicines Directive)

Whilst with the MHRA he was the originator of the international operation focused on websites illegally supplying medicines now known as Operation Pangea, now in its seventh year involving over 100 Countries, and was a member of the organising committee until joining the WHO.

He was secretary of the European Heads of Medicines Agencies working group of enforcement officers (WGEO) from 2006-2011, and is a member of the Permanent Forum on International Pharmaceutical Crime (PFIPC).

Prior to joining the MHRA Michael was a Police Officer based in London for 30 years, retiring in the rank of Detective Superintendent specialising in the investigation of international organised crime. He was a visiting lecturer at the UK Police Staff College, to the International Command Course.

Michael has travelled extensively with the World Health Organization, Medicines and Healthcare Products Regulatory Agency and Law Enforcement working in over 50 countries.

MARTIN CINNAMOND

MARTIN CINNAMOND

The Global Fund to Fight AIDS, Tuberculosis and Malaria

Martin Cinnamond is the Head of The Global Fund component of the Joint Inter-Agency Task Force (JIATF) a proactive and intelligence-led initiative which focuses on the theft, diversion, and falsification of donor funded anti-malarial medicines. Mr Cinnamond previously worked as an investigator at The World Bank in Washington DC and the United Nations in Afghanistan.

SABINE WALSER

SABINE WALSER

Council of Europe

Sabine WALSER is a pharmacist and holds a doctoral degree in pharmacology and master degrees in toxicology and public health. Since 2002, she works for the Council of Europe, an international political organisation. In her capacity as administrator she coordinates programmes of activities carried out by Member States focused on public health-oriented policy-making in the fields of public health risk management and prevention of counterfeit medicines as well as similar crimes, patient-centred pharmaceutical care, the classification of medicines as prescription or OTC medicines, carried out by expert bodies and overseen by senior officials. Within the above mentioned programmes, the Council of Europe activities against counterfeiting of medicines and similar crimes were launched in 2003 by the former ad hoc group on counterfeit medicines. As co-secretary of the concerned bodies, she facilitated the translation of public health expertise into the drafting of the future Council of Europe Medicrime Convention, an international treaty in the criminal law field. Since 2008, she works for the European Directorate for the Quality of Medicines and Healthcare (EDQM, Council of Europe) and is inter alia contributing to programmes aiming at assisting Member States with the practical implementation of national and international legislation also through networking, intelligence building and training. Since 2007, more than 320 officials from health and law enforcement sectors from more than 45 countries, including certain countries in Africa (Morocco, Angola, Cape Verde, Mozambique, RD Congo, Congo-Brazzaville, Zambia) and South-America, have enrolled in training programmes on how to combat counterfeit medicines and to protect public health, set up within the above-mentioned programmes of activities.

From 1991 to 2001, she held different positions in the pharmaceutical industry, from 1995 to 2001 as Regulatory Affairs Manager Austria and Eastern and Central Europe for a globally operating, research-based pharmaceutical company.

29th Apr 2015

07:30 to 16:00 UTC±00:00

KING FAHD PALACE HOTEL, Pointe des Almadies, Dakar 8181, Senegal

Pour une approche intégrée contre les faux médicaments
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