SPEAKERS

Nimisha KotechaManaging Director/ EU QPPV

Nimisha has over 20+ years of experience within drug safety and pharmacovigilance having spent a considerable number of years serving as EU QPPV within the Pharmaceutical Industry. Nimisha is the Managing Director of IntuVigilance Limited, a drug safety and PV service provider company serving CROs and Pharma companies, of which The PV Academy forms a subsidiary cohort.

Nimisha KotechaManaging Director/ EU QPPV

Nimisha has over 20+ years of experience within drug safety and pharmacovigilance having spent a considerable number of years serving as EU QPPV within the Pharmaceutical Industry. Nimisha is the Managing Director of IntuVigilance Limited, a drug safety and PV service provider company serving CROs and Pharma companies, of which The PV Academy forms a subsidiary cohort.

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Rym Hadj Kaddour BoukhalfaSenior Pharmacovigilance Specialist

Dr. Rym HK Boukhalfa is a doctor in Pharmacy by profession, in addition she holds a University Diploma in Phamacovigilance and drug safety from the University of Paris Descartes.
Rym has cumulated 7 years experience within Pharmacovigilance and Drug Safety, and provides support to Pharma and National institutions as a Regional PV specialist for the North Africa/French West Africa region. Rym is an expert in Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance agreements at a global level. Rym also has experience with clinical trial application, reporting and product life cycle management.

Rym Hadj Kaddour BoukhalfaSenior Pharmacovigilance Specialist

Dr. Rym HK Boukhalfa is a doctor in Pharmacy by profession, in addition she holds a University Diploma in Phamacovigilance and drug safety from the University of Paris Descartes.
Rym has cumulated 7 years experience within Pharmacovigilance and Drug Safety, and provides support to Pharma and National institutions as a Regional PV specialist for the North Africa/French West Africa region. Rym is an expert in Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance agreements at a global level. Rym also has experience with clinical trial application, reporting and product life cycle management.

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Wangui MathengeChief Executive, PVCC

The PVCC founder, Chief Executive & EAC QPPV, Wangui also known as Coyie Mathenge, is an independent consultant passionate about her company that is committed towards delivering world-class Pharmacovigilance and Drug safety expertise to Pharma & Biotech companies established in Africa with the aim of Keeping patIents Safe & Sound.
Renowned for her inexhaustible levels of energy, enthusiasm and Pharma industry expertise, Coyie is someone who leads by example, cultivating from a wealth of over 12+ years of experience and expertise in safety sciences, Pharma and the healthcare industries both globally & locally.
Coyie holds an MSc degree in Pharmacovigilance and Pharmacoepidemiology from the European Program of Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux, France since 2014 and acquired a BPharm degree from the University of Nairobi. Coyie has been a registered Pharmacist by the Kenya Health Authority since 2009.
Today, Coyie also serves as an executive leader at the International Society of Pharmacovigilance (ISoP)- Africa Charter, an external expert with the European Program of Pharmacovigilance & Pharmacoepidemiology (EU2P program), a guest lecturer to several local universities (promoting Good Pharmacovigilance Practices from an industry’s perspective) and actively promotes Pharmacovigilance best practices with both Pharmaceutical Societies of Kenya & Uganda. Coyie is excited to grow the Pharmacovigilance and Drug Safety expertise in Africa through the Pharmacovigilance Academy.

Wangui MathengeChief Executive, PVCC

The PVCC founder, Chief Executive & EAC QPPV, Wangui also known as Coyie Mathenge, is an independent consultant passionate about her company that is committed towards delivering world-class Pharmacovigilance and Drug safety expertise to Pharma & Biotech companies established in Africa with the aim of Keeping patIents Safe & Sound.
Renowned for her inexhaustible levels of energy, enthusiasm and Pharma industry expertise, Coyie is someone who leads by example, cultivating from a wealth of over 12+ years of experience and expertise in safety sciences, Pharma and the healthcare industries both globally & locally.
Coyie holds an MSc degree in Pharmacovigilance and Pharmacoepidemiology from the European Program of Pharmacovigilance and Pharmacoepidemiology, University of Bordeaux, France since 2014 and acquired a BPharm degree from the University of Nairobi. Coyie has been a registered Pharmacist by the Kenya Health Authority since 2009.
Today, Coyie also serves as an executive leader at the International Society of Pharmacovigilance (ISoP)- Africa Charter, an external expert with the European Program of Pharmacovigilance & Pharmacoepidemiology (EU2P program), a guest lecturer to several local universities (promoting Good Pharmacovigilance Practices from an industry’s perspective) and actively promotes Pharmacovigilance best practices with both Pharmaceutical Societies of Kenya & Uganda. Coyie is excited to grow the Pharmacovigilance and Drug Safety expertise in Africa through the Pharmacovigilance Academy.

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Dr Mouhoudine YerimaNational Pharmacovigilance Head of Togo

Dr. Mouhoudine YERIMA is a doctor in Pharmacy by profession, he holds a MSc degree in pharmacology and medicine related activities, option clinical trials from Paul Sabatier University (Toulouse III), Toulouse-France. Dr. Yerima is responsible for the coordination of Health and Pharmacovigilance programs in Togo. He also has an extensive experience in clinical trials where he endorsed different roles as clinical trial manager/ coordinator of multiple multinational clinical trials.

Dr Mouhoudine YerimaNational Pharmacovigilance Head of Togo

Dr. Mouhoudine YERIMA is a doctor in Pharmacy by profession, he holds a MSc degree in pharmacology and medicine related activities, option clinical trials from Paul Sabatier University (Toulouse III), Toulouse-France. Dr. Yerima is responsible for the coordination of Health and Pharmacovigilance programs in Togo. He also has an extensive experience in clinical trials where he endorsed different roles as clinical trial manager/ coordinator of multiple multinational clinical trials.

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Prof Nadjat Loumi-MededjelHead of the Algerian National Center of Pharmacovigilance and Materiovigilance

Prof. Loumi-Mededjel is the head of the Algerian National Center of Pharmacovigilance and Materiovigilance. She holds a Diploma of Advanced from the Faculty of Medicine of Paris, a University degree in pharmacovigilance from the University Claude Bernard of Lyon and a PhD thesis in clinical pharmacology at the Faculty of Medicine of Besançon. She took part in the creation of the Algerian National Center of Pharmocovigilance and Metriovigilance with its founder the Professor A. Helali in 1998. Pr. Loumi always has been devoted to pharmacovigilance and materiovigilance and since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance.

Professor at the Faculty of Medicine of Algiers, where she teaches the module of pharmacology and supervises the training of resident physicians in clinical pharmacology. She is also an editor of the independent medical journal "Prescrire".

Prof Nadjat Loumi-MededjelHead of the Algerian National Center of Pharmacovigilance and Materiovigilance

Prof. Loumi-Mededjel is the head of the Algerian National Center of Pharmacovigilance and Materiovigilance. She holds a Diploma of Advanced from the Faculty of Medicine of Paris, a University degree in pharmacovigilance from the University Claude Bernard of Lyon and a PhD thesis in clinical pharmacology at the Faculty of Medicine of Besançon. She took part in the creation of the Algerian National Center of Pharmocovigilance and Metriovigilance with its founder the Professor A. Helali in 1998. Pr. Loumi always has been devoted to pharmacovigilance and materiovigilance and since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance.

Professor at the Faculty of Medicine of Algiers, where she teaches the module of pharmacology and supervises the training of resident physicians in clinical pharmacology. She is also an editor of the independent medical journal "Prescrire".

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Hana Manel OudiniQuality Assurance Specialist & Lead Auditor at Novo Nordisk Algeria

Hana holds a Master in Microbiology and Quality Control From University of Science & Technology in Algiers, Algeria. She began her carrier as Quality deputy in the food industry, at Bioche Dorée in Paris, France. In 2014, she joined Novo Nordisk Algeria as Quality Officer and cumulated 6 years’ experience in Good Distribution Practices, Risk Management, Lean implementation and Vendor/Affiliate Audits and became a Specialist in Quality Management Systems in her organisation and a lead auditor.

Hana Manel OudiniQuality Assurance Specialist & Lead Auditor at Novo Nordisk Algeria

Hana holds a Master in Microbiology and Quality Control From University of Science & Technology in Algiers, Algeria. She began her carrier as Quality deputy in the food industry, at Bioche Dorée in Paris, France. In 2014, she joined Novo Nordisk Algeria as Quality Officer and cumulated 6 years’ experience in Good Distribution Practices, Risk Management, Lean implementation and Vendor/Affiliate Audits and became a Specialist in Quality Management Systems in her organisation and a lead auditor.

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Gosia RabakonProject coordinator, Pharmacovigilance Astellas Pharma Europe B.V.

Gosia holds a Master Degree in Health Management with a specialization in Epidemiology from Wageningen University in the Netherlands and additional Post Graduate Diploma in Pharmacovigilance from Hertfordshire University in the UK. She began her career at the European Medicines Agency in the Development and Evaluation of Medicines. Gosia comes from Industry, where she is integral in implementing pharmacovigilance processes such safety variation management and Pharmacovigilance Digital Listening Projects. She is a global expert in Risk Management activities. She also inputs into PVAs, global PSMF and monitors regulatory intelligence in risk management to enable compliance.

Gosia RabakonProject coordinator, Pharmacovigilance Astellas Pharma Europe B.V.

Gosia holds a Master Degree in Health Management with a specialization in Epidemiology from Wageningen University in the Netherlands and additional Post Graduate Diploma in Pharmacovigilance from Hertfordshire University in the UK. She began her career at the European Medicines Agency in the Development and Evaluation of Medicines. Gosia comes from Industry, where she is integral in implementing pharmacovigilance processes such safety variation management and Pharmacovigilance Digital Listening Projects. She is a global expert in Risk Management activities. She also inputs into PVAs, global PSMF and monitors regulatory intelligence in risk management to enable compliance.

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Lydia Brahimi

Graduated from Aix Marseille and Paris XI universities with doctoral studies at Gustave Roussy cancer Institute, she holds a university degree in oncology clinical research and master thesis in oncology pharmacology and therapeutic.
After professional experience in clinical research in France, she joined the 1st active CRO in Algeria where she held different key positions as quality Assurance and Clinical Operations departments head and actively participated to the development and growth of the company.
She cumulated more than 10 years’ experience in clinical research and has always been eager to contribute to the transmission of her knowledge, she is since being active as a consultant specialized in the field.

Lydia Brahimi

Graduated from Aix Marseille and Paris XI universities with doctoral studies at Gustave Roussy cancer Institute, she holds a university degree in oncology clinical research and master thesis in oncology pharmacology and therapeutic.
After professional experience in clinical research in France, she joined the 1st active CRO in Algeria where she held different key positions as quality Assurance and Clinical Operations departments head and actively participated to the development and growth of the company.
She cumulated more than 10 years’ experience in clinical research and has always been eager to contribute to the transmission of her knowledge, she is since being active as a consultant specialized in the field.

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Dr Esther NdambiriHead Office PV Manager, Merck KGaA

Esther Ndambiri is currently the Head Office PV Manager of the Global Patient Safety Organization , Merck KGaA based in Darmstadt, Germany. Prior to this role, she served as the Chief Executive Officer of the Pharmaceutical Society of Kenya (PSK), a professional association for Pharmacists with the mandate to advance Pharmacy practice. She has 10 years’ experience in the pharmaceutical manufacturing sector in both multi-national and locally owned firms in Kenya in various capacities- Quality Assurance, Manufacturing Pharmacist and Regulatory Affairs.
In her current role, she is in the lead in the transformation of the Global Patient Safety organization from being compliance driven to proactively practicing patient safety through a defined risk-based approach. She is managing the change initiative for the Benefit Risk Blue Print Strategy, Risk Based Approach to Data Collection in Patient Support Programs (PSPs) & Patient Data Collection Systems (PDCSs) and PV systems oversight mechanisms.
Esther holds a BPharm from University of Nairobi, MBA in Strategy from USIU-Africa and pursuing a PhD in Health Economics and Policy at University of Lancaster , UK. She is a member of PSK and International Pharmaceutical Federation (FIP).

Dr Esther NdambiriHead Office PV Manager, Merck KGaA

Esther Ndambiri is currently the Head Office PV Manager of the Global Patient Safety Organization , Merck KGaA based in Darmstadt, Germany. Prior to this role, she served as the Chief Executive Officer of the Pharmaceutical Society of Kenya (PSK), a professional association for Pharmacists with the mandate to advance Pharmacy practice. She has 10 years’ experience in the pharmaceutical manufacturing sector in both multi-national and locally owned firms in Kenya in various capacities- Quality Assurance, Manufacturing Pharmacist and Regulatory Affairs.
In her current role, she is in the lead in the transformation of the Global Patient Safety organization from being compliance driven to proactively practicing patient safety through a defined risk-based approach. She is managing the change initiative for the Benefit Risk Blue Print Strategy, Risk Based Approach to Data Collection in Patient Support Programs (PSPs) & Patient Data Collection Systems (PDCSs) and PV systems oversight mechanisms.
Esther holds a BPharm from University of Nairobi, MBA in Strategy from USIU-Africa and pursuing a PhD in Health Economics and Policy at University of Lancaster , UK. She is a member of PSK and International Pharmaceutical Federation (FIP).

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Dr. Kouame Eric KoumenanPharmacist at the Pharmacy, Drug and Laboratory Direction/ Pharmacovigilance and Anti-Illicit Medicines Branch

Dr. Kouame Eric Koumenan is a doctor in Pharmacy by profession, he holds two certifications in Pharmacovigilance and one certification in Clinical trials. Dr. Kouame is currently undertaking a MSc degree in Regulation and Pharmaceutical Inspectorate option Pharmaceutical Inspection from Abidjan University.
 
Dr. Kouame Eric Koumenan is the pharmacist in charge of the Pharmacy, Drug and Laboratory Direction/ Pharmacovigilance and Anti-Illicit Medicines Branch for more than 7 years. Previously, Dr. Kouame was Pharmacist in charge of production at the Pharmaceutical Laboratory of Ivory Coast for 3 years and Pharmacist at Didievi General Hospital for 2 years.

Dr. Kouame Eric KoumenanPharmacist at the Pharmacy, Drug and Laboratory Direction/ Pharmacovigilance and Anti-Illicit Medicines Branch

Dr. Kouame Eric Koumenan is a doctor in Pharmacy by profession, he holds two certifications in Pharmacovigilance and one certification in Clinical trials. Dr. Kouame is currently undertaking a MSc degree in Regulation and Pharmaceutical Inspectorate option Pharmaceutical Inspection from Abidjan University.
 
Dr. Kouame Eric Koumenan is the pharmacist in charge of the Pharmacy, Drug and Laboratory Direction/ Pharmacovigilance and Anti-Illicit Medicines Branch for more than 7 years. Previously, Dr. Kouame was Pharmacist in charge of production at the Pharmaceutical Laboratory of Ivory Coast for 3 years and Pharmacist at Didievi General Hospital for 2 years.

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Frider ChimimbaLecturer in Pharmacovigilance, University of Malawi

Frider is a Lecturer at the University of Malawi. She trained as Pharmacist at the University of Dar-
Es-Salaam, Tanzania and for over twenty years worked with different organisations in community pharmacy. In 2006, she obtained an Msc in Pharmaceutical Services and Medicines Control at the University of Bradford UK, followed by MSc Clinical Research at Cranfield University UK in 2013. She then joined University of Malawi, College of Medicine as a lecturer in Pharmacovigilance and Pharmacy Practice. In 2015, she was one of the key persons involved in setting up the National Pharmacovigilance Centre in collaboration with the National Regulatory Authority. With a small team of four Pharmacists, they successfully managed to meet the requirements for Malawi to
become a full member of the WHO International Drug Safety Monitoring Programme in March 2019. She is also involved in research work focusing on PV related baseline studies and drug utilization studies. From 2016, she has been involved in the project titled “Strengthening PV in Malawi” in collaboration with GSK and conducting nationwide training of post service healthcare workers on Pharmacovigilance under Global fund. Frider has also been actively involved in the Malaria Vaccine implementation project, participating in the initial planning of the Malaria vaccine roll out in selected districts, drafting national guidelines on Adverse Effects Following Immunization (AEFI) together with WHO experts and training staff on general and vaccine PV. She has served in several committees of the national regulatory authority and is currently a member of the Medicines Safety Committee of the same. Future projects include PV curriculum development for all health care training institutions in Malawi and establishing a CRO within the Pharmacy department at College of Medicine.

Frider ChimimbaLecturer in Pharmacovigilance, University of Malawi

Frider is a Lecturer at the University of Malawi. She trained as Pharmacist at the University of Dar-
Es-Salaam, Tanzania and for over twenty years worked with different organisations in community pharmacy. In 2006, she obtained an Msc in Pharmaceutical Services and Medicines Control at the University of Bradford UK, followed by MSc Clinical Research at Cranfield University UK in 2013. She then joined University of Malawi, College of Medicine as a lecturer in Pharmacovigilance and Pharmacy Practice. In 2015, she was one of the key persons involved in setting up the National Pharmacovigilance Centre in collaboration with the National Regulatory Authority. With a small team of four Pharmacists, they successfully managed to meet the requirements for Malawi to
become a full member of the WHO International Drug Safety Monitoring Programme in March 2019. She is also involved in research work focusing on PV related baseline studies and drug utilization studies. From 2016, she has been involved in the project titled “Strengthening PV in Malawi” in collaboration with GSK and conducting nationwide training of post service healthcare workers on Pharmacovigilance under Global fund. Frider has also been actively involved in the Malaria Vaccine implementation project, participating in the initial planning of the Malaria vaccine roll out in selected districts, drafting national guidelines on Adverse Effects Following Immunization (AEFI) together with WHO experts and training staff on general and vaccine PV. She has served in several committees of the national regulatory authority and is currently a member of the Medicines Safety Committee of the same. Future projects include PV curriculum development for all health care training institutions in Malawi and establishing a CRO within the Pharmacy department at College of Medicine.

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Course Fees

Early Bird (Pharmaceutical industry): €400.00

Early Bird (Healthcare / Academic): €300.00

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  • Refreshment & Lunch

    Are the meals included?
    All refreshments and lunches have been carefully selected to offer you a quality catered service. If you have any dietary restrictions that we may address to make your participation at our events more enjoyable, please do let us know when registering. If you have requested a special diet, please check with staff at the Registration desk when you arrive.

  • What about accommodation?

    The cost of the hotel accommodation and travel is not included in the registration fee.

  • How and when can I pay for the course?

    All delegates must register and pay in advance of the course; the place is confirmed once the payment is processed successfully. If you wish to pay via bank transfer then please contact info@intuvigilance.com

  • Will there be CPD credits and Certificate of Attendance?

    The course has been approved for professional CPD credits. A Certificate of Attendance, showing CPD will be given out at the end of the course

  • Cancellation Policy

    Cancellations must be received in writing at least two weeks before the start of the event and will be subject to an administration charge of 20% of the course fee. It is regretted that no refunds will be made within two weeks of the course date.

Venue Details