Writing Successful Pharmacovigilance Risk Management Plans

In association with:

 
Master Class Leaders:
Teresa Cuchi, Founder & Managing Director, Actiomed
&
Alejandro Arana, Partner, Risk Management Resources

OVERVIEW

This Master Class will address some of the key challenges in putting together a Risk Management Plan. It will provide a unique professional insight into areas ranging from routine pharmacovigilance activities, to the evaluation of the effectiveness of the implemented risk management plans.

A risk management system is a set of pharmacovigilance activities and interventions designed to detect, assess, minimise and communicate risks with medicinal products. It may also include assessing the effectiveness of risk minimisation interventions.  A typical medicinal product will have multiple risks associated with it.  Individual risks will vary in terms of severity, effect on the individual patient and impact on public health. Risk management is a continuing process spanning the investigational and marketed lifetime of a medicinal product.

MASTER CLASS LEADERS
 
Teresa Cuchi, Founder & Managing Director, Actiomed

Teresa Cuchi, MD, MPH, PhD is a physician with more than ten years of clinical experience in internal medicine as well as epidemiological research focused on Cancer, Pharmacoepidemiology and Drug Safety. She holds a postgraduate Masters Degree in Public Health and Clinical Epidemiology from Johns Hopkins University.  She has held several positions in the area of pharmacovigilance in pharmaceutical companies in Spain. She has been the European Qualified Person for Pharmacovigilance for several companies at national and international level.  Beyond routine activities such as PSUR production for a wide range of products, she has a vast experience that ranges from preparing Risk Management Plans to process improvement and quality assurance of pharmacovigilance systems.
 
Alejandro Arana, Partner, Risk Management Resources

Alejandro studied Medicine at the University of Zaragoza and specialized in Preventive Medicine with a Masters in Public Health at the Institute of Public Health of Valencia University, and a Masters in Science of Epidemiology at Erasmus University Medical School in Rotterdam.
He has collaborated in several international projects on the epidemiology of aging and dementia both at the University of Zaragoza and Erasmus University. He has also worked as and advisor in Washington DC for the Pan American Health Organization AIDS project in El Salvador.
From 1996, he has worked for several pharmaceutical companies, including Novartis, Pharmacia and Pfizer. He was responsible for conducting several epidemiological projects, mainly in the areas of neurology and the application of epidemiological methods to the quantitative analysis of spontaneous reports.
He collaborates with academia as an invited lecturer in Pharmacoepidemiology and Pharmacovigilance courses (London School of Hygiene and Tropical Medicine, Université St. Antoine, Paris, Universidad de Barcelona).
Alejandro is also a Fellow of the International Society of Pharmacoepidemiology (FISPE), a member of the Board of Directors of the ISPE, co-chair of the Industry council of ISPE, and a member of the working group of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

ABOUT ACTIOMED AND RISK MANAGEMENT RESOURCES

ActioMed is a privately owned, independent, Contract Safety Surveillance Organization (CSO) with extensive experience in pharmacovigilance for the pharmaceutical industry, providing a broad range of services, from operational support in routine pharmacovigilance to audits and organisational review of the system.  Actiomed is UNE-EN ISO 9001:2000 certified.
The professionals working for ActioMed have a solid medical and pharmaceutical background, with a long time experience in monitoring drug safety. 

Risk Management Resources Pharmacovigilance Services is an international organization dedicated to pharmacoepidemiology, drug safety, and risk management activities.
Risk MR has performed numerous epidemiological projects including risk management strategies and plans, risk minimization activities, applications of epidemiological methods to quantitative analysis of spontaneous reports, signal detection prototypes, signal detection throughout product lifecycles, benefit risk modelling, and validity of epidemiology research conducted following good clinical practice guidelines.