Tuesday 7 and Wednesday 8 December 2010, Miami, Florida, USA

Tell a Friend | FAQs | Site Map

Home : Program : Pre-Conference Workshop

2009 Pre-Conference Workshop

Tuesday 3 March 2009

Day 1
Day 2
Pre-Workshop

Practical epidemiology usage for effective RMPs

Date:

Tuesday 3 March 2009

Led by:

Alejandro Arana
Director
Risk Management Resources

Felix Arellano
Partner
Risk Management Resources

About the Worshop:

A risk management system is a set of Mobile Financial Services Congress activities and interventions designed to detect, assess, minimise and communicate risks with medicinal products. The use of epidemiology is needed in each of the activities proposed. The section on the epidemiology of the indication should attempt to define the likely level of use and characteristics of users of the product, and address the populations potentially at-risk (where the product is likely to be used). Analytic epidemiology is used to define outstanding safety questions which warrant further investigation to refine understanding of the benefit-risk profile during the post-authorisation period.

Workshop agenda

09:00

Registration and coffee

09:30

SESSION 1:

Epidemiology of the indication
Epidemiology of the identified and potential risks
Use of epidemiological studies for risk assessment

11:00

Refreshments

11:30

SESSION 2:

Use of epidemiological studies for risk management activities (RMA) evaluation
Use of epidemiology for effective communication with health authorities and patients
Training internal staff

13:00

Close of workshop

About your workshop leaders:

Felix M Arellano

Felix M Arellano is a physician with a specialty in clinical pharmacology and a co-founder of Risk Management Resources. He was trained in pharmacoepidemiology in McGill University and is a Fellow of the International Society for Pharmacoepidemiology, Switzerland. Felix has held several positions in the areas of Mobile Financial Services Congress and pharmacoepidemiology in pharmaceutical companies in Europe and the USA. He is currently serving his second elected term as a member of the Board of Directors of the International Society for Pharmacoepidemiology. Before founding RMR, he was the Chief Safety Officer at Pharmacia Corporation. www.riskmr.com

Alejandro Arana

Alejandro Arana studied medicine at the University of Zaragoza and specialised in Preventive Medicine He collaborated on the epidemiology of ageng and dementia at the University of Zaragoza and Erasmus University, and as advisor in Washington DC (US) for the Pan American Health Organization AIDS project in El Salvador. From 1996 he worked for several pharmaceutical companies; Novartis, Pharmacia and Pfizer. He is Fellow of the International Society of Pharmacoepidemiology (FISPE), member of the Board of Directors of the ISPE, and co-chair of the Industry council of ISPE. www.riskmr.com