Day two

last modified: 17 September '12

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8am

Breakfast seminar Hosted by Synowledge: Partnering for Success

8.55am

Opening remarks from the Chair

Dr Shirish Sherlekar

Dr Shirish D Sherlekar is a trained doctor by profession. He has worked for five years at the P.D. Hinduja Hospital and Research centre as a resident surgeon and the Hospital of the Kaiga atomic power plant as a Medical director before shifting to...

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› Dr Shirish Sherlekar, Global head life sciences practice, Tata Consultancy Services

9am

Keynote: Benefit risk in the changing PV environment

Michael Richardson

Michael Richardson has over 25 years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and...

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› Michael Richardson, Vice President, International Pharmacovigilance and EU QPPV, BMS

9.20am

The operational challenges for implementing benefit risk

Sue Rees

Sue is currently the Head of Pharmacovigilance & Medical Information and acts as EU QPPV for Eisai Europe Ltd. In this role Sue heads up a team of scientists and physicians responsible for all aspects of global safety for Eisai’s oncology and GI...

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› Sue Rees, Head of Pharmacovigilance and Medical Information and EU QPPV, Eisai

9.40am

Evaluating the effectiveness of risk minimisation

Michael Forstner

Dr. Michael Forstner is “Integrated Safety Risk Manager” at F. Hoffmann-La Roche in Basel. In this role his main duties are to develop and implement processes for the coherent and consistent global management of drug safety risks together with his...

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› Michael Forstner, Process Development Leader; Chair Risk Management WG, f.Hoffmann La Roche

10.10am

Refreshments

10.50am

In conversation: Evaluating the effectiveness of risk minimisation and the role of clinical stakeholders in this practice

Michael Forstner

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› Michael Forstner, Process Development Leader; Chair Risk Management WG, f.Hoffmann La Roche

11.40am

Quality of ICSR Impacting Signal Detection

Dr Pavan Badale

Pavan Badale has over 6 years of total work experience; in various areas of ICSR as a case processing training, Drug Safety physician, Lead PV Physician, Subject Matter Expert and currently working as a Group lead for a Pharmacovigilance project. ...

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› Dr Pavan Badale, Group Leader and Subject Matter Expert ICSR Pharmacovigilance, Tata Consultancy Services

12.10pm

The role of pharmacoepidemiology in drug safety

Dr. Mirza I Rahman

Dr. Rahman is currently a Senior Director & Clinical Risk Management Group Leader in the Global Safety Department at Merck & Co., Inc. He is also a practicing physician at the Concentra Occupational Medicine & Urgent Care Medical Centers, and is a...

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› Dr. Mirza I Rahman, Senior Director, Pharmacovigilance, Merck

12.40pm

Lunch

1.50pm

Keynote: Challenges and Solutions for consistent global pharmacovigilance

Stewart Geary

E. Stewart Geary, M.D, has worked at Eisai since 1996 in pharmacovigilance, clinical safety and regulatory science. He is currently a member of the CIOMS IX Working Group on Medicinal Product Risk Management, the Executive Committees of the Japanese ...

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› Stewart Geary, Vice President, Global Safety Officer, Eisai

2.20pm

Practical procedures for implementation of the E2B(R3) standard

Alastair G Fowkes

Alastair Fowkes has over 20 years experience in pharmacovigilance and has worked extensively in the area of safety systems for the last 10. He has worked on or led three safety system implementation projects and two ICH E2B implementation...

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› Alastair G Fowkes, Associate Director, AstraZeneca

2.40pm

Afternoon refreshments

3.10pm

PANEL– Improving oversight and management of global safety operations

Zsuzsanna Mueller

Zsuzsanna studied Nutritional Sciences at the University of Vienna. She worked at Abbott for 5 years as Scientific Manager Nutrition and Quality Assurance Manager, before changing to Intercell, where she supported the development of the...

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Gloria Bustos

Gloria Bustos is PhD in Pharmacy by the University of Valencia, Spain. Since 2006 she is Pharmacovigilance Director for Baxter HealthCare Corporation in charge of Southern Europe. She is responsible for direction of Pharmacovigilance function in the ...

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Pentti Timonen at World Drug Safety Congress Europe

› Zsuzsanna Mueller, Senior Manager Pharmacovigilance, Clinical & Medical Affairs, Intercell
› Gloria Bustos, Director Pharmacovigilance Southern Europe EMEA SDEA Coordinator, Baxter
› Pentti Timonen, Senior Director Pharmacovigilance, Crucell B.V.

3.30pm

Pharmacovigilance quality assurance, auditing strategies

Celestina Arrigo

Celestina Arrigo has a PhD in Public Health and Masters in Epidemiology and Management gained at the Free University in Brussels. Celestina has over 25 years experience in Clinical Research, Epidemiology, Pharmacoepidemiology and Health Economics...

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› Celestina Arrigo, Senior Director, Pharmacovigilance Data Quality Expert, UCB

3.50pm

Implications of the new EU Pharmacovigilance legislations on the role of quality assurance:

Amer Alghabban

Amer completed his M.Sc in Pharmacology at Bradford University, Postgraduate studies in Medical Sciences at University College Hospital, Diploma in Biological Sciences from Salford University and Postgraduate Certificate in Clinical Research from...

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› Amer Alghabban, Head of GCP Auditing Group, Merck Serono

4.10pm

Closing summary: Discussion for World Drug Safety Congress 2012

Doris Stenver

Education- 1986 Medical Degree from Copenhagen University, the Faculty of Medicine 2007 Master Degree in Public Administration, Copenhagen Business School. Clinical Experience- During 12 years (1986-1998) she worked at university hospitals in the...

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