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DRUG SAFETY IN THE LICENSING OF MEDICINES
One-day conference to be held at The Centre for Evidence-Based
Pharmacotherapy, Aston University, Birmingham, UK. 4 November 1999
Aims and Objectives
This conference will focus on drug safety assessment in the licensing
of medicines and the emerging issue of costing of adverse drug
reactions. A major feature of this meeting will be the case
discussions to illustrate some of the problems highlighted in the
lectures. The aim is for participants to have a clearer understanding
of regulatory issues in the safety assessment of medicines.
Target audience
The meeting should be of interest to all those concerned with
evaluating adverse drug reactions. It should have particular appeal to
those interested in the licensing and marketing of medicines. Those
undertaking risk-benefit and cost-effectiveness analyses of medicines
should also find the course of value.
Course format
For the first part of the programme the meeting will adopt the
traditional format of lectures, followed by discussions. The second
part of the programme will follow a more interactive mode. Advanced
documentation will be sent to all participants.
Venue
Centre for Evidence-Based Pharmacotherapy
Aston University
Aston Triangle
Birmingham B4 7ET
Programme
Introduction and welcome (09.30 - 09.40 hrs)
Professor Alain Li Wan Po, Aston University
Drug safety in the licensing of medicines (09.40 - 10.10 hrs)
Professor Martin Kendall, Brimingham University
Coffee Break (10.10 - 10.40 hrs)
Drug safety monitoring: the European dimension (10.40 - 11.00 hrs)
Dr Patrick Waller, Medicines Control Agency
Discussion (11.00 - 11.30 hrs)
Yellow cards and black triangles: Do they tell us anything? (11.30 -12.00 hrs)
Dr Ennis Lee, Medicines Control Agency
Drug interactions: looking into the liver (12.00 - 12.30 hrs)
Dr Munir Pirmohammed, University of Liverpool
Lunch (12.30 - 13.30 hrs)
The economic implications of adverse drug reactions: from
pharmacoepidemiology to pharmacoeconomic modelling (13.30 - 14.00
hrs)
Professor Alain Li Wan Po, Aston University
Post-marketing drug surveillance: systems, signals and noises (14.00
-14.30 hrs)
Dr Robin Ferner West Midlands Adverse Drug Reactions Centre
Coffee break (14.30 - 15.00 hrs)
Case study: Pancreatic enzymes and fibrosing colonopathy (15.00
-15.40 hrs)
Case study: Non-steroidal anti-inflammatory agents (15.40 - 16.20
hrs)
Discussion and Conclusion (16.20 - 16.45 hrs)
End of meeting (16.45 hrs)
About the speakers
Professor Martin Kendall is Associate Dean at the University of
Birmingham Medical School. He is Chairman of the Subcommittee on Drug
Safety of the Committee on Safety of Medicines.
Dr Robin Ferner is Director of the West Midlands Adverse Drug
Reactions Reporting Centre and Chairman of the Board of Management of
the Prescribers' Journal.
Dr Ennis Lee is Principal Assessor, Pharmacovigilance, at the
Medicines Control Agency.
Professor Alain Li Wan Po is Director of the Centre for Evidence-Based
Pharmacotherapy at Aston University and past member of the Committee
on Safety of Medicines and of its Sub-committee on Chemistry, Pharmacy
and Standards.
Dr Munir Pirmohammed is Senior lecturer in the Department of
Pharmacology and Therapeutics at the University of Liverpool and a
member of the Committee on Safety of Medicines
Dr Patrick Waller is a specialist in Pharmacovigilance, Post-Licensing
Division of the Medicines Control Agency
An application form can be obtained from Mrs Sylvia Rowe at
[log in to unmask] or from our website
http://www.aston.ac.uk/pharmacy/cebp
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Dr. W Y Zhang
Centre for Evidence-Based Pharmacotherapy
Department of Pharmaceutical Sciences
Aston University
Aston Triangle
Birmingham B4 7ET
UK
Tel: +44 (0)121 359 3611 x5535
Fax: +44 (0)121 359 0733
Email: [log in to unmask]
http://www.aston.ac.uk/pharmacy/cebp/
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