Regulatory News

10th April 2012

by Alexander Gaffney, RAC

EMA Holds Workshop on Use of Medicines in the Elderly

The European Medicines Agency (EMA) held a two-day workshop in March 2012 on the use of medicines in older persons.

The workshop saw 34 presentations covering a wide range of perspectives on the subject, including EMA's geriatric strategy, conducting clinical trials, pharmacovigilance, ensuring safety and efficacy of medicines through modeling and more.

Those presentations may be found in the links below.

European Medicines Agency workshop on medicines for older people

European Medicines Agency workshop on medicines for older people - Invitation for expressions of interest

Programme - European Medicines Agency workshop: Ensuring safe and effective medicines for an ageing population

Presentation - EMA Geriatric medicines strategy, Francesca Cerreta

Presentation - Healthy ageing and medicines the patients perspective of ageing, Barbro Westerholm

Presentation - The industrys views on geriatric medicines, Jean-Pierre Lehner

Presentation - ICH E7 requirements and how they are translated in practice, Kristina Dunder

Presentation - Elderly patients and clinical trials, Bertil Jonsson

Presentation - Can PK and modelling help?, Terry Shepard

Presentation - Modelling and simulation to support evaluation of safety and efficacy of drugs in older patients, Eva Bredberg

Presentation - How to get better data on medicines post licensing, Thomas MacDonald

Presentation - Endpoints and their relevance to older people: cancer and palliative care and work of EORTC, Ulrich Wedding

Presentation - Endpoints and indications for the older population, William Evans

Presentation - Frailty: Challenges and possible solutions, Niccolo Marchionni

Presentation - The cluster medicine approach, Alessandra Marengoni

Presentation - The industrys views on "older" old patients, Susanna Del Signore and Philippe Guillet

Presentation - Increasing enrolment in clinical trials and the PREDICT study, Antonio Cherubini

Presentation - Efficacy and effectiveness models, Graziano Onder

Presentation - Proposal for guidance on medical research for and with older people in Europe, Florian Von Raison

Presentation - Practical proposals on recruitment improvement: R&D approach and focus on possible bottleneck issues, Brigitte Stemper

Presentation - Medication Errors & STOPP/START criteria, Denis O'Mahony

Presentation - Predictors of outcome and renal clearance, Ulf Bergman

Presentation - Pharmacovigilance and the elderly, Dolores Montero

Presentation - EudraVigilance and signal detection, Georgy Genov

Presentation - Industry perspective, Michael Richardson

Presentation - Pharmacovigilance in the elderly: Conclusions, Peter Arlett

Presentation - Formulations, packaging and medication practices considerations, Michael J. Theodorakis and Adalsteinn Gudmundsson

Presentation - Industry perspective on formulation and packaging considerations, Ronald Ogilvie

Presentation - What do we need to consider to ensure medication adherence of older adults, Sven Stegemann

Presentation - Providing information to the older population - Understanding the needs of older people, Jean-Pierre Baeyens

Presentation - A NCA analysis of approval documents, Paul Jansen

Presentation - How can SmPC and EPAR information contribute to the safe and effective use of medicines in older population?, Laurent Brassart

Presentation - Package leaflet initiatives, Alexios Skarlatos

Presentation - Providing information to the older population, an industry perspective, Lisette Vromans

Presentation - Conclusions, Tomas Salmonson, June Raine

Return to listing