Workshop: Drug Safety, Probabilistic Causal Assessment, and Evidence Synthesis (27-28 Jan, 2017, LMU, Munich)

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Bennett Holman
Jürgen Landes
Barbara Osimani
Roland Poellinger
David Teira


The latest regulatory amendments concerning pharmacovigilance practice made by the European Parliament and the European Council (Directive 2010/84/EU; Regulation (EU) No 1235/2010) put a special emphasis on joint efforts to develop an integrative information-based approach to pharmaceutical risk assessment. The related guidelines encourage the amalgamation of information from different sources (e.g. spontaneous case reports, literature, data-mining, pharmacoepidemiological studies, post-marketing trials, drug utilization studies, non-clinical studies, late-breaking information). Yet, the methodological bases for implementing such a policy are shaky in that causal assessment of adverse drug reactions still relies mainly on the (statistical) methods developed to test drug efficacy.

Philosophers have developed a variety of tools to address methodological and epistemological issues that arise in causal assessment in medicine. This research program interacts with the work of health professionals, methodologists, statisticians and epidemiologists. Moreover, social epistemology and decision-theoretic tools are increasingly acknowledged as useful instruments to model research dynamics, knowledge flux and evaluate funding policies. Since medical research and clinical practice are pervaded by all sorts of conflicts of interest, there is room for implementing these approaches to understand the way medical knowledge works in our social world.

This workshop aims to provide a platform allowing scholars and decision makers to focus on causal assessment for the purposes of drug safety. In particular, the following topics, among others, will be explored and investigated: limits and potential of standard methods for evidence synthesis (meta-analysis, systematic review), mixed methods, machine learning and spontaneous reporting, safety pharmacology, systems pharmacology, evidence based medicine versus pluralistic approaches to evidence evaluation, and social epistemology in pharmacology. In addition, the workshop is intended to foster novel approaches to risk management and decision making.

Date and Location

It will took place on Friday the 27th of January 2017 and Saturday the 28th of January 2017 at LMU in Munich.

Speakers, Schedule, and Further Information

Please visit the workshop’s website at for details about speakers, schedule, venue, accommodation, and travel issues:


Rani Lill Anjum and Elena Rocca

Jon Williamson slides

Felipe Romero and Jan Sprenger

Barbara Osimani slides

Jeff Aronson slides

Ralph Edwards

Mike Kelly slides

Ulrich Mannsmann

Brigitte Keller-Stanislawski slides

Beth Shaw

Stephen Senn slides

Norbert Benda

Stephen Mumford

Adam La Caze slides

Jacob Stegenga

Roland Poellinger slides

Jürgen Landes slides

Martin Posch and Franz König slides

David Teira slides

Bennett Holman







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