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PROTECT Symposium

In this section you will find all presentations given at the PROTECT Symposium, which was held at the European Medicines Agency in London, on the 18-19-20 February 2015.

Also, recordings from the event, which are available at the EMA YouTube Channel, can be accessed through the links below.

Finally, a list of participants is available at the bottom of the page.




PROTECT Symposium_18-20 Feb 2015_programme





PROTECT pre-Symposium Training Sessions - 18/02/2015 (20 videos)

PROTECT Symposium day 1 and 2- 19-20/02/2015 (28 videos)





1. Training Session Benefit-Risk Assessment: Concepts and Methods

1.1 Benefit-Risk Integration and Representation

1.2 Patient Preferences


2. Training session Application of MCDA to real-life decision-making

2.1 Overview of multicriteria and statistical methods applied to regulatory decisions


3. Training Session Statistical Signal Detection

3.1 Signal Detection in Practice-EMA

3.2 Statistical signal detection - UMC

3.3 Signal detection in practice - Company perspective

3.4 Introduction to disproportionality analysis

3.5 Pitfalls of disproportionality analysis

3.6 Empirical Evaluation

3.7 Signal detection in Clinical trials


4. Methods to control for confounding

4.1 Introduction: overview of methods to control for confounding

4.2 Control for unmeasured confounding

4.3 Control for time-dependent confounding



5. Symposium Day1 (19/02/2015)


Sessions 1,2,3 :

1. Opening 2. The place of PROTECT in Regulatory Science 3. Shaping objectives into a work programme


Session 4: Signal detection

4.1_Introduction to PROTECT research and recommendations

4.2_Use of ontologies in signal detection

4.3_Statistical signal detection for spontaneous reports

4.4_Signal detection from clinical trials

4.5_Signal detection in electronic medical records


Session 5: Improving consistency between pharmacoepidemiological studies

5.1_Objectives and methods

5.2_Outcomes of studies for six adverse event-drug pairs and five databases: what did we learn?

5.3_Replication of studies based on a common protocol

5.4_Comparison of methods to control for confounding: review of findings and lessons

5.5_Measuring the public health impact of adverse drug reactions

5.6_A Canadian initiative: CNODES

5.7_US initiatives: OMOP and Mini-sentinel


6. Symposium Day2 (20/02/2015)


Session 6: Pilot study of Direct-to-Patient pharmacovigilance

6.1 Background and objectives of the PROTECT Pregnancy Study


Session 7: Benefit-risk integration and representation

7.1 Recommendations of the PROTECT Benefit-Risk

7.2 Benefit-risk assessment a real-life experience

7.3 In sickness and in health and for the greater good

7.4 Patients understanding of benefits and risks

7.5 Panel discussion the past, the present and the future


Session 8: Review of experience and lessons learnt

8.1 Contribution from PROTECT to regulatory practice

8.2 The Innovative Medicines Initiative lessons learnt



PROTECT Symposium List of participants