Upcoming Seminars

Basel Epidemiology Seminar on

Pregnancy Research

Date and time:

March 20th, 2020

13:00-16:00

 

Venue:

Novartis Pharma AG

Auditorium U2, Fabrikstr. 6 (Visitor Center)

Novartis Campus, Basel

 

Registration:

  • Free of charge
  • Please register until March 13th here:
  • (We kindly request also Novartis associates to register for the event.)
  • Visitor badges shall be picked up at the main gate, latest 15 min prior to start of the seminar.

Agenda

13:00 – 13:15         Conny Berlin (Novartis, Basel)

Welcome & Introduction

13:15 – 13:45         Julia Spöndlin (University Basel)

Building a mother-baby cohort using Swiss claims data

 13:45 – 14:15         Tania Schink (BIPS, Bremen)

Establishment of a framework to study the utilization and safety of drugs during pregnancy in the German Pharmacoepidemiology Research Database (GePaRD)

 14:15 – 14:30         Break 

14:30 – 15:00         Kiliana Suzart-Woischnik (Bayer, Berlin)

Experience from the Betaferon pregnancy registry

 15:00 – 15:30         Lisa Prach (Novartis, Basel)

Evolving strategies to address health authority requests in reproductive toxicity: an industry perspective

 15:30 – 16:00         Panel discussion


Abstracts and speaker’s bio:

Julia Spoendlin is a trained pharmacist and pharmacoepidemiologist working at the Basel Pharmacoepidemiology Unit (BPU) at the Universtiy of Basel and the University Hospital Basel. She completed her doctoral thesis in pharmacoepidemiology and a training in clinical pharmacy in Basel at the BPU in 2013, where she also worked as a postdoctoral researcher for 2 years after. Between 2016 and 2018 she joined the Division of Pharmacoepidemiology at the Brigham and Womens Hospital in Boston for a 2-year postdoctoral fellowship. During this time she also completed a Master in Publich Health.

In her talk at the BES, Julia will talk about the current progress and future goals in the establishment of a mother-baby cohort using Swiss claims data (the Swiss MOBA) to evaluate drug use and safety during pregnancy in Switzerland. This project has been initiated in 2019 in collboration with the Department of Health Sciences at the Swiss health insurance Helsana as well as with the unité médicaments en vie réelle at the centre hospitalier universitaire vaudois (CHUV). It aims to fill the information vacuum around drug utilization during pregnancy in Switzerland. The presentation will focus on the technical aspects of builiding the Swiss MOBA using Swiss claims data as well as on an evaluation of the use of antiseizure drugs during pregnancy in Switzerland.

 

Tania Schink is a statistician and pharmacoepidemiologist and the head of the drug safety unit at the Leibniz Institute for Prevention Research and Epidemiology – BIPS in Bremen, Germany. She has more than 10 years of experience in pharmacoepidemiology, working on EU funded multi-database studies, Post Authorization Safety Studies, and research projects regarding the use and safety of drugs in vulnerable populations such as the elderly and pregnant women.

In her talk at the BES, she will detail the preparatory work that is needed to be able to study utilization and safety of drugs during pregnancy based on claims data: 1. Identification of pregnancies and the classification of their outcomes (e.g. livebirth, stillbirth, induced abortion). 2. Development of an algorithm to estimate the beginning of pregnancy / gestational age. 3. Establishment of a procedure to link newborns with their mothers.

 

Kiliana Suzart-Woischnig (to be added).

 

Lisa Prach has been an Epidemiologist in the Quantitative Safety and Epidemiology department at Novartis since June 2019. She completed her PhD in Molecular and Cell Biology and Master in Public Health from the University of California Berkeley (UCB). She lead several studies at UCB and the University of California San Francisco, working on primary data collection and secondary data use in observational research related to infectious diseases and maternal and child health. She also worked at the California Department of Public Health on newborn screening surveillance for cystic fibrosis. She currently leads the scientific aspects of the Gilenya Pregnancy Registry for Novartis.

In her talk at the BES, Lisa will describe the evolving strategies Novartis has developed and proposed to robustly address health authority requests regarding issues of reproductive toxicity. She’ll generally describe past experiences and challenges as well as highlight new strategies under development. Her talk will touch briefly on pregnancy registries, enhanced pharmacovigilance in pregnancy, and secondary (claims) database use as complementary strategies to assess drug safety in pregnancy.

 

Downloads

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Download Presentation: Christian Schindler                                                           BES 2018 Christian Schindler_Overview of statistical methods

Download Presentation: Audrey Muller                                                                     BES 2018 Audrey Muller_Comparative effectiveness in rare disease

Download Presentation: Gracy Crane                                                                          BES 2018 Gracy Crane_Comparative effectiveness of patients

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Download Presentation: Prof. Dr. Christoph R. Meier BES_Benzos_Dementia_Meier_23.06.2017

Download Presentation: Anna Beckmeyer-Borówko, PhD, MBA BES_Beckmeyer_Borowko_Population_based_studies

Download Presentation: S. Behr & D. Rosenberg                           BES_Assessing-long-term-latencies-for-newly-marketed-drugs

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Seminar: “Propensity Score Methods for Causal Inference? “

Download Presentation: Julia Spoendlin

BES-2018-Introduction to Propensity Score Methods_Julia Spoendlin_17.08.2018

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BES-2018-Causal Inference DAGs_Giusi_Moffa

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BES-2018-Alexander Michel- Propensity Scores

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BES_Sigrid Behr _For-causal-inference-rare-outcomes

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Seminar: “Patient Preferences – methods and relevance for medicinal decision making”

Download Presentation: Conny Berlin

1_BES_BBS Seminar 22Nov2018_Introduction PP_CBerlin

Download Presentation: Stuart Osborne

2_BBS_BES Seminar 22Nov2018_PrefMab_RochePDMABiometrics_StuartOsborne_22Nov2018Final

Download Presentation: Evan Davies 

3_BBS_BES Seminar 22Nov2018_Evan Davies

Download Presentation: Florian Gutzwiller

4_BBS_BES Seminar 22Nov2018_FGutzwiller_GMCC

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Satellite Seminar on Causal Inference

Download Part 1 Introduction to Causal Inference and directed acyclic graphs EMD:

BES 5_July_2019 part 1 Introduction to Causal Inference and directed acyclic graphs EMD

Download Part 2 DAG to identify covariates to adjust for confounding Final GDP:

BES 5_July_2019 part 2 DAG to identify covariates to adjust for confounding Final GDP

Download BES 5_July_2019 part 2  sim_data GDP: (.XLSX)

BES 5_July_2019 part 2 sim_data GDP