ConcePTION has spent 5 years working to set up an ecosystem for pharmacovigilance in pregnancy and breastfeeding. LIFESAVER is just getting started on their journey towards advancing risk assessment for drugs and chemicals in pregnancy. Together, we work to fill the knowledge gaps. On 14 May, we share what we do, and how we complement each other in a joint webinar. Save the date!
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Preliminary agenda
13:30-13:40 Welcome and introduction – Michael Gasik & Miriam Sturkenboom
13:40-14:40 Session 1: Introducing ConcePTION & LIFESAVER
13:40-14:00 Building an ecosystem for medicine safety in pregnancy & breastfeeding – Miriam Sturkenboom & Marjolein Willemen
14:00-14:10 Q&A
14:10-14:30 Advancing risk assessment for drugs and chemicals in pregnancy – Michael Gasik
14:30-14:40 Q&A
14:40-15:40 Session 2: Sharing results
14:40-15:00 Setting up a lactation network: approaches, results and lessons learnt – Pieter Annaert
15:00-15:10 Q&A
15:10-15:30 Risk assessment, mitigation measures and regulation improvement for a safer pregnancy and healthier newborns – Thomas Zadrozny
15:30-15:40 Q&A
15:40-16:20 Session 3: Panel discussion on realising impact – Moderated by Jasper Levink
16:20-16:30 Closing – Michael Gasik & Miriam Sturkenboom
Speakers
Michael Gasik
Michael Gasik is the Chairman and co-founder of Seqvera Ltd. Oy (Helsinki, Finland) and the Ambassador (Finland) of the European Orthopaedic Research Society (EORS). He is a Full Professor at Aalto University Foundation (Espoo, Finland) and has held visiting professorships in the UK, Japan, Italy, Portugal, and Estonia. With over 300 publications and patents spanning 30 years, he has led numerous EU, IEA, and national projects. Michael was appointed EORS Ambassador for Finland in 2020 and has served in various international committees and organizations, including COST Actions and the European Connected Health Alliance (ECHA). He specializes in developing innovative in vitro testing methods and owns the LinkedIn group ‘Advanced Testing of Biomaterials’. Michael founded Seqvera Ltd. (www.seqvera.com) in 2016, focusing on biomaterials, medical devices, and advanced therapy medicinal products (ATMP) development in compliance with regulations like MDR 2017/745 and IVMDR 2017/746.
Miriam Sturkenboom
Miriam Sturkenboom, PhD (cum laude), is the head of the Department of Data Science and Biostatistics at the Julius Center, University Medical Center Utrecht, Netherlands. She holds a pharmacy degree and a Master’s in Epidemiology from Harvard School of Public Health. Previously, she was a professor at Erasmus MC and is currently a professor of Real World Evidence at UMC Utrecht. Her research focuses on real-world data transformation into evidence on drug use, effectiveness, and safety in vulnerable populations. She leads international projects funded by the European Commission, IMI, and other organizations. Notably, she coordinated the IMI-funded ADVANCE project and now leads the ConcepTION project on drug safety during pregnancy and lactation. She also serves as president of vac4eu.org and coordinates COVID-19 vaccine safety studies for the EMA.
Marjolein Willemen
Marjolein Willemen, PharmD, PhD, is Medical Policy Lead at Novartis. In this role, she is responsible for driving the strategy and development of Global Guidelines to ensure patients’ rights and ethical standards across Novartis, on topics including, but not limited to, Diversity, Equity and Inclusion in Clinical Trials, Post Trial Access, and Additional Research. Another part of her work focuses on external collaborations, which includes her role as Industry Lead for IMI ConcePTION, a public-private partnership funded by the Innovative Medicines Initiative. Before joining Novartis, Marjolein worked for Tillotts Pharma, and she started her career at the Medicines Evaluation Board (MEB) in the Netherlands, where she worked in drug safety and pharmacovigilance for more than 10 years before joining the pharmaceutical industry. Marjolein is a pharmacist and a clinical epidemiologist by training and holds a PhD in clinical epidemiology and a PharmD from Utrecht University in the Netherlands.
Pieter Annaert
Details to come
Thomas Zadrozny
Details to come
Jasper Levink
Details to come