PANEL DISCUSSION
Monday, September 23
06:00 PM - 07:00 PM
Live in Berlin
Less Details
Discussions around digital product information for medicines are making waves across pharma and healthcare. Stakeholders from contrasting perspectives are now looking at how they can answer some of the industry’s biggest questions around patient outcomes by understanding what is possible by using improved standards for medicines information. Regarding ePIL the leaflet is an integral part of any medicine. Moreover, according to the EU Legislation, it is obligatory to include a package leaflet with all medicinal products, unless all the information required is directly conveyed on the packaging. However, the pharma supply chain and its essential units are undergoing transformation due to digital transformation, and the leaflets are no exception. From paper to digital leaflets, the industry found a solution that makes patient information more inclusive, reducing the negative impact on the environment in many different ways. More and more countries together with the respective regulatory organizations are starting to introduce various initiatives and projects regarding electronic leaflets implementation. The core questions to be discussed are:
Being a mathematician and chemical engineer by profession Stefan is involved in pharmaceutical serialization since its early days in 2008 and renowned as one of the fathers of the European ‘Point-of-Dispense Verification’ model that ensures patients’ access to safe medicines.
For more than seven years Stefan worked as a delegate consultant for the European Federation of Pharmaceutical Industries and Associations (EFPIA) where he contributed to the successful verification pilot in Sweden in 2009 / 2010 and played a key role in the design and development of the European Medicines Verification System (EMVS) that constitutes a key component in the implementation of the EU Falsified Medicines Directive (FMD).
Once having returned from Brussels Stefan led Bayer’s activities to implement the Brazilian Track&Trace requirements in 2014 and 2015 before his focus shifted back to the roots as the responsible program manager for the timely FMD readiness of Bayer’s Pharmaceuticals and Consumer Health divisions by February 2019. Currently, he manages Bayer’s rollout of Track&Trace for Brazil that was restarted by ANVISA in 2020.
Beyond his project assignments Stefan Artlich engages on a strategic level for supply chain improvements ensuring patients’ safety and uninterrupted access to medicines. As an example, he serves since 2016 as an elected member of the GS1 Healthcare Leadership Team that steers GS1 Healthcare’s activities for the integration of GS1 standards into the supply chain processes of the healthcare sector in order to drive patient safety and supply chain efficiency improvements not only in the private but as well in the public sector.
Carolin Dose holds a Bachelor’s degree in Business Administration, specializing in Supply Chain Management and Finance, followed by an MBA in Digital Health. Currently, she is working in Global Supply Management at Bayer in Berlin, where she is coordinating the implementation of global Track & Trace requirements at Bayer’s supply centers and contract manufacturing organizations. She dedicated her Master’s thesis to the challenges associated with the implementation of electronic product information (ePI) at pharmaceutical manufacturers. For this topic, she also serves as a contact person between Supply Chain Management and Regulatory Affairs.
Alexander works as project manager for track & trace in the global serialization team of Fresenius Kabi based in Germany. He is responsible for supporting the sites mainly in Europe in the implementation of the line and site systems (L2 and L3) as well as the connection to the central L4 systems. Therefore, his knowledge expands from packaging operations over serialization to IT systems.
The tasks he is responsible for, start from gathering requirements for the individual plants or lines together with the local teams, continue with the evaluation of the proposals from internal and external suppliers and end with successful implementation and validation on site.
Prior to joining the Fresenius Kabi serialization team Alexander worked as a project manager for a serialization solution provider as well as project manager in other industries.
The pop in your job: "Always deliver the best solution despite having continuously and rapidly changing requirements as well as significant contraints."
Experienced Project Portfolio Manager with demonstrated history of working in the pharmaceuticals industry focusing on leading global teams in international projects for Product Digitalization, Serialization, Track and Trace.
The Pop in Your Job:
Connecting the dots in complex international projects and working with people around the globe to achieve a common goal.
I have more than 30 yrs experience in Pharma & Biotech. I worked in Logistics as VP Business Development and Quality at a Global logistics company responsible for development of business strategies and for management of GDP quality globally. I designed logistics, warehousing and courier strategies for most of the top 20 Pharm companies and assessed almost all major airports/airlines in the world. I have deep experience and knowledge in FDA Inspection readiness/recovery from regulatory cmc to product launch including QC, QA, Process criticality, QMS, IT system design and validationOperational excellence & organisational fitness.
The Pop in your Job: I love my job and am very passionate about it because I get to take care of patients and I love to succeed despite any odds. I focus on the critical, coach my teams to be better than me. I like to KISS (Keep things simple Stupid) and implement pragmatic systems that deliver Right 1st time all the time every time.