Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Irene Cecchini works as a principal scientist in Merck Biotech's product development division based in Guidonia Site, close to Rome, Italy. She graduated in analytical chemistry at the University of Rome in 2003, and in the same year joined Serono as an analytical methods development junior researcher. In the following years she developed her expertise, particularly in extractables and leachables (E&L), elemental impurities (EI), and sub-visible particles (SbVP). In 2016 she was appointed lab manager of the E&L group, where she managed E&L studies on the final biotech products containers, as well as for manufacturing processes components (single-use systems) and coordinated analytical investigations linked to manufacturing processes issues. Since 2019, she has been a principal scientist in the impurity analytics unit of analytical development biotech department dealing with chemical and biological process impurities. In this role she contributes to building up strategies for her department's core business, especially looking for cross-functional synergies. She is a member of ELSIE and BPOG industry consortia for E&L topics. She recently joined EFPIA and PhRMA working groups as a Merck representative expert following the development of the new ICH Q3E.

Armin started his career at Ciba in 1995. He was responsible for the GLP & GMP lab for organic analysis, migration studies, E&L investigations, development of GMP QC methods, and stability testing. After 2010 Armin worked as a consultant and Qualified Person (QP) for Intertek C&P in Basel. Since 2016 Armin has a position at Sartorius as Principal Scientist.

Armin is a lecturer and trainer in E&L conferences and seminars, and he is a member of ELSIE- and the BPOG-supplier group. Armin is German delegate in the Pharmacopeia expert group 16 of the European Directorate for the Quality of Medicine (EDQM).

Dr. Reinhard Stidl is Managing Director of the independent consultancy office Safetree Consulting e.U., founded in 2018. Reinhard holds a Master in Chemistry (University of Vienna, 2002), a PhD in Chemistry (University of Vienna, 2007), a Master of Advanced Studies Toxicology (Medical University of Vienna, 2007) and is EUROTOX registered toxicologist (ERT) since 2011. Before working as a consultant, he gained more than 10 years of experience as a Toxicological Risk Assessor and team leader at Baxter, Baxalta, and Shire, where his last assignment was Associate Director Toxicological Risk Assessments.

 Dr. Stidl is an internationally known expert in chemical safety assessment in the context of pharmaceuticals since 2010, with a strong focus on extractables and leachables (E&L). During the assignments in the pharmaceutical industry, he was responsible for the global design and refinement of the global safety assessment strategy within Baxter, Baxalta, and Shire. Today, he provides his expertise to clients around the world, assisting in making pharmaceutical and medical products safe for patients.

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010, he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry.

With over 25 years’ experience in the Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Devices, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory-controlled industries are challenged by ongoing regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from the Life Industry or organizations to work together to realize or achieve a better and effective cross-departmental collaboration to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Dr. Michael Jahn is leading Forensic Chemistry at Lonza’s Drug Product Services in Basel, Switzerland. In the eleven years prior to this (Ciba Expert Services, Novartis), Michael was setting up and leading analytical laboratories that spe­cialized in trace analysis and structure elucidation with a strong focus on E&L testing. For Novartis Biologics, Michael was implementing this strategy for E&L assessment of all manufacturing, storage, and administration materials, with this contributing to numerous INDs/IMPDs and BLAs. In his current position, Michael uses his extensive analytical and regulatory knowledge on the topic of E&L to support Lonza’s customers from the (Bio) Pharmaceutical Industry.