Carsten Worsøe is a principal scientist in the analytical development department at Novo Nordisk. In his 19 years at Novo Nordisk, his main responsibility has been to develop analytical methods for Extractables and Leachables (E&L) test procedures for new drug products and devices under development. Within Novo Nordisk, Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical chemis­try together to perform risk assessments and strategies for E&L testing in de­velopment and supply projects within parenteral delivery (prefilled cartridges, prefilled syringes and pump infusion systems etc.).

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 currently heading the group toxicological risk assessments at Shire. Reinhard holds a master’s in chemistry (University of Vienna, 2002), a Ph.D. in chemistry (University of Vienna, 2007), a master’s of advanced studies in toxicology (Medical University of Vienna, 2007), and is a EUROTOX registered toxicologist (ERT). He worked as a scientist and Sr. manager at Baxter and later Baxalta, and since 2016 at Shire as the associate director. Dr. Stidl has 9 years of experience in safety assessment in the context of pharmaceuticals, and since 2010 has focused on extractables and leachables.

Ken Wong is a deputy director of process technology at Sanofi Pasteur at Swift­water PA site. His 18-year biopharma professional career has ranged from R&D to development, commercialisation and cGMP manufacturing support. For the last 16 years, he has specialised in extractables and leachables in packaging systems, including lyophilised powders, oral liquids, creams, ophthalmic solu­tions, transdermals, bio-surgical delivery systems, administration sets for inject­ables, injectable devices for combination formulations, and inhalation devices for aerosol, solutions and powders. Since 2008, he has been heavily involved with SUT and currently represents Sanofi Pasteur on the BioPhorum Operations Group (BPOG) as well as ASME-BPE, ASTM E55, the USP <661.3> Expert Panel and the ELSIE material working group.

Simone Biel is the European Field Marketing Consultant Single Use Technology at Merck. In her role she investigates the market needs in product performance, regulatory compliance, and quality of single-use systems. Simone holds a PhD from the University of Frankfurt in Microbiology.

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.

Irene graduated in analytical chemistry at the University of Rome in Italy and has been working for Merck Serono Biotech Product Development division within the protein chemistry department, since 2003. She worked in the ana­lytical method development group for ten years, where she was responsible for the development of analytical methods for the evaluation and monitoring of critical quality attributes in finished products, final drug substances and pro­cess intermediates. Now she is the extractables and leachables and process troubleshooting laboratory manager; taking care of the E&L studies on the final products container closure systems (CCS), final bulk storage containers, as well as for biotech products manufacturing process materials. Also Irene is an active member of ELSIE, and BPOG industry consortia, where she contributes to the drafting of best practice papers and other teams’ activities.

Lothar Habel is working as a study director for extractables and leachables projects at Toxikon Europe, with a strong focus on parenterals and injectable applications. After his Ph.D. graduation in organic chemistry at the University of Frankfurt am Main (Germany), he spent several years with research projects at universities and private companies in Germany and Belgium where he gained experience in preparative and analytical organic chemistry. In 2006, he joined Toxikon Europe, a CRO located in Leuven (Belgium) with a high reputation and expertise in the field of E&L.

Tom van Wijk is a senior scientist with 20 years of experience in pharmaceutical analysis. He is working at Solvay Pharmaceuticals in early and late phase chemical and pharmaceutical development and currently supporting established marketed products at Abbott Healthcare Products in the analytical science and technology department. He specializes in small molecule impurity profiling, mass spectrometry, and method development for the active materials as well as the formulated products. One of his key interests is developing applications and strategies to control trace levels of potential mutagenic impurities in pharmaceutical products. He received his Ph.D. from the faculty of pharmaceutical sciences at the Utrecht University in November 2016.

Tino Otte joined Intertek (Switzerland) AG in 2016 as a senior scientific consultant specialising in extractables/leachables analysis and GMP testing. Before working at Intertek, he studied analytical and polymer chemistry in Leipzig and Halle (Germany). After earning his PhD at Darmstadt Technical University (Germany), he worked for different companies in the instrumental analysis and pharmaceutical services industry. Within Intertek Group, Tino is responsible mainly for projects related to trace analysis, drug and impurity characterisation, and polymer testing.

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 PhD/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 of a business development manager in 2010.

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address solutions for 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 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 Device, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory controlled industries are challenged by on-going 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 Life Industry or organizations working together to realize or achieve a better and effective cross-departmental collaboration in order to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Mike Ludlow is a technical manager working in the CMC analytical team within LGC’s Laboratory Managed Services Division. The team supports an extensive external client base providing a variety of chromatographic and spectroscopic techniques covering both organic and inorganic characterisation. He has 20 years’ of experience in pharmaceutical analysis primarily in the areas of extract­ables and leachables testing and the identification of impurities. Before work­ing for LGC, he worked in the corporate analytical function of ICI’s chemicals and polymers division providing support to R&D scientists developing speciality polymer products.

Dr. François Bianchi is head of global packaging migration for B. Braun Hospital Care. In this role, he is responsible for defining the strategy and to establish the studies with staff from different departments covering the following responsi­bilities: analytical, packaging materials, toxicology, formulation, regulatory and quality. Ultimately, his responsibility is to deliver risk assessments for E&L test­ing in development and life cycle management projects.

After completing his master’s in polymer chemistry at the University of Louvain, Belgium, Bram Jongen acquired a PhD in water soluble polymers used for advanced drug adminis­tration. Bram started working as a technical support manager for Datwyler about 14 years ago, supporting customers in a vast area that spanned from Western European countries to countries like India, Korea, and South Africa. Thereafter, he headed the Global Product Introduction & Support team, a global team of highly experienced and educated people, each having their own expertise in the world of pharmaceutical closures. Bram himself ac­quired profound extractables & leachables expertise. His team managed customer projects of technical nature and supported Datwyler’s product and portfolio management. Since the end of 2012, he has been acting as head of R&D, leading a group that focuses on develop­ing new rubber and new coating materials.

Pete is a European and RSB/BTS registered toxicologist with 39 years’ of experi­ence in reviewing and critically evaluating toxicological data and other scientific information. As Bibra Director of Toxicology, he takes a lead role in extractables and leachables health risk assessment, partnering pharma, analytical compa­nies, and packagers. Other responsibilities include health risk assessments of pharmaceutical impurities and contaminants, PDE derivation, health risk as­sessment of genotoxic impurities, ICH M7-compliant assessments and biocom­patibility evaluation of medical devices.