Roman Mathaes is a group leader within the Lonza Drug Product Service organisa­tion. He is leading the Lonza particle lab and the container closure integrity testing. In this role, Roman is responsible for particle analytics in drug products and container closure integrity testing of vials and pre-filled syringes and process development of capping/crimping. Prior to this assignment, Roman was working within Roche/Ge­nentech network supporting process development of the commercial manufacturing. Roman is an active member of the European CCI industry focus group and part of the BPOG CCI workstream. Roman is a pharmacist by training and conducted his studies at the University of Marburg and King’s College London. He holds a PhD in pharmaceutical technology from the University of Munich for his work on subvisible particle characterisation.

Dr. Stefan Scheler is a senior scientist at Sandoz GmbH. He received his doctoral degree in pharmaceutical technology from the Friedrich-Al­exander University Erlangen-Nürnberg and performed post-doctoral re­search at the Friedrich-Schiller University Jena, where he completed his habilitation and was granted the authorisation to teach (venia legendi). He has about twelve years of experience in pharmaceutical development and worked for different companies. Beside this, he has five years’ expe­rience in hospital pharmacy. Scheler was involved in the development of a variety of different dosage forms for both small molecules and biophar­maceuticals. For a long time he has been an expert in primary packaging materials. He has published numerous papers and is a co-author of a standard textbook for pharmaceutical technology for which he has writ­ten, among others, a comprehensive chapter on packaging materials for pharmaceuticals.

Markus Hemminger is a senior engineer who joined Roche in 2013, where he is assigned to the pre-filled syringe development, a subgroup of device development, for biopharmaceuticals. Currently, he is in charge of developing a syringe for ocular injections. Before starting at Roche, he was responsible for primary packaging development for biopharmaceuti­cals at Boehringer Ingelheim for more than 13 years. His main expertise includes selection, development and optimisation of container closure systems like vials, cartridges and syringes, as well as transfer and ad­ministration devices, packaging component related method and process developments and CCI testing. Markus Hemminger studied chemistry at the University of Applied Sciences in Aalen, Germany.

Francesco Brazzarola holds a M.S. in Optics Telecommunication Engineer­ing from the University of Padova, Italy. In 2005 he worked as an R&D manager at CNR-INFM in Padova, designing and developing an oxygen detector based on the TDLAS technology. In 2006, he joined Brevetti- CEA in Sovizzo, Italy, as a researcher in the R&D department. Francesco has more than eleven years of experience in design, development and optimizing of non-imaging controls for fully automatic inspection ma­chines for pharmaceutical products. He has expertise on supporting pharma companies to apply new technologies on freeze-dried, liquid or other pharmaceutical products. Currently Francesco is filling the posi­tion of Inspection Machines Technologist at Antares Vision in Travagliato, Italy, with focus on analysis, evaluation, and implementation of inspec­tion technologies in the field of inspection machines for pharmaceutical products.

For 20 years, Dieter Mößner has been working at Edelmann as a technical project manager. He leads projects in Braille application, serialisation, tamper verification and anti-counterfeiting of pharma and consumer good packaging. He also consults customers and artwork agencies in artwork creation, print data communication and typesetting workflows. He is a convenor of CEN/TC 261/SC 5/WG 12 ‘Marking.’ This working group at the European committee for standardisation CEN has created the European standard EN 15823:2010 ‘Braille on packaging for medicinal products’ and EN 16679:2015 – the European standard on ‘Tamper verification features for medicinal product packaging.’ Dieter Mößner is a chairman of the German working groups NA 115-03-01 AA ‘Braille on packaging’ and ‘Tamper verification features for medicinal product packaging.’ After six years being the vice-chairman of the packaging standards committee NAVp at the German Standards Institute, DIN, he became its chairman in March 2013.

Bart Steenackers, born in Turnhout (Belgium) in 1987, is currently work­ing as a study director at Toxikon Europe NV. He obtained his master’s degree in bioscience engineering at the University of Leuven (2010, KU Leuven) and later his Ph.D. at the Centre for Surface Chemistry and Ca­talysis (2015, KU Leuven). As a doctoral and postdoctoral researcher, he studied the oxidation and isomerization of typical components of hops, ac­quiring expertise in organic and analytical chemistry, solvent effects, and catalysis. Mr. Steenackers joined Toxikon Europe NV in 2015 as a study director in the extractables and leachables department where his specialty fields include rubber closures and small volume parenteral applications.

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.

Andrea Simonetti received a MS degree and a PhD degree in electronic engi­neering from the University of Ferrara, Italy. In his career he has successfully led large scale commissioning, validation and quality projects for worldwide major pharmaceutical regulated companies. Standards, risk management, EU and FDA regulatory compliance are significant interests and responsibili­ties. He has designed and implemented pharmaceutical business plans and strategic development activities by leading and overseeing the activities of international sales teams. He has been also responsible for the strategic direc­tion of business units at global pharma machine manufacturers. Andrea is a frequent speaker at conferences and seminars including ISPE, PDA, BFS IOA. In 2010 he started providing stable educational support to US Food and Drug Administration Office of Pharmaceutical Science. He is a frequent contributor to leading pharmaceutical and engineering associations and his insights have been drawn on for topics ranging from conferences to scientific publications and regulatory dossiers. Most recent publications involve developing Process Analytical Technology strategies for pharmaceutical sytems and innovative Container Closure Integrity Testing methods for parenteral drugs. Andrea is currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity” and with PDA Prefilled Syringes task force teams.

Lisa Krapf has been working as an application scientist at rap.ID since 2015. She received her degree in biophysics in 2008. As a researcher at university, she gained experience in the fields of microscopy and spec­troscopy for biological applications. At rap.ID, she provides customer support for rap.ID instruments for foreign particulate matter testing as well as characterizing silicone oil layer thickness.

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.