ORADORES:

Joerg Schlingemann, Ph.D. Director, Global Quality Control Principal Expert - Germany

Joerg Schlingemann is a director and principal expert for quality control systems within Merck's healthcare quality unit. He studied molecular biology in Uppsala and Heidelberg, where he completed a doctorate degree at the German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry in various roles within quality control and quality assurance. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines, based on which he has authored or co-authored several scientific publications dealing with analytical challenges, NDMA in metformin, nitrite in excipients, and the prevalence of NDSRIs. Joerg is an advocate of scientific collaboration, data sharing, and expressive visualization of data.

Raphael Nudelman, Ph.D., ERT Senior Director Impurity Expert - Israel

Raphael has over 20 years of pharmaceutical industry experience. He has a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, a post-doctorate at the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and another post-doctorate at Duke University Medical Center, North Carolina. In 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals. In 2010 he established the Chemical & Computational Toxicology group in Teva, and now he is Senior Director Impurity Expert in R&D Operations. Raphael’s main topics of expertise are impurity and excipient qualification in drug substances and drug products. Over the past few years he has specialized in risk assessment of nitrosamine impurities in pharmaceuticals.

Andrew Teasdale, Ph.D. Senior Principal Scientist, Head of Impurity Management – UK

Andrew Teasdale, PhD, is a senior principal scientist in AstraZeneca's impurity management and external advocacy. Andrew has over 20 years of experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s impurity advisory group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son)

Naiffer Romero, M.Sc., MPH Principal Scientist, Scientific Affairs – USA

Naiffer has more than 18+ years of pharmaceutical industry experience. In his 10 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, manager in charge of compendial support, and leading trainer for supporting regulatory agencies in the LATAM region. Naiffer joined USP’s Scientific Affair function where he leads scientific outreach and engagement for LATAM & US region on Nitrosamines Impurities. His combined pharmaceutical expertise includes Analytical development, salt and polymorph selection, Development of Dissolution methods, IVIVC, and impurity analytical strategy. Naiffer also serves as a member of USP’s Nitrosamine Steering Committee, Pharmacopeial Discussion Group (PDG) nitrosamines working group, and community host to ‘Nitrosamine Exchange,’ a knowledge community on All-things Nitrosamine.

Amanda Guiraldelli, Ph.D. Manager, Scientific Affairs – Germany

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager and principal scientist in the compendial science group-general chapters. She also serves as scientific liaison for the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards related to analytical procedure lifecycle/validation. Previously, Amanda worked as a senior scientist at the USP reference standard laboratory for 8 years with the characterization of compendial standards. She is a visiting professor at the Institute of Chemistry at the University of Campinas (UNICAMP) in Brazil and is a frequent speaker and instructor on topics related to analytical procedure life cycle, Analytical Quality by Design (AQbD), and Chromatography. Amanda is a specialist in mass spectrometry, chromatography, omics, and chemometrics and has more than 15 years of experience in pharmaceutical R&D areas. Prior to joining USP, she was an R&D scientist in the Brazilian pharmaceutical industry and a visiting scientist at TU Berlin in Germany and Leiden University in the Netherlands (Center for Proteomics and Metabolomics), working on protein characterization by LC-HRMS and procedure development using UHPLC-HRMS. Amanda is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the FCFRP - University of São Paulo.

Hugo Cortes Senior Mass Spectrometry Specialist – Mexico

Hugo Cortés is a senior specialist in mass spectrometry at Waters Corporation, a position he has held for 11 years. He attended the National Polytechnic Institute College of Biomedical Sciences in Mexico where he studied biochemical engineering. He has worked in analytical development in pharmaceutical, environmental, food safety, natural products research, metabolomics, and toxicological analysis areas with Waters products for 20 years. He has participated in developing methods for analyzing nitrosamine together with regulatory entities in Mexico for four years.

Antonio Hernandez-Cardoso, M.Sc. Senior Principal Scientist – USA

Since July 2005, Antonio has worked at USP providing general scientific support within the Global Science and Standards Division (GSSD), specifically in the General Chapters Department, coordinating the volunteer experts works for the development and revision of general chapters by supporting Expert Panels and Subcommittees of the Physical Analysis-, Chemical Analysis-, Dosage Forms-, and Measurement and Data Quality- Expert Committees, assisting in the development and revision of general chapters and responding to internal and external queries related to USP–NF. Specific areas of expertise include impurities in drug substances and drug products and water for pharmaceutical and analytical purposes. He is member of the AAPS and the USP liaison to the ISPE. Antonio brought fourteen years’ experience in pharmacopeial issues working for the Mexican Pharmacopeia developing the Allopathic, Homeopathic, and Herbal Pharmacopeias, and special publications for medical devices and drugstores. Also, Antonio has taught compendial topics to the pharmaceutical industry and general pharmaceutical topics at the National Autonomous University of Mexico for over twelve years.