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Mark Birse
Vice President, Technical at Parexel17 years at MHRA: Deputy Director Inspection, Enforcement & Standards Division & Head of MHRA Inspectorate and Process Licensing (over 75 GXP inspectors in team). Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Senior GMP & GDP Inspector prior to holding leadership roles. Eligible Qualified Person since 2003
Sinéad Cowman
Global Business Development & Marketing Manager – Informatics at LonzaSinéad studied Microbiology at Trinity College Dublin and has over 20 years’ experience in the Pharma Industry. She joined Lonza in 2005 to manage their endotoxin business in Ireland and for the past 10 years has been involved in their informatics division. She has worked with many organizations from small biotech to global pharmaceutical companies to implement paperless solution for Quality and Manufacturing helping them achieve an automated integrated approach to data collection and evaluation. She recently completed a PGDip in Strategy and Innovation at Oxford University and is focused on driving the strategic direction of informatics at Lonza.
Thomas Halfmann
Director, Global Head Production & Laboratory of NNITThomas Halfmann is an advocate of digitalization in Life Sciences Production and Supply Chain with more than 25 years of experience in manufacturing IT and automation in the life sciences industry. After various management positions at Novartis, including Head Global Project Office, Global MES Program Manager and Global Head Biopharmaceutical Operations IT, Thomas co-founded the international life sciences consulting group HGP in 2008. HGP had offices in Switzerland, Germany, Singapore, Poland and Indonesia and was acquired by NNIT in 2019. Since October 2019 Thomas is the Global Head Production & Laboratory for NNIT. He is a frequent speaker at international life sciences conferences, author of various publications and member of industry associations like ISPE.
Bruce Loxley (Moderator)
Senior GMP Compliance Advisor at GlaxoSmithKline VaccinesBruce Loxely performs regional and global auditing of GSK Vaccines and third party provider sites and functions focusing on Asia Pacific. He has 29 years in the Pharma and Vaccines businesses, variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.
Bruce has been a PDA Singapore Chapter member since 2014. Since February 2020 he has been PDA Singapore Chapter President
Siegfried Schmitt (Moderator)
Vice President, Regulatory & Access at ParexelThought Leader in Competitive Compliance, Data Integrity and Supply Chain. Trusted expert for regulatory, compliance and industry-best-practices projects. 30 years experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. Provider of practical solutions to overcome business interruptions
Niels Visschers
Specialist Microbiology at MerckNiels joined Merck in 2002 starting his career as a microbiological analyst in the QC- Micro lab. During the first years he worked with all compendial methods like EM, Bioburden and Sterility. Subsequently Niels was project lead of an Isolator implementation and became assistant lab coach in 2016. In 2020 Niels transferred to the Global Center of Expertise Microbiology / AVA within Merck. He is mainly responsible for design and execution of development studies in Rapid Microbiological Methods for EM. Niels holds a bachelor’s degree in Clinical Chemistry & Hematology.