Speakers of the ICH Q7 Week 2024

Dr Andy Bailey
ViruSure GmbH, Austria

Dr Bailey has been actively involved in the pathogen safety of biopharmaceuticals for over 11 years. Originally a Biochemist, Dr Bailey served for nine years at the MRC Virology Unit in Glasgow, Scotland. In 1995, he moved as Director of Virus Validation services to Q-One Biotech Ltd. and in 2001 to the Pathogen Safety group of Baxter Healthcare in Vienna, Austria. He was the main founder of ViruSure GmbH, a specialist virus safety testing company in Vienna, Austria, in 2005. Over the last 10 years, Dr Bailey has presented at numerous regulatory agencies on virus and prion safety, either in support of products or as an invited speaker at expert workshops.

Dr Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting, Germany

Thomas has more than 25 years of experience in the pharmaceutical industry mainly collected in senior positions with Quality Assurance, Compliance and Quality Control. 15 Thomas´ focus is on aseptic manufacturing of mainly biological drug products and on production of biological active substances, including vaccines and mRNA. Since June 2024 Thomas is working as a freelance GMP consultant. Thomas is registered as Qualified Person according § 15.3 and 3a AMG for vaccines and ATMPs.

Dr Markus Dathe
F. Hoffmann-La Roche AG, Switzerland

Analytical and Process Chemist with more than 20 years of practical experience in laboratory, quality and informatics functions. Dr Dathe held several positions in life sciences and pharma operations of Novartis since 1997, joined Siegfried in 2006 and is GMP Coordinator in the Small Molecules Technical Development of Roche since 2011. He had been successfully leading global projects in the area of CDS, LIMS and QMS.

Paul Lopolito
STERIS Corporation, USA

Mr Lopolito is a Technical Services Manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process research cleaners, stainless steel maintenance, and contamination control, which includes field support, site audits, training presentations and educational seminars. He has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. He is a frequent speaker at industry events including INTERPHEX, PDA, ISPE, ACHEMA, AALAS, and IVT. He has published several articles and book-chapters related to cleaning validation and contamination control.

Mauro Menichelli
Janssen-Cilag SPA, Italy

Mr Menichelli joined the Janssen organization in 1990. He has experience in quality and compliance in the Pharma SM finished product filling industry. He has a diploma in industrial chemistry and a law degree. Mr Menichelli has long experience in auditing of pharmaceutical / chemical companies together with the setting of the general management of supplier quality processes. He is currently part of the APIC Task Forces “Supplier Qualification & Monitoring” and “Third Party Audit Management”.

Peter Mungenast
Formerly Merck KGaA, Germany

Mr Mungenast studied Biology and Chemistry at the University in Karlsruhe. Then he worked in different functions for Merck KGaA. From 1996 to 2023, he had been responsible for cleaning validation, training and different projects in the Quality Assurance department.

Tim Ohlrich
gempex, Germany

Tim Ohlrich is an engineer in biotechnology and has been working in the GMP-regulated environment for more than 15 years. Since his start in consulting Tim has executed and led several GMP-compliance projects, from ATMP start-ups to global market leaders.

Dr Frank Sielaff
GMP Inspector, Regional Authority, Darmstadt, Germany

GMP-Inspector at the Regierungspräsidium Darmstadt with the focus on inspection of drug manufacturers and laboratories in Germany and countries outside of the EU. Before joining the GMP-inspectorate Dr Sielaff was several years employed in the pharmaceutical industry as Head of Quality Control and as Qualified Person.

Francois Vandeweyer
VDWcGMP Consultancy, Belgium

Mr Vandeweyer joined Janssen Pharmaceutica (part of Johnson & Johnson) in 1981 in chemical development. Until 1995 increasing responsibilities within the organisation mainly in the Quality Control Unit. Starting from 1995 he joined the QA department. Several Senior Manager responsibilities. 2005 Sr Manager GMP Compliance Chemical Operations Belgium (sites Geel – Olen – Beerse). 2009 Director Global Compliance EMEA/AP for Johnson & Johnson. Since May 2019 he is a freelance consultant.

Dr Karina Versyck
Johnson & Johnson Innovative Medicine, Belgium

Dr Versyck holds a PhD in Applied Biological Sciences from the Catholic University Leuven, Belgium. She has more than 20 years of experience in manufacturing of small molecule drug substances & products at Johnson & Johnson. After roles as Project Manager in equipment engineering and as Process Engineer in operations, she took up increasing responsibilities as people manager in Manufacturing Science and Technology, as Cleaning Validation Lead, at local and at global level, and currently, as Process & Cleaning Validation Lead.