Speakers

Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma.

Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements.

Started in Pharma Regulatory Affairs over 14 years ago, initially in a manufacturing facility in Ireland. Joined Ivowen regulatory affairs consultancy over nine years ago and became Regulatory Affairs and Business Manager after four years. Became Managing Director and owner of the consultancy in 2021.

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies.

Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017, he founded BioFrey and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups

Meet Ruth, an experienced content expert with a proven track record of using storytelling within the Pharma and CDMO industry as a tactic to drive trust, engagement, and lead generation.

Dr. Manfred Fischer is a Biophysical Chemist. He has more than 30-year experience in the pharmaceutical industry, mainly in the CMC arena covering analytical / formulation development of new and generic products and Quality Control of medicinal products.

Donal is a (bio) pharmaceutical leader, with over 25 years’ experience in the industry. Over the last 12 years, he has held roles in global external network strategy, procurement and operations in a number of companies, including BMS, Zoetis and Biomarin.

Qualified and experienced in business management, consulting and project management (MBA,PMP). Hanna is a business management consultant, having a considerable experience in companies undergoing restructuring, particularly as a result of privatization.

Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.

With over two decades of immersion in the dynamic realm of drug delivery, I have cultivated a profound passion for this field since my first encounter in the mid-1990s. Transitioning from pioneering the assessment of naturally derived surfactant emulsification properties in personal care to delving into the intricacies of pharmaceuticals in by the end of the decade.

Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.

Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is a Doctor in Pharmacy at the University of Navarra with a PhD in cardiovascular pharmacology.

Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.

James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.

Peter is a quality management expert with 25+ years in pharma and biopharma, specializing in CMO oversight, quality assurance, and regulatory compliance. As the Director of T3 Consulting, he has advised companies on selecting, qualifying, and managing contract manufacturers. His expertise spans analytical development, Quality Management Systems, Annex 1 compliance, and technology transfer.

Dr. Hans Rogl is a Biochemist by training and started his industry career as a manager of a downstream process GMP production facility at Roche Diagnostics GmbH in Penzberg, Germany.

Fritz Röder is Director Engineering at Merck KGaA in Germany and is a recognized expert in the pharmaceutical industry. He has large experience in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms.

Tara Scherder has over 20 years’ experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk.

Swa joined Janssen Pharmaceutical (part of Johnson & Johnson) in 1981 and until 1995 had increasing responsibilities within the organisation, mainly in the Quality Control Unit. From 1995 he joined the Quality Assurance department. In 2005 was Senior Manager GMP Compliance Chemical Operations in Belgium, on sites Geel – Olen – Beerse. In 2009 was appointed as Director Global Compliance of EMEA and Asia Pacific for Johnson & Johnson.

Steven Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry.

Dr. Wise-Blackman is a consultant and project lead at BioData Solutions, with over 24 years of experience. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.

Meet Henny, an experienced commercial leader with a strategic and innovative mindset. With a proven track record of driving business growth and success in the competitive CDMO marketplace, Henny is dedicated to building and managing high-performance teams in marketing and sales.