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
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.
Dr. Tony Cundell worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.
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.
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.
Jan Harmsen has more than 40 years of industrial experience in research, development, design, and commercial scale implementation of processes in oil & gas, chemicals, food & beverage and minerals.
Dr. Huemer works at the Austrian Medicines & Medical Devices Agency, participating in many assessments of scientific advice procedures, paediatric investigation plans and centralized marketing procedures in different clinical areas. He is a SAWP full member since 2014 and a PDCO full member since 2013.
Johan is a senior Life Science consultant with more than 25 years of experience within the Biotech and Biopharmaceutical industry. He has a successful track record in a variety of roles: Director, Senior Project Manager, Quality Subject Matter Expert.
Dr. Felix Tobias Kern is Head of Manufacturing 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.
Helge Neidhardt has over 30 years of pharmaceutical development experience with biologics covering projects on high purity natural proteins, recombinant proteins, monoclonal and conjugated antibodies. He worked at Aventis Behring and at Sanofi in different responsibilities, leading internal as well as collaborative CMC projects through all stages of development with EMA and FDA.
Franz Nothelfer is currently a professional consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as associate director Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG.
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.
Dr. Rensing studied biology and medicine biology and medicine at Tübingen, Heidelberg and Amherst, USA. During his clinical career he contributed to more than 40 clinical trials in all phases. He has worked in hospital management and more importantly in the pharmaceutical industry as well as at The Paul-Ehrlich-Institute (PEI) as a clinical assessor.
Fritz Röder is Global Engineering Manager 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.
Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities.
Majella Ryan is an analytical chemist by training and has over 30-year experience in pharmaceutical regulatory affairs. Majella set up and ran a regulatory affairs consultancy that concentrated on regulatory affairs strategy and submission for the EU.
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.
David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.