Trainers

Step into the world of pharmaceutical innovation with our team of 30+ expert trainers, each possessing a decades of hands-on experience – from initial research and testing to regulatory compliance and market release. Gain practical insights and real-world perspectives as you delve into the exciting world of pharmaceutical development with our experienced trainers.

Dr. Michael Braun

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.

DR. Karl-Heinz Huemer

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 and medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.

Donal O’ Grady

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.

David Schwicker

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.

James Pink

James Pink has over 20 years of experience in medical devices including 10 years as a lead auditor for European Notified Body. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.

Dr Mark Powell

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 Mark Waring

Dr. Waring is a licensed physician, epidemiologist and senior pharmacovigilance expert with 25 years of full-time industry and consulting experience in clinical drug safety and post-marketing pharmacovigilance. His key areas of expertise include pharmacovigilance system and process consulting, safety data assessments and safety risk management planning.

Henny Zijlstra

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.

Dr. Simon Day

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. Sam Denby

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.

Dr. Felix Kern

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.

James L. Drinkwater

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. Gwen Wise-Blackman

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.

Dr. Laura Buttafoco

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. Len Pattenden

Len has over 30 years of experience in both industry and academia. 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.

Dr. Malcolm Ross

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.

Dr. Manfred Fischer

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.

Dr. Paula Muniz

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.

Dr. Stephanie Pasas-Farmer

Stephanie Pasas-Farmer is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology.

Francois (Swa) Vandeweyer

Swa joined Janssen Pharmaceutical in 1981 and had increasing responsibilities within the organisation, mainly in the Quality Control Unit. From 2005 he was Senior Manager GMP Compliance Chemical Operations in Belgium and from 2009 he was appointed as Director Global Compliance of EMEA and Asia Pacific.

Hanna Hanc

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.

Fritz Röder

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.

Jan Harmsen

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.

Alice Dalton

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.

 Rob Walker

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

 Steven Walfish

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.

Tara Scherder

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.