Our Expert Trainers

Alice D’Alton

European Regulatory Affairs Limited, Managing Director

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. Experienced in managing EU compliant dossiers (Modules 1 – 5) including compliance, DCP/MRP variation applications, Regulatory Strategy for the EU and Accession Territories, including in-licensing, Quality Overall Summaries for human and veterinary medicinal product applications and Type II variations, Paediatric Investigation Plans (PIPs) for new fixed combination applications and Paediatric Use Marketing Authorisations (PUMAs), Clinical Trial Applications, including the Voluntary Harmonisation Procedure (VHP), Orphan designation applications, Scientific advice and pre-submission meetings with the EMA and national Competent Authorities, Running and support of Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure, and national applications, eCTD software and lifecycle management, Quality Management System and SOPs incorporating regulatory affairs, pharmacovigilance, quality and admin functions, Team and Human Resource Management of varying levels of experience and job descriptions and responsibilities Qualifications include a degree in Environmental and chemical science as well as a certificate in counselling. Pre-pharma experience includes working as an Environmental Laboratory technician, Quality Control Analyst and Scientific Information Specialist (processing and reviewing published literature for inclusion in a searchable database tool). We are live on webchat!

Donal O’ Grady

Knowledge Path, Ireland, Principal Consultant

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. With a background in small and large molecule end to end value stream leadership, he brings deep operational knowledge to engagements. As a certified Lean Six Sigma Black Belt, he also utilises best practice lean methodologies in developing sustainable value optimisation programs. He now works as a consultant, advising a wide range of clients in CMO best practice. We are live on webchat!

Dr. Eduardo Jule

Technical and Business Consultant, Evolve Consulting

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 by the end of the decade marked the inception of an exhilarating journey. For six years thereafter, I dedicated myself to pioneering research in polymer-based nanoparticle drug delivery at the University of Tokyo, navigating the realms of academia and cutting-edge nanotech startup NanoCarrier (Tokyo, Japan). Joining Capsugel in 2004 (Belgium and France) was a pivotal move fuelled by a compelling vision: to promote oral lipid-based formulations as a unique solution to tackle solubility and bioavailability challenges. Over the course of 18 years within the Capsugel and Lonza families (2004-2022), I served diverse roles spanning Business Development, Pharmaceutical Sciences, Pharmaceutical Development, and Regional Sales Leadership. At that time, my expertise culminated in leading a development team that achieved remarkable milestones, from shepherding a new chemical entity through Phase 3 trials to conceptualising formulations that led to groundbreaking patents evidencing the benefits of lipid-based drug delivery. With a career trajectory spanning startups and corporate landscapes, this journey has seamlessly blended scientific acumen, technical proficiency, and strategic business insight as I moved into Sales Leadership roles (2016-2022), underscored by multilingual fluency and a global perspective honed across 30 years in five countries across three continents. It is this trajectory that led me to create Evolve Consulting in 2022, a consultancy that aims at supporting Pharmaceutical Development through Technical Advisory in drug delivery, Business Development, and Strategic Advisory Services that connect Pharma companies to the right services provider, boost CDMO efforts to create and nurture Customer bases in new markets or spaces, support innovators in building a presence and staying relevant. We are live on webchat!

Dr. Felix Tobias Kern

Associate Director – Head of Compliance Launch and Technology Center

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. In the past 6 years he worked as a QA Manager in a worldwide operating medical device and medicinal product company, as well as head of manufacturing for the production of bulk tablets. Same time he gave lectures and practiced as consultant in the fields of GMP, quality, risk management, as well as regulatory requirements in the fields of medicinal products and medical devices. On top, Felix was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes. We are live on webchat!

Dr. Gwen Wise-Blackman

BioData Solutions, USA, Senior Consultant

Dr. Wise-Blackman is a consultant and project lead at BioData Solutions. 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. She has over 24 years of experience in both mid-size pharma companies and contract research organizations. She has led detail-oriented teams to successful completion of client projects. Her focus is on pharmacokinetic (PK), pharmacodynamic (PD) biomarker, immunogenicity, neutralizing antibody, and cell-based assays. Dr. Wise-Blackman earned her Doctor of Philosophy degree in pharmacology from the University of Virginia. She received her Bachelor of Science in Biology from the Massachusetts Institute of Technology. She is a sought-after trainer for bioanalytical method development and validation, technology transfer, and implementing process controls for challenging cell-based assays. We are live on webchat!

Dr. Hans Rogl

MorphoSys, Director / Deputy Head of Production

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. In the following time, he assumed roles in technical development at Roche and later as associate director at Boehringer Ingelheim Pharma GmbH & CoKG. Currently, he works as a manager in technical regulatory affairs at Roche. During his career, he had additional responsibilities as a subject matter expert for viral safety. He has hands-on experience in conducting virus validation studies and deep knowledge of current regulatory requirements and practices regarding viral safety. We are live on webchat!

Dr. Karl-Heinz Huemer

(Formerly a Clinical Assessor at the Austrian Agency for Health and Food Safety and the European Medicines Agency)

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 (scientific office) and was a member of the Paediatric Committee (PDCO) and the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA) for 15 years. Currently Dr Huemer is now regulatory and scientific consultant. We are live on webchat!

Dr. Laura Buttafoco

Protea, CEO

Laura has extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements. This includes writing and revision of CMC regulatory documentation for the drug substance and drug product used in veterinary and human hormonal therapy, antibiotics, statins, vaccines and over-the-counter medications. Laura’s experience brings a unique combination of scientific background and effective communication skills that are well-matched with her international perspective and experience. She was responsible for the outsourcing of all analytical and processing activities related to the development, scale-up, tech transfers and validation of pharmaceutical products within multidisciplinary teams managing in DSM, Janssen and Disphar. Laura also has in-depth and direct experience in collaborating and managing CROs and CMOs in culturally diverse environments, mostly within Europe and Asia (especially India and China). She is certified as an independent ICH-GCO and GLP auditor in clinical trials. We are live on webchat!

Dr. Len Pattenden

CMC Expert and Independent Consultant 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 been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. 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. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. We are live on webchat!

Dr. Manfred Fischer

General Manager, Manfred Fischer Consulting

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. During his professional career he has worked at AstraZeneca, Altana Pharma and Eli Lilly and has held various managerial positions. In 2017 he became VP of pharmaceutical development of inhalation drug products at Vectura. Since 2021 he became owner and managing director of Manfred Fischer Consulting. We are live on webchat!

Dr Mark Powell

Mark Powell Scientific Limited, UK, Director

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. He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, and stability/stress studies. We are live on webchat!

Dr. Michael Braun

Boehringer Ingelheim Pharma, Director Late Stage Drug Product Development

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 the pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma. In 2006, Michael joined Boehringer Ingelheim and worked in different positions with increasing responsibility within Pharmaceutical Development and R&D Project Management. Since 2014, he is Director Late Stage Drug Product Development and responsible for process development and scale-up of solid and liquid orals, parenterals and inhalative NCE products. This also includes product transfers to operations, launch support and preparation of submission documentation. We are live on webchat!

Dr. Paula Muniz

Dynakin, Senior Associate

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. She is also a MSc in Clinical Research from the University of Cardiff and an MBA from the Barcelona School of Management from Pompeu Fabra University. Paula has more than 15 years of experience within the pharmaceutical industry in an international setting where she has worked on regulatory strategy, clinical study design and result evaluation in several indications for a NCE and a fixed dose combination for EMA and FDA submissions. Focusing on comparative bioavailability, in vivo in vitro relationships/correlations, and pragmatic application of regulatory requirements, she has participated in the development of numerous complex immediate and modified release pharmaceutical alternatives for oral, inhalation, and intramuscular routes. She has also set up and participated in scientific meetings with EMA, national authorities, and the FDA. Since her initial involvement with Dynakin she has built experience in the regulatory application of modeling & simulation and population PK/PD methods for the evaluation of interactions, pediatric product development, and bridging between populations. We are live on webchat!

Dr. Peter Riechel

T3 Consulting, Germany, Director

Peter is a seasoned quality management expert with over 25 years of experience in the pharmaceutical and biopharmaceutical industries. He has held pivotal roles in international operating companies, which have given him a deep understanding of regulatory compliance and quality assurance challenges. As a Director of T3 Consulting in Germany, he has been at the forefront of advising companies on the complexities of contract manufacturing. His extensive background includes expertise in Analytical Development, Quality Management Systems, and Annex 1 compliance. Peter has developed strong connections within the CMO world, having guided numerous organizations through the selection, qualification, and management of contract manufacturers. His practical, hands-on approach has enabled him to successfully implement risk-based strategies and robust quality agreements. He has been working as an independent consultant since 2013, delivering targeted solutions tailored to meet industry-specific challenges. His training sessions are enriched by real-world examples and case studies drawn from his vast experience. Peter’s in-depth industry insight is complemented by his ability to simplify complex regulatory and operational issues into actionable strategies. His expertise in technology transfer and CMO oversight further reinforces his role as a trusted advisor in the contract manufacturing space. Ultimately, his proven track record and extensive network make him the ideal trainer to navigate today’s evolving contract manufacturing landscape. We are live on webchat!

Dr. Sam Denby

Managing Director, Biofrey

Managing Partner, BioFrey, United Kingdom Dr. Denby is a Biochemical Engineer with over 20 years of experience in the bioprocess industry. He received his Engineering Doctorate in Biochemical Engineering and Bioprocess Leadership from University College London. Sam began his career in the process development group of Cambridge Antibody technology and was engaged in multiple technology development and transfer projects throughout the acquisition by AstraZeneca and merger with Medimmune. Sam subsequently joined Oxford BioMedica and was instrumental in establishing many of the process development Philosophies still in use today. Between 2010 and 2016, Sam was a technical consultant for Becton Dickinson’s Cell culture media products with responsibility for Europe, the Middle East and Africa and was involved in a number of key projects for clients with biologic products generating annual revenues of up to $16bn. Sam founded BioFrey in 2017 and has revolutionised the availability of extractables data and change notification practices around single-use systems facilitating the uptake of these systems that have proven crucial in the ongoing pandemic. Sam is currently providing CMC consultancy for a late-stage monoclonal antibody. We are live on webchat!

Dr. Simon Day

Clinical Trials Consulting & Training,

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. He now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice/end of Phase II meetings and preparations for oral explanations and advisory committees. He is particularly well known for his work in the area of developing treatments for rare diseases. Simon has served on a variety of data monitoring committees both for industry-sponsored and government-sponsored trials. He is chairman of the External Advisory Panel for the Department of Statistics at Oxford University and an Associate on the faculty at Johns Hopkins University in Baltimore. He formerly served as vice-Chairman of the West London Research Ethics Committee. He has given numerous lectures and courses on statistics and clinical trials all around the world, including courses at the FDA on the development and regulatory assessment of orphan drugs. We are live on webchat!

Francois (Swa) Vandeweyer

Company Owner, VDWcGMP Consultancy gvc, Belgium

Francois (Swa) Vandeweyer is the Company Owner of VDWcGMP Consultancy gvc based in Belgium. 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. Swa retired from J&J in May 2019 and formed his own consultancy. He is a member of APIC, was the Vice Chair of the APIC Quality Working Group involved in multiple GMP Compliance documents like ICH Q7 How to do, cleaning validation, supply chain integrity and many more. We are live on webchat!

Fritz Röder, Merck KGaA, Germany

Director Engineering

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. Fritz’s areas of experience includes GMP / QA consulting in various technical questions, technical compliance and inspection preparation (FDA, ANVISA, German RP, Russia etc.). He is a responsible operator of GMP equipment, has expertise in Containment & mRNA and is a profound water treatment expert. On top, Fritz was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes. We are live on webchat!

Hanna Hanć

HMH Management Consulting, CEO

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. Although born in Poland her international experience includes having worked in Spain, Argentina, Luxembourg, Scandinavian countries and Russia. Hanna worked in pharmaceutical production including R&D and API, creative sector – including activities performed “pro public bono”, as well as education and trainings development. Working as a professional in project portfolio management – her major achievement in the field was an introduction of portfolio management processes, organization and IT supporting tools set up in the Polpharma group, the largest pharmaceutical company in Poland (product portfolio adjustment to European Union standards and regulations, including R&D processes). We are live on webchat!

Henny Zijlstra

Adragos Pharma, CCO

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. Through collaboration with cross-functional partners, she implements innovative solutions that drive customer engagement and satisfaction. Henny’s expertise extends to the complex market dynamics and regulatory landscape that governs the CDMO industry, allowing her to stay ahead of evolving customer needs. Henny is currently working as a CCO at Adragos Pharma and with a deep understanding of the industry, she delivers impactful training programs that empower marketing professionals to thrive in this dynamic and challenging environment. We are live on webchat!

James L. Drinkwater

Franz Ziel GmbH, Head of GMP Compliance

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. James is also the leader of the PHSS Aseptic processing and Biocontamination special interest group that develops GMP guidance documents that are subjected to regulatory review before publication. James is also a member of ISPE and PQG (Pharmaceutical Quality Group UK). Current projects relative to this training span biological product filling lines, ATMP (Advanced Therapeutic Medicinal Products) combined formulation and filling platforms and associated sterility testing. We are live on webchat!

James Pink

Health Sciences and Medical Devices Consultant

James Pink has over 25 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. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards. We are live on webchat!

Rob Walker

Rob Walker GMP Consultancy Limited, Director

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry. He has over 30-year experience in the Pharmaceutical industry including 25 years as a Qualified Person. After 16 years in senior management at CP Pharmaceuticals, the last 7 as Quality Director, he is now a director of his own GMP consultancy company operating across the Global Market. Rob has extensive GMP Manufacturing and Quality experience covering a wide range of dosage forms, in particular aseptic sterile products, and has successfully managed GMP inspections by MHRA and FDA for primary and secondary manufacturing in the UK and overseas. He has performed GMP audits and training encompassing all elements of the global pharmaceutical supply chain. A member of a number of pharmaceutical industry professional organizations, Rob has delivered numerous presentations to Industry/Regulatory forums in both the EU and the USA on current GMP issues. He has edited technical reports for professional bodies on steam sterilization, and contributed to pharmaceutical industry monographs on media fills and integrity testing of sterile products. He has also represented the UK Pharmaceutical Industry in regulatory meetings in the EU and USA. We are live on webchat!

Ruth Faulkner

Founder & Content Strategist, Toucan Content

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. Ruth brings a background as a journalist, working at four Olympic & Paralympic Games and writing for major publications. More recently she’s refocused those skills into business content marketing and strategy, leading content programs for GSK and Adragos, as well as advising on content marketing for global businesses in other industries, from FIFA to AXA. We are live on webchat!

Simone Ahrens-Mende

Biometrics Specialist, Ahrens-Mende Associates

Simone Ahrens-Mende holds a Diploma in Mathematics and a Master’s degree in Clinical Trial Management. She is a highly experienced leader in clinical research, with over 25 years of expertise in Data Management, Statistical Programming, and Biostatistics. Throughout her career, she has held senior positions in international CROs, where she has successfully led cross-functional teams, optimized clinical processes, and ensured compliance with global regulatory standards. Simone is known for her strategic leadership, process innovation, and dedication to quality, having contributed to the success of numerous clinical trials across various therapeutic areas. She brings a unique combination of technical expertise and a strong commitment to mentoring and developing professionals in biometrics and clinical research. We are live on webchat!

Steven Walfish

Statistical Outsourcing Services, USA, Independent Consultant

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. Mr. Walfish holds a Bachelor of Arts in Statistics from the University of Buffalo, Master of Science in Statistics from Rutgers University and an Executive MBA from Boston University. We are live on webchat!

Tara Scherder

SynoloStats, USA, Principal

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. She combines statistical expertise with extensive knowledge of manufacturing platforms/analytical sciences and CMC requirements, always within business and regulatory context to achieve goals. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. We are live on webchat!