Yasmin de Faria Krim is an active volunteer at DIA, as chairperson of the CMC working group within the DIA Regulatory Affairs Community. She was the program chair for the last 4 DIA CMC workshops (Washington DC), co-sponsored by AAPS and has also chaired DIA webinars focusing on CMC topics. Yasmin currently works in the consultancy area in Switzerland, and has previously worked in Belgium and the UK, in CMC Regulatory Affairs and European Regulatory Affairs. Yasmin de Faria Krim holds a PharmD and a Master in Regulatory Affairs (International Drug Development and Registration).

Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma (Novartis, Boehringer Ingelheim) and small Biotech companies. She is a long time active member of several non-for profit organizations (namely DIA) and speaks four languages fluently. Ursula holds a PhD in cell and molecular biology and an MBA she earned with honors.

Sabine Kopp is Group Lead of WHO’s Medicines Quality Assurance team. She was Secretary for the International Nonproprietary Names (INN) Programme, Programme Manager for the Quality Assurance and the Anticounterfeiting Programmes, Acting Secretary of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and actively involved in the WHO Member State mechanism on substandard and falsified medical products. Sabine Kopp is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, coordinating WHO's activities related to international quality assurance guidelines, GXPs, specifications and regulatory guidance for medicines, from their development to the supply to patients.

Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/Medimmune. He is a member of ICH Expert Working Group as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Dr. Elaine Morefield is the Vice President, Regulatory Affairs for Vaxform,LLC. where she provides regulatory and development consulting services to clients. She also is working for Aclaris Therapeutics Inc., as the director of Product Quality, She obtained her BS pharmacy and her PhD in industrial and physical pharmacy from Purdue University. Dr. Morefield worked in the Office of New Drug Quality Assessment at the US FDA where she was the deputy office director for review and administration. Dr. Morefield has over 30 years of product development experience with pharmaceutical companies Wyeth, Schering-Plough and DSM and has developed over 100 pharmaceutical products.

Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical assessor prior to joining the European Medicines Agency, where he now has the role of Head of Quality.

Dr Robert studied chemistry and obtained his PhD from the University of Basel in 1976. He had a post-doctoral training at ETH Zurich. He spent one year with a pharmaceutical company before joining the National Health Laboratory (LNS) in Luxembourg, where he was head of the Unit Pharmaceutical Chemistry, an Official Medicines Control Laboratory (OMCL). He retired in March 2015. He was a member of the CHMP at EMA since 1995 (co-opted member: 2004-2017) and chairman of the CHMP/CVMP Quality Working Party (1995-2017). He is currently EC topic leader for ICH Q12 (Lifecycle Management). He was chair of the European Pharmacopoeia Commission (2013-2016) and a member of the group of experts 10 B. Currently he is chair of the CEP Steering Committee.

Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals Working Party (BWP) at EMA and regulatory chair the ICH Quality Discussion Group. He has helped draft several guidelines such as the EMA toolbox guidance for PRIME products, the EMA reflection paper on statistical methodology, and the EMA-FDA Q&A on regulatory flexibilities. As a member of the ICMRA collaborative assessment group, Sean helped establish the first pilot programme for multi-agency assessment of post-approval CMC changes.

Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA global annual conferences from 2019 to 2023. At his current capacity as a VP, Quality and Regulatory Compliance, Global Regulatory Affairs, Novo Nordisk, Inc., he provides strategic leadership on Regulatory and Quality related Policy, External Affairs, strategic advice and solutions to quality and regulatory related challenges. Prior to industry, Andrew served more than 11 years in US FDA most recently as an Associate Director for Policy and Regulation, DH/CBER

Martin Schiestl received his doctoral degree in chemistry with a specialization in bioanalysis from the University of Innsbruck in Austria in 1996. In the same year, he started his work on Biosimilar medicines at Sandoz where he built up the analytical and pharmaceutical development departments in charge of the biosimilar portfolio and other biological medicines of Sandoz. He moved into the regulatory and policy field in 2009, further fostering regulatory sciences for biosimilar medicines and supporting development and licensing of Sandoz’ biosimilar portfolio. In his current role, he is responsible for the Global Regulatory Affairs Policy at Sandoz Biopharmaceuticals.

Oliver Schlaefli is a senior quality leader with 20 years plus industry experience in technical research and development and commercial manufacturing. He worked on important launch projects for innovative medicines, small molecules, NBE’s and biosimilar both from the development and the commercial point of view. Before joining industry Oliver was working as a GMP inspector and scientific assessor in Swiss governmental organizations such as the Swiss Federal Office of Public Health. He also engaged in academia e.g. the University of Tromso, Norway. Oliver holds a PhD in Biochemistry from the University of Berne, Switzerland.

Diana van Riet is a senior assessor at the Medicines Evaluation Board in the Netherlands (MEB) and a member of the European Medicines Agency Quality Working Party. She has a PhD in pharmaceutical technology and pharmacoepidemiology and is licensed as a pharmacist. Diana has great interest in patient centric drug development and has for example been rapporteur for the guideline on the pharmaceutical development of medicines for paediatric use or the reflection paper on the pharmaceutical development of medicines for older people.

Paul Varley, Ph.D., is Vice President, Biopharmaceutical Development at MedImmune Ltd., Cambridge (formerly Cambridge Antibody Technology, CAT). Paul is chair of the Advisory Board of the CPI UK National Centre for Biologics Manufacture and a member of the University College London EPSRC Centre for Innovative Manufacturing of Emergent Macromolecular Therapies. Paul is a member of the British Pharmacopoeia (BP) Commission, and Chair of BP Expert Advisory Group on biological and biotechnological products. He is also a member of the EP Expert Committee on Monoclonal Antibodies and a member of BP panel of experts for Blood Products.

Dr. Bassil Akra is CEO & one of the owners of QUNIQUE, a medical device & in-vitro diagnostic consultancy company. He spent the last decade as a subject matter, represented locally and globally the notified body association in the various European discussions. Previously Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He trained and educated various stakeholders at TÜV SÜD on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

Mihaela is a chemist who received a PhD in pharmaceutical chemistry from the Ruprecht-Karls University (Heidelberg, Germany). Following post-doctoral research at the Institute for Pharmacy and Molecular Biotechnology (Heidelberg), she joined the Institute for Reference Materials and Measurement of the Joint Research Centre/European Commission, where she was responsible for the development and certification of biological reference materials. In March 2013, Mihaela joined the European Directorate for the Quality of Medicines & HealthCare (Council of Europe, Strasbourg). She is a Scientific Programme Manager in the European Pharmacopoeia Department, with responsibility for a number of Expert Groups including the P4Bio and MAB Working Parties.

Dr. Catsoulacos is a pharmacist with a Pharm.D in Clinical Pharmacy and a Ph.D in Pharmaceutical Chemistry. He also holds postgraduate diplomas in Business Administration and Healthcare Management. He started his career as a clinical pharmacist in New York but he soon moved to academia, performing research on novel anticancer compounds. He worked in pharmaceutical industry in the area of R&D of delivery systems. For the last 15 years he has been working for regulatory bodies and international organizations. More specifically before joining the WHO, he served as a quality assurance specialist in UNICEF Supply Division, as a scientific administrator at the EMA and as a senior GMP/GLP inspector in National Organization for Medicines, Greece.

Nancy is a regulatory affairs professional with 18 years of continuous advancement and expertise in registration activities. Knowledge of global CMC, clinical, non-clinical and labelling requirements for vaccines, as well as registration procedures. Nancy was Head of Global CMC Regulatory Affairs at GSK Vaccines, and afterwards she became Global Regulatory Lead for the meningococcal franchise. Nancy joined MSD in 2016 as Sn Director, supporting and coordinating regulatory intelligence activities for vaccines in Europe, and regulatory liaison & strategy work for vaccines and other biologicals. Nancy holds a Bio-engineering Master degree from the Leuven University (Belgium) followed by a PhD degree, and a Master in Intellectual Property.

Martin graduated in engineering with an honours degree from the University of Bath in the late 1970’s. After working through a classical graduate engineering apprenticeship and a few positions in industry, he became the R&D European Group Leader for Kraft Foods in relation to new process automation and processing techniques. After a few years at Kraft, Martin decided to set up a process automation business with a colleague, Dave Richards, and Optimal was born (1987). Optimal Industrial Technologies is a market leader in the field of PAT with its product – synTQ. Martin is intimately involved with progressing the evolution of synTQ. Over the last few years he has also taken on the overall responsibility for the sales and marketing of synTQ.

Jeff Gardner is President & Principal Consultant at DataPharm Statistical & Data Management Services in Cleveland, USA. The company focuses on providing pharmaceutical and biotech manufacturers with consulting services including statistical analysis, custom business software development, and data quality management. Jeff has over 15 years of expertise in applying statistical methods to ensure product quality, and has worked in this capacity for multiple companies including Abbott, Amgen, and Boehringer Ingelheim. An avid SAS programmer, Mr Gardner has also developed and validated GxP-compliant applications for automating data collection, analysis, and reporting. He holds a BS in Mathematics from Marquette University in Milwaukee, Wisconsin.

Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the Technische Universität München (Munich), Germany. He has over 20 years industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 15 years he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early- and late-stage development, and in 2011 he took on the responsibility as EU Lead CMC Regulatory Policy for Roche Pharma Global Technical Operations. Markus is based in Basel, Switzerland. He is currently Chair of EFPIA's Manufacturing and Quality Expert Group (MQEG), EFPIA topic lead for ICH Q12 and CoLead of EFPIA's PRIME/BT/Covid CMC team

Jens Peter Gundorf has for 31 years served in more positions in the company, and the latest in ‘Corporate Quality’ as validation process expert and Validation Focus Group Chairman. His background covers ‘Management of People & Budget’ including responsibility for organisation, finance, clients and business. With an education as chemical engineer and experiences from organic chemistry industry and a brewery the first position was in Automation Engineering Department, where design and construction and validation of solutions for biotechnological and pharmaceutical API processes were the main deliverables.

Luther Gwaza holds a Bachelor of Pharmacy (honours), a Master of Philosophy (MPhil) in pharmacology, and a PhD in Pharmaceutical Policy and Regulation. He is currently a Technical Officer in the Regulatory Systems Strengthening (RSS) Team in the World Health Organization (WHO), Geneva. His responsibilities include all aspects related to the Collaborative Registration Procedure and other facilitated registration mechanisms. Previously, he worked as a consultant regulatory officer for the national medicines regulatory authority (NRA) in Zimbabwe. He has consulted for various international organizations such on systems strengthening, harmonization, collaboration and cooperation in medicines regulation in Africa and Asia.

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

Prof. Dr. Martin J. Hug is chief pharmacist at the Medical Center and Professor at the Institute of Pharmaceutical Sciences – University of Freiburg, Germany. Prof. Hug received his training at the University of Freiburg, where he received a Ph.D. degree. After appointments as assistant professor at the Institute of Physiology in Freiburg, the Department of Cell Biology and Physiology, University of Pittsburgh Medical Center and the Institut of Physiology II, University of Münster, Martin Hug worked as head of laboratory at Aventis Pharma. In 2003 he joined the staff of the hospital pharmacy in Freiburg. Martin Hug is an active member of the German Society of Hospital Pharmacists and has been working on several aspects of medication safety.

Piotr Krauze joined the EMA inspections sector in 2004 to coordinate GMP inspections, work on MAAs, renewals and variations and to manage quality defects of centrally authorised products. In 2011 he took over tasks related to international agreements and cooperation on GMP. Between April 2017 and April 2018 he was working at DG SANTE dealing mainly with international agreements (e.g. with USA, Japan and Canada) and shortages of medicines. Piotr has an MSc in Chemical Engineering, Biochemistry, Biotechnology and Food Chemistry and Technology from the Vienna University of Technology. Prior to joining the EMA he worked at Boehringer Ingelheim Austria, covering the areas of production, automation, qualification, validation and GMP compliance.

Thomas Lang is biostatistician by training. He spent eight years in academic research, followed by three years in clinical research in the pharmaceutical industry. He currently works as senior statistical assessor for the Austrian Agency for Health and Food Safety. For more than nine years he was a member of the Scientific Advice Working Party at EMA. In his current role of a member of the Biostatistics Working Party, Thomas acted as rapporteur for the EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

Nick has a PhD in physico-organic chemistry, and he started his career in Industry developing and implementing NIR applications in primary and secondary manufacturing. Since then, Nick has been involved in a number of organisations in different sectors (originator-generics-CRO; devices-combination products-medicinal), in increasingly senior roles, culminating as R&D Director for a small biotechnology company in Ireland. In his role at the HPRA, he has responsibility for assessment of many procedure types including CAPs, CTAs and EMA/national Scientific Advice. As well as being HPRA lead for Continuous Manufacturing and departmental lead for Drug-Device Combination products, Nick is currently ICH Q13 EC/Europe Topic Lead and vice-chair QWP

I am a Senior Director at Lonza Pharma and Biotech Operations organization since Aug 2017 responsible for Global Technical Functions such as QC, MSAT, Engineering & Maintenance, Contamination Control, Tech Transfer and Single-Use Systems. My previous experience is at Baxter with roles of increasing responsibility in the areas of Global Quality Control, Clinical Product Manufacturing, Tech Transfer, and facility start-ups from July 2002 to June 2016. I also ran the Global Analytical Development group from July 2016 to July 2017 at Shire. I am a chemist by training with a PhD from the Technical University of Vienna and a MSc from the University of Helsinki.

Ingo Matthes studied pharmacy at the Friedrich Alexander University in Erlangen. After getting his license as pharmacist he made his PHD at the University of Basel in the range of biopharmacy. He started his professional career first in the pharmaceutical industry at Ciba Geigy and Novartis within pharmaceutical development holding various positions as lab-head, pilot plant manager and project leader. In 2009 he joined Swissmedic as quality reviewer and unit head of the Division Quality Review. Since 2016 he is head of the Division Quality Review within the Sector Marketing Authorisation of Swissmedic.

Isabel Menz is managing director of the medHF subsidiary in Germany. She has an educational background in psychology and human factors engineering and has worked as a Human Factors expert in medical product development throughout her career. Isabel has experience with a variety of medical products, ranging in complexity from pill dispensers to surgical robots, and all stages of product development. She has previously worked at Cambridge Consultant and GfK and has started at medHF in 2017, building a German base for expert Human Factors services in medical products.

Gordon is Visiting Professor of Pharmaceutics, Leicester School of Pharmacy at De Montfort University, with research interests in the practical application of a Rapid Adaptive Continuous development and commercial manufacturing platform, underpinned by QbD and PAT. He is also President of GMPharma, a Pharmaceutical Consultancy. He has worked in senior global roles in the Pharmaceutical Industry for over 30 years. Previously, he was VP of Global New Medicines Introduction within the Manufacturing division of GSK. In this time GSK launched a significant number of new medicines, combination medicines, and inhaled drug-device combinations. Gordon is also a Fellow of the RPS, an Associate Fellow of the IChemE and is active in STEM initiatives.

Morten Munk’s career is comprised of 30 years of experience within the global biopharmaceutical industry. One common denominator for his work has been to ensure a holistic and broad perspective on biomanufacturing challenges from idea to established facilities. His key focus is to ensure compliant and cost-effective production through the optimal use of all relevant and available knowledge and technologies, such as single-use systems and continuous processing. Morten joined NNE as Global Technology Partner in 2015. In 2001 he co-founded CMC Biologics, after working 14 years at Novo Nordisk.

Ron is a process chemist by training and joined Pfizer in 1990 in Chemical Process R+D. After 10 years’ experience in CRD, Ron joined Pfizer Regulatory CMC in 2001. He works in Sandwich in the UK and is now an internal CMC advisor within Pfizer.

James Pound joined the British Pharmacopoeia in 2008. He has worked in a variety of roles within the BP including responsibility for medicinal chemicals, digital & publications and veterinary medicines. In addition to this he initiated and has led the joint BP and MHRA AQbD feasibility study and working party. He was promoted to Group Manager British Pharmacopoeia & Laboratory Services in 2017. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for both multinational pharmaceutical manufacturers and independent UK analytical laboratories.

Lionel graduated in Biochemistry/Biophysics and post graduated in Quality Management and Control of Pharmaceuticals. He has 23 years of experience within Pharmaceutical industry of which 10 years were devoted to the analytical development and quality control. Since 2008, as Director, he has taken over CMC regulatory responsibility for Clinical Development and Life Cycle Management of pharmaceutical products worldwide. He was recently appointed as Head of CMC Regulatory Intelligence in GRA at Merck. He is EFPIA Topic Lead for ICH Q4B Annexes and member of EBE’s Biomanufacturing working group. He is also a member of the EDQM MAB Working Party as well as BP Expert Advisory Group on biological and biotechnological products.

Marc received his Master Degree in English and Biology from Ruhr-University Bochum and PhD from Heinrich-Heine-University Düsseldorf in Pharmaceutical Technology. He joined the medical device industry in 2001 as a Project Manager in Regulatory Affairs for Respimat® Soft Mist Inhaler with STEAG microParts GmbH. He held several positions in the development of inhalation devices and their formulations for Boehringer Ingelheim companies. In 2010 he joined their Biopharma Division as a Senior Manager Technology & Innovation Delivery and took over the position as the Head of Device/Combination Product Development for biopharmaceuticals in 2014. In 2017 Marc joined Novartis as Head New Technologies in TRD Device Development and Commercialisation.

Non-clinical statistician at Arlenda with an experience of more than 15 years in the statistical aspects related to bioassays and analytical methods robust optimization, validation, transfer, inter-laboratories studies, uncertainty assessment...as well as processes optimization, QbD and Design Spaces implementation, statistical process control and Design of Experiments. Active member of the French Society of Pharmaceutical Sciences and Techniques (SFSTP) Commissions on “Analytical Methods Transfer” and on “Methods Validation”. Trainer for analysts of the Pharmaceutical Industry on topics such as validation, robustness and transfer of analytical methods. BSc in Bio-engineering, a PhD in Pharmaceutical Sciences and a Master in Biostatistics.

Patrick is Chief Technology Officer of EXPUTEC with responsibility for scientific developments, technical innovations and business development. Patrick joined EXPUTEC in 2013. He studied technical chemistry in Graz and Vienna, Austria. Patrick received his PhD in biochemical engineering from the Technical University of Vienna. His research profile includes bioprocess development, mathematical modelling of biochemical systems and applied statistics.

Prof. Dr. Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology. At Capsugel, Sven has worked as an advisor to major pharmaceutical companies on ways to improve the design, development and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, he focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies. He is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as founder and president of the Geriatric Medicine Society.

The role of Process Management within Product and Process Development is to lead technical activities during co-development and tech transfer of new solid oral dose products at the Pfizer, Freiburg site. The primary goal of Co-Development is to ensure efficient product development combined with successful commercial manufacturing by involving manufacturing early in the drug development process. Christoph has been involved in a number of new product launches and innovative technology and regulatory initiatives (e.g. piloting QbD/Design Space, implementation of continuous manufacturing technology). He is a pharmacist with a PhD in Pharmaceutical Sciences from Friedrich-Alexander University, Germany, and an MBA from University of Reading, UK.

Christian is Senior Director Global Accounts at Werum IT Solutions, part of Körber Medipak Systems Group. Werum is the market leader in Manufacturing Execution Systems/MES Solutions for Life Science industries, working for 17 of the Global Top 30 Pharma Companies with more than 800 installations. He holds a Master Degree in Mechanical Engineering. Since more than 25 years working in Life Sciences Manufacturing IT, he has had great experience in all GMP related processes. He has broad activities inside the ISPE as Chairman of the Special Interest Group “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, “Knowledge Network Council” Co-Chair, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member.