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DIA CMC Workshop


  • Yasmin  de Faria Krim, PharmD, MSc

    Yasmin de Faria Krim, PharmD, MSc

    • Chair, CMC Working Group, DIA Regulatory Affairs Community, France

    Yasmin de Faria Krim is chairperson of the CMC working group within the DIA Regulatory Affairs Community.

  • Ursula  Busse, PhD, MBA

    Ursula Busse, PhD, MBA

    • Head of Quality Intelligence, External Engagement
    • Novartis, Switzerland

    Ursula currently holds a global position as Head of Quality Intelligence in Group Quality External Engagement at Novartis. She drives the Novartis external engagement strategy in quality, technical and regulatory topics and leads global GxP regulatory intelligence. Prior to her current role, Ursula held leadership roles in CMC Regulatory Affairs for biologics and Biopharmaceutical Operations. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in R&D, Quality Assurance and CMC Regulatory Affairs. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Canada), coupled with an MBA she earned with honors.

  • Sabine  Kopp, PhD

    Sabine Kopp, PhD

    • Group Lead, Medicines Quality Assurance
    • World Health Organization (WHO), Switzerland

    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, PhD

    Frank Montgomery, PhD

    • Global Head, Regulatory CMC, GRAPSQA
    • AstraZeneca, United Kingdom

    PhD in Synthetic Organic Chemistry. Frank worked in technical roles for Ciba Geigy in discovery then AstraZeneca CMC development and commercialisation. 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 has presented at a number of International conferences on implementation of QbD including DIA, ISPE, PDA and more recently a major EMA/EFPIA workshops on learning from implementation of ICH Q8-11 and opportunities for ICH Q12. Frank is a member of ICH Expert Working Group (EWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

  • Elaine  Morefield, PhD, RPh

    Elaine Morefield, PhD, RPh

    • Vice President, Regulatory Affairs
    • VaxForm, LLC., United States

    Dr. Elaine Morefield is the Vice President, Regulatory Affairs for Vaxform,LLC. where she provides regulatory and development consulting services to clients. 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.

  • Moheb M. Nasr, PhD, MS

    Moheb M. Nasr, PhD, MS

    • Principal
    • Nasr Pharma Regulatory Consulting , United States

    Dr. Nasr is responsible for the development and the execution of CMC regulatory strategy at GSK. Prior to joining GSK, he spent over 22 yrs at FDA and established and led the Office of New Drug Quality Assessment (ONDQA). Dr. Nasr was instrumental in the development of QbD concept and several ICH guidelines and continues to play a leading role in global regulatory harmonization. Dr. Nasr is currently the rapporteur of ICH Q12

  • Peter  Richardson, PhD

    Peter Richardson, PhD

    • Head of Quality, Specialised Scientific Disciplines Department
    • European Medicines Agency (EMA), European Union, United Kingdom

    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.

  • Jean-Louis  Robert, PhD

    Jean-Louis Robert, PhD

    • Former CHMP/CVMP QWP Chair
    • Luxembourg

    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  Barry, PhD

    Sean Barry, PhD

    • Executive Pharmaceutical Assessor
    • Health Products Regulatory Authority (HPRA), Ireland

  • Andrew  Chang, PhD

    Andrew Chang, PhD

    • Vice President, Quality and Regulatory Compliance, QI&I, Corporate Quality
    • Novo Nordisk A/S, United States

    Dr. Chang has more than 20 years of experience in the development, regulation and quality of biologics and pharmaceuticals. As Vice President, Quality and Regulatory Compliance, Quality Intelligence and Inspection, Novo Nordisk, he is responsible for external affairs, providing strategic advice and solutions for quality and regulatory related issues, and expert support to inspection preparation. He is representing PhRMA as an expert to ICH Q12 EWG for developing guideline on Pharmaceutical Products Lifecycle Management. Prior to Novo Nordisk, Andrew served more than 11 years at US FDA, most recently as an Associate Director for Policy and Regulation, Acting Deputy Director and Senior Regulatory Scientist in the Division of Hematology, CBER.

  • Oliver  Schläfli

    Oliver Schläfli

    • Global Head, BTDM Quality
    • Novartis, Switzerland

  • Diana  van Riet-Nales, PharmD, PhD

    Diana van Riet-Nales, PharmD, PhD

    • Senior Assessor; Member of EMA Quality Working Party
    • Medicines Evaluation Board (MEB), Netherlands

    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, PhD

    Paul Varley, PhD

    • Vice President, Biopharmaceutical Development (Cambridge) Site Lead
    • MedImmune Ltd., United Kingdom

    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.

  • Bassil  Akra, PhD

    Bassil Akra, PhD

    • Vice President, Global Focus Teams (Cardiovascular, Orthopedic and Clinical)
    • TÜV SÜD Product Service GmbH, Germany

    Dr. Bassil Akra is the vice president of global focus teams (Active Implantable, Cardiovascular, Orthopaedic and Clinical) at TÜV SÜD Product Service. Dr. Akra has long experience in R&D, quality management and regulatory approval of medical devices, combination devices and ATMP products. He is a member of the clinical investigation and evaluation working group and is representing Team NB and NB MED in various European discussions and task force activities regarding clinical and post-market requirements such as MEDDEV and PSUR. Dr. Akra is a member of the German MDR Implementation Working Group.

  • Dimitrios  Catsoulacos

    Dimitrios Catsoulacos

    • Technical Officer - Expert Inspector
    • World Health Organization (WHO), Switzerland

  • Nancy  Cauwenberghs

    Nancy Cauwenberghs

    • Senior Director Regulatory Affairs, Global Regulatory Affairs & Clinical Safety
    • MSD, Belgium

  • Brendan  Cuddy

    Brendan Cuddy

    • Head of Manufacturing and Quality Compliance
    • European Medicines Agency (EMA), European Union, United Kingdom

    Brendan Cuddy joined the EMA in 2002. In 2014 he was appointed Head of MQC Service, which is responsible for inter alia, co-ordination of GMP inspections, assessments of quality defects and product recalls, and sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chair and secretariat of the GMDP IWG and the secretariat for the Quality Working Party.

  • Martin  Gadsby

    Martin Gadsby

    • Owner & Director
    • Optimal Industrial Automation Ltd, United Kingdom

  • Jeff  Gardner

    Jeff Gardner

    • Principal Consultant
    • DataPharm SDMS, LLC, United States

  • Markus  Goese, PhD

    Markus Goese, PhD

    • Lead EU CMC Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Markus Goese holds a Ph.D. in Biochemistry/ Organic Chemistry from the Technische Universität München (Munich), Germany. He has more than 17 years industry experience in various companies (Roche, DSM, Novartis) in Pharmaceuticals and Fine Chemicals Research, Development and Commercialization. For the last 11 years he has been working in CMC Regulatory Affairs, initially on Biopharmaceutical Products in early and late-stage development; he then took on the responsibility as the Lead for EU CMC Regulatory Policy for Roche Pharma Global Technical Operations in 2011. Markus is based in Basel, Switzerland. He is currently the Chair of EBE’s Biomanufacturing working group and the EFPIA deputy topic lead for ICH Q12.

  • Jens Peter Gundorf

    Jens Peter Gundorf

    • Principal Validation Specialist
    • Novo Nordisk A/S, Denmark

    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, PhD

    Luther Gwaza, PhD

    • Technical Officer
    • World Health Organization (WHO), Switzerland

  • Christoph  Herwig, PhD

    Christoph Herwig, PhD

    • Professor, Institute of Chemical Environmental and Biological Engineering
    • Vienna University of Technology, Austria

    Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to entering his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design of biopharmaceutical facilities. Since 2008, he is full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of methods for integrated, science-based and efficient bioprocess development along PAT and QbD principles. The product fields are circular economy and biopharmaceuticals within industry driven projects.

  • Kowid  Ho, PharmD

    Kowid Ho, PharmD

    • Pharma Technical Regulatory Policy
    • F. Hoffmann-La Roche Ltd, Switzerland

    Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for 4 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.

  • Sarah  Hockey

    Sarah Hockey

    • Global Head, ESO Systems and Compliance Oversight
    • Novartis, Germany

  • Martin  Hug, PhD

    Martin Hug, PhD

    • Professor, Director of Pharmacy
    • University Medical Center Freiburg, Germany

  • Thomas  Lang, MSc

    Thomas Lang, MSc

    • Senior Statistical Assessor
    • Austrian Agency for Health and Food Safety (AGES), Austria

    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  Lee, PhD

    Nick Lee, PhD

    • Executive Pharmaceutical Assessor
    • Health Products Regulatory Authority (HPRA), Ireland

  • Maria  Loeflund

    Maria Loeflund

    • Head Global Technical Functions/Operations, BU Operations
    • Lonza AG, Switzerland

  • Manfred  Maeder, PhD

    Manfred Maeder, PhD

    • Head of Device Development & Commercialization
    • Novartis, Switzerland

  • Ingo  Matthes

    Ingo Matthes

    • Head of Division Quality Review
    • Swissmedic, Switzerland

  • Isabel  Menz, MSc

    Isabel Menz, MSc

    • Managing Director Germany
    • Medical Human Factors GmbH, Germany

    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  Muirhead, PhD

    Gordon Muirhead, PhD

    • Visiting Professor of Pharmaceutics
    • Leicester School of Pharmacy at De Montfort University, United Kingdom

  • Morten  Munk

    Morten Munk

    • Global Technology Partner, Global Best Practice
    • NNE A/S, Denmark

    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.

  • Roger  Nosal, PhD

    Roger Nosal, PhD

    • Vice President, Global CMC
    • Pfizer Inc, United States

    Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. He is currently the PhRMA Topic Leader for ICH M9, Chair of ISPE Pharmaceutical Engineering and co-chair of ISPE Regulatory Track and DIA Quality Program Committees.

  • Ron  Ogilvie

    Ron Ogilvie

    • CMC Advisor
    • Pfizer, United Kingdom

  • Lionel  Randon

    Lionel Randon

    • Head – GRA CMC Regulatory Intelligence & Ops
    • Merck Serono, Switzerland

    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.

  • Sven  Stegemann, PhD

    Sven Stegemann, PhD

    • Professor of Patient Centric Drug Development and Manufacturing
    • Graz University of Technology, Austria

    Sven Stegemann is a pharmacist and holds a PhD in pharmacology. His scientific interest is in improving drug therapy in older adults through multidisciplinary and patient centered science. He founded the Geriatric Medicines Society supported by industry, academia and regulatory authorities.

  • Christian  Wölbeling

    Christian Wölbeling

    • Senior Director
    • Werum IT Solutions GmbH, Germany