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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe Quality and Regulations

9-11 June 2020, online

  • Barbara Allen, PhD

    Eli Lilly & Company
    Barbara Allen, Ph.D. is Senior Director for Global Quality Systems for Eli Lilly and Company.

    Dr. Allen joined Eli Lilly and Company in 1991 in Ireland and has since held various assignments in API Manufacturing Technical Services, New Product Introduction, Quality Assurance, and Global Quality Systems, in Ireland and in the USA.

    In 2002, she began her current position in Global Quality Systems, where she is responsible for providing quality systems for Lilly manufacturing and for ensuring that Quality Systems are integrated across the corporation.

    Dr. Allen was a member of ICH Q10 EWG (Expert Working Group) representing PhRMA and currently serves as a member of IFPMA RPTS.

  • Frank Hallinan

    Frank Hallinan, Prof., PhD

    Consultant

    Frank is an accomplished Quality Management Professional with over 30 years of global experience in the biopharmaceutical industry. He has served as the CEO of the Irish Medicines Board (IMB) and worked in senior management roles in Quality, Regulatory Affairs and Analytical Development with Schering-Plough, Wyeth/Pfizer and most recently as SVP/Global Head of Quality with Jazz Pharmaceuticals. This included 7 years as the site Quality Head through the startup of the major Pfizer Grange Castle, Ireland facility.

    As an international consultant, Frank has assisted several organisations (public and private) in various countries in understanding current biopharmaceutical quality requirements, in managing deviations, investigations, corrective & preventive actions, and change controls, and in implementation of a Quality System aligned with Q9 and Q10.

    Frank served as the Founding President of the Ireland chapter of PDA from 2005 to 2007 and led the organization of a joint PDA/IMB meeting at the Dublin ESOF 2012 meeting on the topic of Advanced Therapies.

    Frank is qualified as a QP through a Post Graduate Diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin. He holds a BSc in Biochemistry and a Ph.D. in Cell and Molecular Biology from UCC, Cork, Ireland and the University of Southampton, UK, respectively, and is currently an adjunct Professor at the School of Pharmacy of UCC, Cork.

  • Karin Baer

    Karin Baer

    Boehringer-Ingelheim

    Karin Baer has more than 25 years of experience in the Quality field. She holds her Degree in Chemistry and Biochemistry from the Hebrew University, Jerusalem, Israel.

    Karin worked for Teva Pharmaceutical Industries, Pharmaceutical Operations Division in many different positions for many years, in her last role as VP Quality-Regional Manager.

    In 2018, Karin joined Boehringer Ingelheim as Head of Global Quality Assurance.

    Karin is a courageous Quality Leader with lots of broad experience and the ability to motivate people. She was born and grew up in Switzerland, then moved to Israel, and now works in Germany.

  • Vinny Browning

    Vinny Browning III, PhD

    Amgen

    As the Executive Director of Commercial Attributes Sciences, Vinny oversees the day to day support of methods being transferred, validated, and executed at Amgen’s Commercial sites. He is also accountable for forensics in support of consumables, raw materials, and process as well as Data Sciences and Engineering Team who proactively monitors Amgen’s process, product, and method data.

    In his previous role, he was the QC Global Network Leader, QC Global Process Owner, and Director of the QC Center accountable for setting the overall QC Testing Strategy for the company and ensuring alignment from a regulatory perspective across QC.

    Vinny has held several different roles over his 22 year career, including Site Head of our Testing and Research Facility in the U.K., Director of QC Bioanalytics, Sr. Manager of Contract Testing, Critical Reagents, and Raw Materials Laboratories, as well as a QC Bioanalytical Testing Analyst.

  • Karen Casey

    Karen Casey

    Janssen J&J

    Karen Casey is the Senior Manager for Quality Assurance at the Janssen Supply Chain Small Molecule API site in Cork, Ireland.

    Karen joined Janssen in 2005 and has since held various roles across Technical Operations, Manufacturing and Quality.

    She has held a number of global supply chain roles across Janssen Supply Chain, including leading Global management review and metrics across the supply chain and supporting reliability initiatives. Karen is a new member to PDA since 2019.

  • Graham Cook

    Graham Cook, PhD

    Pfizer

    Graham leads Pfizer’s Global Quality Intelligence and Compendial Affairs group. He is the chair of Efpia’s Technical Development Group (TDEG) and is the Efpia Topic Lead for ICH Q12 Product Lifecycle Management. He was appointed to the British Pharmacopoeia Commission in 2010 and chairs the MC2 Expert Advisory Group and AQbD Working Party.

    Between 2012-2018, he was Chairman of the ASTM International E55 Technical Committee developing pharmaceutical manufacturing standards and continues to serve as a member of the E55 Executive Committee. He is a past chair of Pfizer’s QbD Council, and previous roles include Technical Director supporting Wyeth Europa Manufacturing and External Supply, and Director Formulation Development for Wyeth Consumer Healthcare (Richmond, VA). Graham is a pharmacist with a Ph.D. in pharmaceutics.

  • Patrick Costello

    Patrick Costello

    AbbVie

    Patrick Costello is a Director of QA with Abbvie Inc where he manages a team responsible for global regulatory reporting, quality management review and data analytics.

    He has expertise in Advanced Therapies, Blood, Tissues and Cells. Previous to Abbvie, Patrick worked for 4.5 years at the European Medicines Agency as a Scientific Administrator responsible for management of shortages, quality defects and recalls.

    Prior to EMA, Patrick worked for 13 years at the Health Products Regulatory Authority as a senior inspector charged with implementation of European legislation on Blood, Tissues and Cells, Organs and ATMPs.

  • Falk Klar

    Falk Klar, PhD

    PDA Europe

    Falk Klar holds a PhD in Applied Physics and has more than 19 years of experience in Quality Assurance and Compliance. Before joining PDA Europe, he worked for the pharmaceutical, biopharmaceutical, and medical device industries, and in clinical research.

    Falk joined PDA Europe in 2015 as Senior Director Training & Education. He will develop and extend PDA Europe’s portfolio of training courses and workshops for the parenterals market. Recently, he was appointed General Manager and Vice President PDA Europe.

  • Toni Manzano

    Toni Manzano, PhD

    Bigfinite

    Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

  • Ruth Miller

    Ruth K. Miller, JD

    PDA

    Ruth K. Miller is the Director of Regulatory Affairs for PDA. She manages the activities of PDA’s Regulatory and Quality Advisory Board, leading the team in shaping regulatory and policy documents globally. She is PDA’s primary point of communication with regulatory and policy bodies around the world.

    Before joining PDA, Ruth served in legal and regulatory roles covering the entire scope of the pharmaceutical supply chain. She was the Senior Director of Regulatory Affairs for a drug wholesaler trade association, working to impact U.S. federal and state regulations relating to the safe movement of pharmaceuticals, foods, and medical devices. She also has served as a regulatory and administrative law attorney in the U.S. Drug Enforcement Administration (DEA) Office of Chief Counsel; as Senior Counsel for the U.S. Pharmacopeia; and as an Associate in the food and drug practice of Covington & Burling, LLP, in the law firm’s Washington and London offices.

    Ruth holds a BA from The College of William and Mary in Virginia and a JD magna cum laude from the Boston University School of Law, where she was Executive Editor of the American Journal of Law and Medicine.

  • Mihai Bilanin

    Mihai Bilanin, PhD

    GSK Vaccines

    Mihai Bilanin has spent over 17 years in the pharmaceutical industry, with the last 15 years (6 years at GSK Vaccines) in Global Regulatory Affairs in Canada and Europe. He has managed worldwide regulatory projects in development, registration and life-cycle management (various degrees of complexity), primarily in pharma, and for the last 6 years, in vaccines in a CMC Regulatory function. Latterly Mihai has focussed on regulatory matters related to the Quality by Design approach and ICHQ12, in additional to managing a team of Regulatory CMC writers.  He currently works for GSK Vaccines and is based in Belgium.

  • Ashley Boam

    Ashley B. Boam, MSBE

    U.S. FDA

    Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.

    Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.

  • Jette Christensen

    Jette Christensen

    Novo Nordisk

    Jette Christensen works at Novo Nordisk A/S where she has had several different positions. Currently she is working as Compliance Specialist in the Diabetes Finish Product section. Jette works with sites located in Denmark, France, USA, Brazil and China and has a global view on authority requirements, manufacturing processes and culture.

    Jette has been an active PDA member since 1998 and has been involved in several activities. She has presented at several conferences and has been member of PDA planning committees and task forces; currently Jette is involved in the PtC Aseptic Processing and the Sterile Manufacturing GMP Comparison task forces. Furthermore, Jette is member of PDA Science Advisory Board and Board of Directors.

  • David Churchward

    David M. Churchward, MSc

    MHRA

    David is Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector) for the Medicines and Healthcare products Regulatory Agency (MHRA).

    He has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate.

    He is experienced in leading the implementation of innovative regulatory approaches and provides GMP input to the MHRA’s Innovation Office for new products and technologies.

    David has extensive involvement in international regulatory harmonisation and collaboration as a member of the PIC/S Executive Bureau and Committee of Officials, sub-committee for GMP Harmonisation and delegate to the ICH Assembly.

  • Richard Friedman

    Rick L. Friedman, MS

    FDA

    Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER).  This position includes oversight of regulatory action recommendations relating to inspections and manufacturing site acceptability, and promoting sound regulatory policy development.  Mr. Friedman has authored several publications on topics including sterile drugs and quality systems.  Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s  QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.

  • Robert Gaertner

    Robert Gaertner

    Veeva Systems

    Robert Gaertner is Director of Strategy for Quality at Veeva Systems in Europe. With more than 20 years of experience in the life sciences industry, he has a deep understanding of processes and systems in GxP-related areas. Starting his career at Fresenius Kabi, Robert moved to a large consultancy and led large quality implementation programs, including eDMS, eQMS and LIMS for a number of Life Sciences organizations.

    As a Subject Matter Expert and Industry Consultant, Robert has worked for leading companies including PwC Consulting, IBM, Lodestone, and Infosys. In his current role at Veeva, Robert is leading Veeva’s strategic activities for Quality & Manufacturing in Europe.

  • Beth Haas

    Beth J. Haas, MChE

    Commissioning Agents, Inc.

    Beth has focused much of her 28 year career performing new product introductions and technology transfers. She has commercialized 20+ products across a variety of industries including small molecule APIs, drug product, specialty chemicals, thin film, and commodity chemicals Using her knowledge of ICH guidances, she enjoys helping both large pharma and virtual companies identify key focus areas for product development, transfers, and scale-up. Her in-depth understanding of criticality enables her to guide organizations in defining accurate critical quality attributes, critical process parameters, and critical aspects for process equipment and laboratory systems. Beth joined the PDA Technology Transfer Interest group in 2015 where she has focused on building a generic tool for guiding technology transfer program management and most recently, worked with PDA on a wide ranging survey on Technology Transfer. She wants to build the PDA TT IG community with cross-functional expertise where knowledge on technology transfer strategies and best practices can be shared.

  • Ghada N. Haddad, PhD

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and a PhD and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Anne Hayes

    Anne Hayes

    HPRA, PIC/S

    Anne has been working with the Health Products Regulatory Authority for 20 years. As Inspection Manager, she has responsibility for inspection programmes relating to Good Manufacturing Practice, medical device auditing, Good Clinical Practice, Good Pharmacovigilance Practice and Good Practice in relation to blood, tissues, cells and organs for transplantation.

    Anne is currently the PIC/S Chair for 2020 & 2021.

    Before joining the HPRA, she worked in the pharmaceutical industry for five years as a QC Supervisor and as a qualified person (QP).

  • Richard Johnson

    Richard Johnson, MS

    PDA

    Richard M. Johnson was named President and CEO of the Parenteral Drug Association in September 2009. Richard has been an active member of PDA, serving on the Scientific Advisory Board (co-chair); Regulatory Affairs Quality Control committee; Sterile/Aseptic Processing Interest Group (chair); Aseptic Processing committee (co-chair); GMP and Glass Defects (Chair) Task Forces. In his more than 30 year career in the pharmaceutical and medical devices industry, Richard has been a recognized leader with excellent knowledge of US and international regulatory requirements, quality practices, and technical operations, especially in validation, sterilization, aseptic and sterile processing. Prior positions include Vice President of Global Quality Assurance for Fort Dodge Animal Health (a division of Wyeth), Director of the Corporate Quality Center of Excellence for Abbott Laboratories, and both US and International assignments with Alcon Laboratories and Bausch & Lomb.

    Richard has M.Sc. and B.Sc. degrees in Biological Sciences from Marshall University. He was also the co-chair of the US Sub-TAG to ISO/TC 198 (Aseptic Processing), and has been active in the PhRMA Bar Code Committee, PQRI Aseptic Processing Working Group, ISPE and the Midwest Quality Discussion Groups since the early 1990s.

  • Maura Kibbey

    Maura Kibbey, PhD

    United States Pharmacopeia

    Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department.

    Dr. Kibbey leads development of courses, workshops, and forums to engage USP’s biologics stakeholders. This role builds on her previous responsibilities directing USP scientists developing compendial standards.

    Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health.

    She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

  • Padraig Landers

    Padraig Landers

    Bristol-Myers Squibb

    Padraig Landers is Site Quality Director at the BMS Cruiserath Biologics site in Dublin, Ireland.

    Padraig joined BMS in 2016 and has held various roles across Manufacturing Technology and Quality during the start-up and commercialisation of the multiproduct cell culture facility.

    Prior to joining BMS Padraig held a variety of technical and manufacturing operations roles in Biopharma across both Drug Substance and Drug Product processes.

  • Martin Marty Lipa

    Martin Lipa

    MSD / TU Dublin

    Martin (Marty) Lipa has over 25 years’ industry experience and 12 years’ experience in Knowledge Management.

    Marty has published several industry specific works and is currently pursuing his Ph.D. at Technological University Dublin in Pharmaceutical and Regulatory Science with a focus on enabling ICH Q10 through improved knowledge management.

    Marty also leads the Knowledge Management Center of Excellence for the Manufacturing Division of Merck & Co., Inc. (Kenilworth, NJ).

    Marty is an active member of the KM community as a regular speaker and writer, and he has helped organize several KM conferences.

  • Oliver Meier

    Oliver Meier

    Novartis

    Oliver is the QA Head Compliance Operations & Projects at Novartis. He is responsible for the independent corporate governance and monitoring of all quality and compliance operation aspects.

    Oliver joined Novartis in 2001 as a Site QA Head. Over the years, he has held roles of increasing responsibility at both local and global levels. Oliver holds a degree in hygiene engineering and has a broad background in QA / GxP compliance, as well as in leading remediation and transformation activities.

    Overall, Oliver has 20+ years of experience within the pharmaceutical QA and QC in Germany, France, Switzerland and the US.

  • Anthony Morandi

    Anthony Morandi

    AstraZeneca

    Anthony has been at AstraZeneca since 2017 and is currently responsible for the company’s Operations Quality strategy and business performance.

    The role includes responsibility for the Pharmaceutical Quality Management System, Issues Management Teams, Global Quality Control, Global Product Stability, Quality Business Performance/LEAN and Quality data analytics and digital systems.

    In his 25+ year professional career he has held roles in Quality and Manufacturing at Amgen, Biogen, Catalent Pharma Solutions and Johnson & Johnson.

  • Lorraine Nolan

    Lorraine Nolan, PhD

    Health Products Regulatory Authority (HPRA)

    Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances.

    Prior to assuming the role of Chief Executive, she was Director of Human Products Authorisation & Registration.

    Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA) and the EU HMA Management Group.

    Ms Nolan was recently appointed to the role as vice-chair of the EMA.

  • Kevin ODonnell

    Kevin O'Donnell, PhD

    HPRA

    Kevin O’Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland.

    He has been with the HPRA/IMB since 2001 and is also a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme.

    Kevin obtained his PhD in Quality Risk Management from the Dublin Institute of Technology in 2008.  He is currently Chair of the PIC/S Expert Circle on QRM.

  • David O'Grady

    David O'Grady, MS

    Sanofi

    David is a technology leader with more than 20 years of experience in biopharma development, technology transfer and commercialization.

    He has extensive experience in the translation of new biopharma products from clinical to full-scale commercialization and lifecycle technical support.

    David holds a degree in Pharmacy and a Masters in Technology Management from the University of Limerick.

  • Emma Ramnarine

    Emma Ramnarine, MS

    Genentech/Roche

    Emma Ramnarine is the Global Head of External Development Collaborations at Genentech/Roche. She leads outsourcing strategies and manages the external clinical development, manufacturing, and clinical collaborations network for Roche’s Biologics and Small Molecules development portfolio.

    Emma has 20+ years of experience in the pharmaceutical, biotechnology and medical device industry in Analytical Science & Technology, Quality Control, Risk Management and Quality System Management. She is a worldwide-recognized expert on Quality Risk Management (QRM), providing QRM training to regulatory authorities and at industry forums.

    Emma is currently on the PDA Board of Directors and is co-leading PDA’s Post Approval Change Task Force.

    She has additionally led several other PDA Task Forces and Technical Reports, and also served on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB).

  • Stephan Roenninger

    Stephan Rönninger, PhD

    Amgen Europe

    Dr. Stephan Rönninger is the 'Head External Affairs Europe, International Quality' of Amgen. He provides leadership, support and represent of external activities impacting Amgen's operations functions. He works with associations in the EU, Japan and emerging markets with focus on Russia and Turkey. He is responsible for advocacy in various external organizations and provides assessment and communication to Amgen.

    Stephan Rönninger holds a PhD and an engineering degree in Organic Chemistry. After his postdoctoral studies, he worked for Roche 1992 - 2013, starting in an API manufacturing site with responsibilities for laboratory, project management, as production manager, in Quality Assurance and Quality Management. In 2003, he changed to the Roche Global Quality organization and was responsible for the Global Quality System of Roche and external collaborations.

    He represents Amgen in industry trade associations (e.g. EFPIA) and the European industry on GMP/GDP topics as well as at ICH working groups such as Quality Risk Management (ICH Q9), Quality Implementation Working Group (Q-IWG), and the GMP for APIs (ICH Q7) Implementation Working Group. In the Parenteral Drug Association (PDA), he is elected for the board of directors, past chair of the Regulatory Affairs and Quality Advisory Board (RAQAB), leader of the PDA-Europe Inspections Trends Interest group and co-chairs several international conferences and training events (e.g. with PIC/S). He is one of the founders and co-chair of the 'Paradigm Change in Manufacturing Operations' (PCMO) project in PDA.

  • Anil Sawant

    Anil Sawant, MSc, PhD

    Merck & Co., Inc. / MSD

    Dr. Sawant has over 25 years of experience in Quality Operations, GXP Compliance Operations, Auditing, and Ethics & Research Integrity functions.

    He has extensive experience working on small molecules, biologics, and vaccines, various dosage forms from injectable to topical, and medical devices and combination products.

    Prior to joining Merck, Dr. Sawant was Vice President, Enterprise Regulatory Compliance, Johnson & Johnson.  Prior to J&J, he served as the Vice President, Compliance & Research Integrity for Wyeth Pharmaceuticals (now Pfizer).

    Dr. Sawant holds a B.Sc. Honors and a M.Sc. Honors in Microbiology from Panjab University, India and a Ph.D. in Microbial and Biochemical Sciences from Georgia State University, Atlanta, GA. He has published numerous papers in peer reviewed microbiology and medical journals on glycoproteins, fermentation, medical device development, and GLP and GCP studies.

    Dr. Sawant has been the lead for four PDA Technical Report and Co-Chairs the PDA Task Force on Data Integrity.

    Dr. Sawant currently serves on the/PDA Board of Directors, Board of Directors Mind Your Brain Foundation and has served on Board of Directors of Georgia State University Alumni Association. He is recipient of the Georgia State University Distinguished Alumni Achievement Award and the PDA Distinguished Service Award.

  • Siegfried Schmitt

    Siegfried Schmitt, PhD

    PAREXEL

    Siegfried provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance.

    Siegfried holds the position of Vice President Technical at PAREXEL Consulting. His areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, for all types of formulations.

    Siegfried is a seasoned and experienced auditor, providing support to clients pre and post inspections or audits. Siegfried has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.

    As an active member of various industry associations, Siegfried is a frequent presenter and committee member of international events. He is also an accomplished author and editor as well as member or chairman of several editorial boards. Dr. Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.

  • Paul Sexton

    Paul Sexton

    HPRA

    Paul Sexton joined the Irish Medicines Board (now Health Products Regulatory Authority) in 2002 as a GMP / GDP inspector. Prior to that he worked in the pharmaceutical industry for 14 years in the areas of regulatory affairs and production.

    He currently holds the position of GMP Policy Manager and is the HPRA representative at the GMP / GDP Inspector’s Working Group Meetings held at the European Medicines Agency.

  • Michele Simone

    Michele Simone

    Bracco Suisse

    Dr. Michele Simone is Director of Corporate Quality Management for Bracco Suisse SA in the pharmaceutical imaging product operations in Lugano, Switzerland, where he is responsible for quality management review, complaints management, auditing, quality risk management, knowledge management, CAPA management and continual improvement. In more than 25 years’ experience in the pharma/biopharma industry, Michele has held a number of different roles during his career, including: 

    • Microbiology and Environmental Monitoring Supervisor,
    • QA GMP Compliance Site Manager of a sterile fill-finish facility (liquids, lyophilized vials, pre-filled syringes, cartridges),
    • QA/QC Senior Site Manager of a medical device J&J facility (coronary coated stents) with a broad international scope,
    • Global Quality and Training Senior Manager (site and corporate quality) of a Parenteral network of J&J facilities,
    • Head of Quality System and Compliance of two Novartis V&D Vaccines facilities manufacturing APIs and finished dosage forms,
    • Corporate Quality Auditor for API, finished products, and Chemical, Consumer, Commercial Affiliates & Vendors

    Michele is currently on the PDA Italy Chapter Board of Directors as Secretary and is co-chairing PDA’s Interest Group Quality System.

    He has presented regularly at other PDA events, and also served as peer reviewer on PDA’s Journal and PDA’s Letter.

  • Francisco Valero Barranco

    Francisco Valero Barranco, PhD

    Universitat Autònoma de Barcelona

    Dr. Francisco Valero is professor of the Department of Chemical, Biological and Environmental Engineering at the Universitat Autònoma de Barcelona. His research career has focused on Biochemical Engineering, especially in the fields of Bioprocess Engineering, Production of Recombinant Proteins in the cell factory Pichia pastoris, monitoring modelling and control of bioprocesses and Applied Biocatalysis (lipases).

    He has co-lead the Bioprocess Engineering and Applied Biocatalysis Research Group and he has experience as project manager for public and private projects (40).

    Dr. Valero has published over 125 scientific papers in refereed journals, 15 book chapters and has supervised 25 PhD theses.

  • Cathy Vielle

    Cathie Vielle, PhD

    EDQM

    Mrs Cathie Vielle graduated in Pharmacy in 1996 from the University of Strasbourg. Since 1996 she has held several positions in QA compliance and in supply chain departments in an international pharmaceutical company.

    In September 2005, she became Head of Quality Department at a manufacturing site for worldwide markets (e.g. Europe, USA, Japan). She joined the EDQM in May 2009, as Head of the European Pharmacopoeia Department.

  • Anders Vinther, PhD

    Intarcia Therapeutics, Inc.

    Anders Vinther is the Global Head of Technical Operations at Intarcia Therapeutics. Anders previously worked for Sanofi Pasteur, Roche, Genentech, CMC Biologics, and Novo Nordisk in senior leadership roles. Anders is a thought leader on the topics of quality culture, quality leadership, and Post Approval Changes. In PDA he has been active for almost 25 years in various roles including Chairman of the Board of Directors.