Skip To The Main Content
Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Quality & Regulations Conference 

05 - 06 October 2022

  • 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.

  • Patrick Costello

    Patrick Costello

    AbbVie

    Patrick Costello is the Director of QA at 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 four and a half 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 in charge implementation of European legislation on Blood, Tissues and Cells, Organs and ATMPs.

  • Karin Baer

    Karin Baer

    Neuroderm- a Mitsubishi Tanabe Pharma Group Company

    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, she was VP Quality-Regional Manager and Head of Global Quality Assurance for BI until 2020.

    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 for Neuroderm as VP Quality.

  • Davis-Daniel

    Daniel Davis

    GSK

    Daniel (Dan) Davis currently holds the position of Head of GMP Inspection Readiness & Compliance at GSK Vaccines. In this role, he is responsible for the support of inspection readiness and other GMP compliance activities across the GSK Vaccines manufacturing network. Prior to this, he worked at Lonza Biologics in a number of corporate quality roles, including Head of Sterility Assurance and Microbial Contamination Control. Before joining Lonza, Dan was a GMP Inspector with UK MHRA for around eight years, primarily specializing in the inspection of sterile and biologics manufacturers. He is a Biochemical Engineer by training and received a doctorate in Bacterial Fermentation from the Reading University in UK.

  • Travis Frick

    Travis A. Frick, MSc

    Biologics / Cell & Gene Therapy Manufacturing

    Mr. Frick is a Biologics & Gene Therapy Manufacturing and Quality leader with extensive experience in managing operational readiness and transformational change in business-critical settings. Travis is a hands-on leader who enjoys working in a complex and fast-paced environments. Experience includes execution of strategic priorities, developing talent within the organization, and working in a global, multi-cultural environment. Trevor is an innovative change manager who drives metric-driven quality enhancements, process improvements, and operational efficiencies.

  • Johansen-Jette

    Jette Johansen

    Novo Nordisk

    Jette has 30 years of experience within the pharma industry, mainly within the quality area, with a special interest in the transfer of products from development to commercial phase including process validation and across drugs substance and drug products, small molecules and biotechnology, raw materials, and assembly and packaging processes. Jette has always had a special interest in GMP guidelines. From that perspective, Jette has been working with interpreting new guidelines, and the process of providing comments on behalf of Novo Nordisk and industry organizations. Jette has been a PDA member for many years and has now taken up the challenge of being a member of the 2022 Quality and Regulations Conference committee.

  • AnetteYan Marcussen

    Anette Yan Marcussen, MPharm

    NNE A/S

    Anette Yan Marcussen is an experienced consultant with a demonstrated history of working in the pharmaceutical industry, and profound and proven leadership and management skills from multiple jobs in international companies like Novo Nordisk and Genmab. Anette's expertise areas are Aseptic Pharmaceutical Production, Quality and Regulations, Quality Intelligence, and emerging new regulations.

    Anette's engagement with PDA include Vice Chair in the Regulatory and Quality Advisory Board, member in conference planning committees, Co- Chair in the Pharmacopoeia Interest Group, and member in multiple task forces.

  • Peter Reichert

    Peter Reichert

    Zelect Quality

    Peter Reichert holds a Master of Science in Food Science and Nutrition. He is a Consultant, GMP, QMS, Microbiology and CSV expert, Project Manager and experienced Lead Auditor with 25 years of experience in Research, Management, Microbiology and Hygiene, Device, Biotech, API, Fill and Finish and CMO Quality Enhancement, and Oversight.

    Peter has gathered Management and QP experience in the areas of medical device and biotech, as well as managed the Quality Track document hierarchy and oversight at several larger and smaller projects during his 16-year-long employment at Novo Nordisk. Thereafter, he has worked in the field of vaccines and Quality Excellence within the Hearing Aid Industry, and is now operating as a consultant.

    He has been a PDA representative in the past at the Interested Parties Meeting at EMA and has presented at the first PDA Quality Risk Management seminar and workshop for Industry and Regulatory in Geneva and other events.

  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is the Director at CSL Behring leading the Global Internal Audits & Compliance team. She has 30 years of experience in various roles – quality and operations and R&D - in Biopharma (Lonza, Celgene, CSL). Areas of expertise are Risk Management and Quality Systems, including design and implementation locally and globally, leading Internal Auditing and Hosting Regulatory Inspections, Quality Operations, Biotech R&D, Biopharmaceutical API (DS) Manufacturing, Aseptic Processing, External Vendor Quality Oversight. Eva holds a MSc in Biology from University of Kaiserslautern, Germany. Eva is a volunteer at PDA: member of the RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “QRM for Excipients”, Co-Lead of the Quality Risk Management Interest Group, Co-Lead of the Quality Systems Interest Group, Planning Committee Member for PDA Conferences, Co-Chair of the Remote Audits and Inspections Task Force. Eva received the PDA Distinguished Service Award in 2021.

  • Sean Barry

    Sean Barry

    HPRA

    Seán Barry is a Senior Pharmaceutical Assessor at HPRA, the Irish national agency, where he is head of the biological products assessment team. Seán has extensive experience in the assessment of clinical trials, new product applications, and lifecycle management of biological products, including monoclonal antibodies, recombinant proteins, vaccines, and ATMPs. Seán is the current vice-chair of the EMA Biologics Working Party (BWP), a member of the EMA Biosimilars Working Party, and a member of the Heads of Medicines Agency Biosimilars Working Group. Seán has contributed to the development of several EMA guidelines and is a member of the ICMRA working group developing international collaborative assessment pilots for CMC post-approval changes.

  • Bernasconi-Matteo

    Matteo Bernasconi

    St. Gallen University

    Matteo Bernasconi is a research associate at the University of St.Gallen. At the Institute of Technology Management, he works in the Operational Excellence team with a special focus on the pharmaceutical industry. Currently, his academic work concentrates on preventive risk quality management and data-driven decision-making.

  • Brian Dooley

    Brian Dooley, MSc

    European Medicines Agency (EMA)

    Brian Dooley has worked as a quality specialist in the Specialised Scientific Disciplines Department of EMA since 2016.

    His role involves performing scientific peer review of assessments in new centralised marketing authorisation applications, line extensions, variations, scientific advice procedures, and supporting the development of scientific guidelines by the Committee for Medicinal Products for Human Use (CHMP), its Quality Working Party (QWP), Biological Working Party (BWP), and other working parties and committees of EMA as necessary. He has supported the ICH Q12 drafting process since 2016 and is the EMA member of the Q12 Expert Working Group since mid-2018.

    From 2008 to 2016, Brian worked as a pharmaceutical assessor in the IMB/HPRA (Ireland), where he assessed marketing authorisation, clinical trial and scientific advice applications and managed teams working on post-authorisation variations, renewals, parallel imports and herbal medicines. From February 2015 to January 2016, he was the Irish member of the CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human).

    Brian’s main areas of interest within quality assessment are post-authorisation lifecycle management, assessment-inspection interface, synthetic peptides, oligonucleotides and sterile products. He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) from Trinity College Dublin, Ireland.

  • Drapier-Alexandre

    Alexandre Drapier

    GlaxoSmithKline

    Alexandre Drapier holds a master’s in Chemical and Biotechnologies Engineering and a post-graduate diploma in Applied Molecular Biology. His career in pharma started in an API company with increasing quality responsibilities in all the different quality systems, up to managing the team in charge of final release of API batches. Currently, he is working in the Global Quality team at GSK Vaccines as a Senior Manager lead for inspection management, supporting the vaccines manufacturing network. Additionally, he is the co-author of the PDA PtC in Remote and Hybrid GMP/GDP Inspections.

  • Derek Duncan

    Derek I. Duncan, PhD

    Lighthouse Instruments

    Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He then moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. A member of PDA since 2004, Dr. Duncan has been a regular contributor to PDA conferences and Interest Groups and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

  • Michael Edey

    Michael T. Edey

    Pfizer Inc.

    Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years of experience in Production Management, Quality Assurance, and Technical Leadership. More recently with a global technical role leading CCIT initiatives with an emphasis on quality risk management as part of the application of a holistic science-based approach.

  • Fortner-Zillery

    Zillery A. Fortner

    Sparta Systems

    Zillery A. Fortner is a Product Advisor for QA/RA Life Sciences at Sparta Systems, a Honeywell company. She earned a bachelor’s degree in Health Science from South University. Fortner has over 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, surgery, and JCAHO. In addition, she served ten years in the military as a certified surgical technician. Fortner is an active member of ASQ, AAMI, RAPS, PDA, and AIO AFTO/RAPS Working Group.

  • Thomas Friedli

    Prof. Dr. Thomas Friedli

    University of St. Gallen

    Prof. Dr. Thomas Friedli is a Professor for Production Management at St.Gallen University in Switzerland. His main research interests are in the fields of managing operational excellence, global production management and management of industrial services. He is a lecturer in the (E)MBA programs in St.Gallen, Fribourg, Salzburg, Aachen. He spent several weeks as Adjunct Associate Professor at the Purdue University in West Lafayette, USA. Prof. Friedli leads a team of 15 researchers who develop new management solutions for manufacturing companies in today’s business landscape. In 2007, he became an Associate Member to the International Academy for Quality and joined the Swiss Association for Quality and Management Systems as an advisory council in 2009. Since 2012, he is acting as president of the jury for the REHAU business award. He is also the editor, author or co-author of over a dozen books and various articles. Among his books are: “Quality Control Lab" published in 2020; “21c Quality Management in the Pharmaceutical Industry” published in 2018; “Leading Operational Excellence in the Pharmaceutical Industry” published in 2013; ʺThe Pathway to Operational Excellence in the Pharmaceutical Industryʺ, published in 2010; and “Operational Excellence in the Pharmaceutical Industry”, published in 2006.

  • Grischeau-Michael

    Michael Grischeau

    AbbVie

    Michael Grischeau is the Director of Data Analytics and Management Review at AbbVie. Michael has over 20 years of experience in the Pharmaceutical and Medical Device industry. His professional experience includes ownership of management review processes and global analytics teams that provide strategic insights on quality system health, product data, and site performance across global manufacturing networks. He is currently leading the ongoing redesign of AbbVie's quality management approach to data analytics, incorporating a modernized set of metrics for quality systems and compliance. He is driving automation of processes to ensure they are efficient, easily accessible, and user friendly to enable high impact, cross functional decision making along AbbVie’s product value chain.

  • GhadaHaddad

    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, an MBA and a PhD and has 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.

  • Hawgood-Samantha

    Samantha Hawgood

    GSK

    Samantha Hawgood holds a PhD in Chemistry with a strong academic research background in Pharmaceutical Technology. She has almost 30 years of experience working in the Pharmaceutical/BioPharma and healthcare industry, driving multi-disciplinary, global programs focusing on innovation, analytical, manufacturing process improvements, and operational excellence. Currently, Samantha is the Head of Global Analytical Harmonization and Modernization within the Global Quality organization responsible for driving robustness, harmonization, and modernization strategies across the QC laboratories. In this role she is the sponsor for the implementation of a Continued Method Verification process for analytical monitoring for GSK Vaccines.

  • Hegglin-Michael

    Michael S. Hegglin

    Skycell

    Michael S. Hegglin is heads the Sustainability Department at SkyCell, where he is advancing green pharma logistics. Under his environmental leadership, SkyCell has set Science-based CO2 targets, switched to renewable electricity, received the EcoVadis Gold Medal, and became operationally carbon neutral. Before joining SkyCell, Michael worked as a sustainability consultant and clean energy match-maker in the U.S. (swissnex), Germany (GIZ), and Switzerland (OST). Michael studied environmental sciences at ETH Zurich and Yale University, which provides him with profound knowledge of environmental systems and policies.

  • Alexander Kammerlocher

    Alexander Kammerlocher

    Regierungspraesidium Thuebingen

    GMP/GDP Inspector at the Regierungspraesidium Tuebingen (local competent authority) in Baden-Wuerttemberg, Germany

  • Jesper Kjaer

    Jesper Kjaer

    DKMA

    Director of The Data Analytics Centre at the Danish Medicines Agency, co-chair for HMA / EMA Big Data Steering Group. 20+ years’ experience in data management, analyses and data visualisation having previously worked in academia and pharmaceutical industry. Has headed up activities in EU Framework Programmes, TransCelerate Biopharma. Co-PI of PHAIR: Pharmacovigilance by AI Real-time analyses, applying FHIR resources to health care data in DK for real time safety surveillance. Involved in EHDS pilot work and part of the DARWIN EU advisory board.

  • Thomas Larsson

    Thomas Larsson

    EMA

    Thomas Larsson is a scientific administrator working as Product Lead in the EMA Vaccines and therapies for infectious diseases office, which is responsible for the integrated knowledge-assessment and benefit-risk assessment of medicinal products for infectious diseases, including EU COVID-19 vaccines, throughout their lifecycle: this involves interactions with applicant and EU network prior to submission of applications, management of received applications including preparation of the CHMP Opinion, and post-authorisation lifecycle management

  • Tracy Moore

    Tracy Moore

    TM Pharma Group Ltd

    Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level / status. During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities. Tracy has expertise across most dosage forms and in particular, sterile manufactured products produced aseptically for which she has presented on a range of topics associated with GMP Annex 1 and data integrity. Prior to joining the MHRA Inspectorate, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers.

  • Muench-Stefan

    Stefan Muench

    Koerber Pharma

    Stefan Muench is a Business Director Validation and is responsible for the Validation Services at Körber Pharma Consulting, Karlsruhe. He is a computer scientist with long-standing experience in SW development (MES) and as Principal Consultant for the pharmaceutical industry. Furthermore, for over 10 years Mr. Muench has been a proactive author, speaker, moderator, and trainer for many subjects around SW development, validation, and data integrity. He is an active member of ISPE and the GAMP D-A-CH steering committee.

  • Mulholland-Valerie

    Valerie Mulholland

    GMP Services

    Valerie Mulholland is the Principal Consultant at GMP Services, Ireland. For over 20 years, she has provided Regulatory and Compliance Intelligence, including training and auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries. She is a Lead Auditor across a range of manufacturing technologies, suppliers, distributors, and service providers to EU, FDA, and International requirements. She also provides audit coaching & training. She is a researcher with the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin. The PRST actively engages with global industry and regulators to address the challenges and opportunities of implementing Science and Risk based approaches. The current research focus of the team includes research on quality risk management (QRM), knowledge management (KM), post-approval change management, quality metrics, and related topics covered by ICH Quality Guidelines. Valerie’s area of research is decision making within QRM and the PQS. She is the current Secretary of the PDA Ireland Chapter.

  • Stephan Roenninger

    Stephan Roenninger, PhD

    Amgen (Europe) GmbH

    Stephan Roenninger holds a PhD and engineering degree in Organic Chemistry from the Technical University of Darmstadt, Germany. Stephan was appointed Academic Visiting Expert at the Duke-New University of Singapore (NUS) and Adjunct Assistant Professor at the George Washington University in Washington D.C.

    Stephan focuses in the Quality External Affairs organization at Amgen in Europe, Turkey, Middle East, Africa organizing the operational policy outreach and external ambassador program. He collaborates cross-functionally with internal and external stakeholders, including authorities, associations and competitors on topics regarding quality management, and good manufacturing and distribution practice (GMDP) as well as CMC topics by providing comments on regulatory guidelines, intelligence, and training.

    He also represents Amgen in EFPIA and EFPIA on the ICH training committee and the QIDG. He was a member of ICH Q9-EWG, ICH Q-IWG on Q8/Q9/Q10 and the ICH Q7-IWG. At PDA, he was elected Director of the Board, chaired the Regulatory Affairs, and Quality Advisory Board (RAQAB) and the Inspections Trends Interest Group.

  • Michael Schousboe

    Michael Schousboe, Msc Pharm

    Novo Nordisk A/S

    Michael Schousboe is the Principal Specialist, Quality Risk Management in the Corporate Quality function at Novo Nordisk. He has the overall responsibility for maintaining a well performing and compliant process of Quality Risk Management across the quality management system at Novo Nordisk. Prior to this, Michael successfully managed a wide range of projects providing benefits across the company.

    Michael holds a master’s degree in Pharmaceutical Science (M.Sc. Pharm.) from the Royal Danish School of Pharmacy. He is a Design For Six Sigma Black Belt and has many years of experience within the pharmaceutical industry. With a QC laboratory background and later as a QA professional, Michael has worked with qualification and validation within the areas of computerized systems, laboratories, as well as production of drug products and API in different Danish pharmaceutical companies. He is experienced as a speaker on the aspects of validation and Quality by Design, Quality Risk Management and Quality Systems, and has chaired several conferences. Furthermore, Michael is an experienced auditor and has served as a qualified person.

  • Mai Viholm

    Mai Viholm

    CSL Behring

    Mai Viholm is the Global Head of Quality Systems and Compliance at CSL Behring. She has over 20 years of experience in the pharmaceutical industry and has held various roles in Quality Organization, including R&D Quality, IT Quality, Operations Quality, and Quality Control, with a mix of local and global roles.

    Mai is currently active on various advisory boards related to Quality Management System, Data Integrity, and Digital Quality. Mai has held roles in Denmark, Australia, and most recently, Switzerland, and thus has experience of interacting with various authorities in NDA, pre-approval, and routine health authority inspections.

    Mai also has experience in leading audits, acting as IMP- and DP Qualified Person, and as a Manufacturing Site Quality Lead. In her current role, she is responsible for the Global CSL QMS. Mai graduated as a pharmacist from the Royal Danish School of Pharmacy with a Masters in Analytical Chemistry and Validation.