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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Europe Quality and Regulations

9-10 June 2020, Dublin, Ireland

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • David Churchward

    David M. Churchward, MSc

    MHRA, UK

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

    He has extensive involvement in international regulatory harmonisation and collaboration through the PIC/S sub-committees for Strategic Development (deputy chair) and GMP Harmonisation. He is also PIC/S delegate to the ICH Assembly and MHRA’s representative at the EMA GMP/GDP Inspectors Working Group.

    David is co-chair of the PIC/S data integrity working group. He led the MHRA’s GxP data integrity expert group from 2013 to 2017, was rapporteur for the 2016 EMA data integrity guidance, and part of the drafting team for the 2016 WHO guidance on good data and record management.

  • Brendan Cuddy

    Brendan Cuddy, MSc

    European Medicines Agency (EMA)

    Brendan Cuddy joined the European Medicines Agency as a Scientific Administrator in October 2002.

    Brendan is currently Head of Manufacturing Quality and Supply Chain Integrity Service and since May 2017, he is Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG).

    The Manufacturing Quality and Supply Chain Integrity Service 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 issues Certificates of Pharmaceutical Product and issues Notices for Parallel Distribution of for Centrally Authorised Products.

    The Service provides the Chair and secretariat of the GMDP Inspectors Working Group and the secretariat for the Quality Working Party.

    The Service plays a key role in collaborating and communicating with international partners on GMP standards and co-ordinates technical input into Mutual Recognition Agreements with third countries.

    Brendan obtained his degree in Chemistry from University of Dublin, Trinity College in Ireland. He holds a Master’s degree from the National University of Ireland in Quality and Operations Management and a postgraduate diploma in Pharmaceutical Manufacturing Technology from University of Dublin, Trinity College which satisfies the educational requirements for Qualified Person.

  • 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.

    In January, she became the PIC/S Deputy Chair and will be 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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
  • 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.

  • Lothar Hartmann

    Lothar Hartmann, PhD

    Phact GmbH

    Lothar Hartmann obtained his Diploma in Technical Chemistry and his Ph.D. in Biotechnology from the Technical University of Berlin. He joined Hoffmann-La Roche in 1988 and served in numerous functions in the global Quality Department. Lothar acted as Head of "Pharmaceutical Quality Systems & External Relations" and “Knowledge Management”. In 2011 he became Head of Quality at a large Johnson & Johnson site before becoming independent with ‘PhACT’.

    Lothar Hartmann served in numerous organizations such as APIC/CEFIC (Vice-Chairman), EBEs (European Biopharmaceutical Enterprises) BioManufacturing Working Group (Founder & Chair of the group), PDA (“Board of Directors”, Quality Systems Interest Group Chair) and ISPE (Special Interest Group ‘Pharma 4.0’).

  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is a Quality Professional with 25+ years of experience in various functions –operations and quality- within multi-national biopharmaceutical and biotech industries:

    Risk Management, Quality Management System, Internal and External Auditing, Change Management, Regulatory Inspections, Global Systems’ Implementations, Quality Operations (Investigations, Change Management, Training, Environmental and Clean Utilities Monitoring, Equipment Cleaning/Cleaning Validation, Compliance), Biotechnology R&D, process transfer and production experience covering fermentation, bio oxidation, strain selection and including project management in aseptic production of biotech cGMP APIs.

    Currently, Eva is active in Global Quality Risk Management at CSL Behring.

    She has been a long-term volunteer for PDA in various functions such as board member of RAQAB (Regulatory and Advisory Board), chair of the working group for the IPEC/PDA Technical Report “Formalized Risk Assessment for Excipients”, Coordinator for the PDA Interest Group Quality Risk Management, member of Steering "Creative" Committee of PDA Quality System Interest Group, and Planning Committee Member for PDA Conferences.