Global Labeling Conference
Mark A. Collins, PhD, MBA
- Global Labeling Lead
- CSL Behring, United States
Mark A. Collins is the Head of Global Labeling at CSL Behring, a global biotherapeutics leader. He was previously the Senior Director, Risk Management & Global Labeling Advisor at Endo Pharmaceuticals in Malvern, PA. Mark’s professional experience includes project management, Labeling, REMS (Risk Evaluation and Mitigation Strategy) programs, and surveillance and epidemiology programs. Mark received his BSc and PhD degrees in chemistry from the University of Sheffield in the UK and an MBA from Eastern University in St Davids, PA.
A. Leander Fontaine, MD
- Pharmiceutics, LLC., United States
President of Pharmiceutics LLC, a consulting firm based in Pennsylvania, USA. Pharmiceutics offers consulting, training and services for labeling. Before founding Pharmiceutics in 2005, Leander served as Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, for Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst (Germany) and Hoechst Marion Roussel (USA). He has also held positions in clinical development and clinical pharmacology with Behringwerke (Germany). Before joining the pharmaceutical industry, he worked as a physician in internal medicine as well as in anesthesiology, intensive care and emergency medicine.
Paula Hudson, RPh, RAC
- Director, Global Labeling
- Eli Lilly and Company, United States
Paula is the Director of the Global Labeling at Eli Lilly in Indianapolis, Indiana. She received her BS in at Purdue University. She began her career at Lilly in manufacturing technical services, clinical trial packaging and coordination, and quality assurance. Her first role in regulatory was in 2004 as the Director of Site Regulatory Affairs overseeing the CMC Post-Approval organization. Determining Regulatory Affairs would be her home, she took a role in US Advertising and Promotions before arriving in the Global Labeling Department in 2012. Paula also serves as Process Owner for Global Labeling where she has led the improvement of business and governance processes and the implementation of an end to end labeling tracking system.
Su-Yueh Lin, MS, RPh
- Regulatory Labeling Consultant
- Independent Consultant, United States
Currently an independent Sr. Regulatory Labeling Consultant, Su has held various levels of positions at Regeneron, BMS, and former Wyeth with global regulatory labeling responsibilities in different therapeutic areas for small molecules and biologic products. Su specializes in end to end labeling process with emphasis on Target Labeling, Labeling Strategy in Product Development, and Labeling Compliance. Su is the Co-Chair of Labeling Working Group for the DIA Regulatory Affairs Community organizing Labeling Conferences. She is a registered pharmacist in Taiwan and in PA, USA and holds a MS degree in Hospital Pharmacy Administration.
- Director, EU/RoW Labelling and Advertising/Promotion
- United Kingdom
Megann Looker (BA Hons) is Associate Director, Global Labelling at Jazz Pharmaceuticals, based in Oxford, UK since August 2016. She graduated from the University of Reading in 2001 after studying Classics, English Literature and Sociology, and found her way into Regulatory Affairs whilst planning a career in teaching. Megann was previously Associate Director of Regulatory Labeling at Celgene for the EMEA region from 2009-2016 and prior to this was in Regulatory Affairs at Wyeth and Apotex. She is a member of the InterAssociation Task Force for IDMP, eLabelling, and DIA SIAC Patient Information.
Rie Matsui, RPh
- Director, Regional Labeling Head for Asia, International Labeling Group
- Pfizer Japan Inc., Japan
She is currently Director, Regional Labeling Head for Asia, International Labeling Group, Worldwide Safety & Regulatory, Pfizer Japan. She is the founder of Asia Labeling Hub which was established in July 2012. The Asia Labeling Hub has created local label updates for more than 20 countries. She was a Senior Manager for Post-marketing Regulatory Department at Pfizer Japan. Also, she has experiences on labeling, Pharmacovigillance and risk management plans for more than 20 years. She has been a member of the Advisory Council of DIA Japan since 2016. She won the DIA Japan regional award in 2015 andhas been involved in a number of conferences in Japan, China, Singapore and the U.S., both as a session chair and speaker.
Gerrit Nijveldt, MSc
- Senior Director of Labeling
- Sanofi US, United States
Gerrit Nijveldt is senior Director Global Regulatory Affairs Labeling for the therapeutic area Diabetes and Devices for Sanofi in Bridgewater NJ. Gerrit has more than 19 years of experience in Global labeling in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products. Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands
- Hogan Lovells International LLP, Belgium
Elisabethann Wright has been practising in the Life Sciences sector for over 30 years in both private practice and international institutions. She is well recognised for the advice she gives clients in the pharmaceutical, medical devices, and food industries. Her role includes assisting clients in the classification of their products, the establishment of a pathway to authorisation and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations.
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Steven W. Bass, PhD
- Bass Biopharm Consulting Group LLC, United States
Dr. Bass is President of Bass BioPharm Consulting Group LLC and serves as Vice President, Talent Acquisition for Ruderfer and Associates and executive Biopharmaceutical Search Firm. Dr. Bass retired from Bristol-Myers Squibb as Group Director, Global Labeling. Fujisawa and Fujisawa SmithKline Corporation, Wyeth-Ayerst and Eastman Pharmaceuticals. He received his BS in Pharmacy from Philadelphia College of Pharmacy and Science and his PhD in Pharmacology/Toxicology from Thomas Jefferson University, Graduate School of Biomedical Science. He did a postdoctoral fellowship in Cardiovascular/Pulmonary Pharmacology at the University of Pennsylvania.
- Vice President, Head Labeling
- Bayer, United Kingdom
Deborah has been working in the Pharmaceutical Industry for over 25 years. She began her career in Research before moving into Regulatory Affairs. During her tenure at Bayer Deborah worked in the UK affiliate, as an EU liaison, set up a new global RA department focussing on the RA support for Mature products and headed the International RA department before moving to her current position 6 years ago. She is currently VP and Head of Global Labeling at Bayer.
Jun Dong, PhD
- Director, Business Partner for Global Regulatory Affairs and Development
- ITS R&D, Sanofi, United States
Dr. Jun Dong has been working in Sanofi IT department for more than 19 years. He has supported R&D Research, Global Pharmacovigilance & Epidemiology (GPE), and Global Regulatory Affairs (GRA). He has also managed Transverse Technology and Service Solution Center, and implemented enterprise-level technology platforms and services for system integration and business process management. As IT Business Partner he is currently working with GRA leadership teams to define strategic initiatives, align priorities, manage project/program portfolio, and is accountable for IT deliverables and services. His interests are on Artificial Intelligence, Machine Learning, Natural Language Processing, and Digitization.
Barbara Lachmann, MD
- Barbara Lachmann Labeling Consulting, Germany
Barbara Lachmann MD is an independent labeling consultant, providing expert services and training in the field of labeling and regulatory affairs. She started her career in global labeling in 1990 with Hoechst, and has served as Group Head of global labeling functions for Hoechst, Hoechst Marion Roussel and Aventis, and as Head of Global Labeling and Senior Labeling Expert for Merck KGaA. She has also held a position in Pharma Health Politics at Hoechst.
Olga Lucia Anzola
- Head Center of Expertise Labeling LATAM
- Sanofi, Colombia
Labeling Head LATAM at Sanofi, based in Colombia, with 7 years of experience in the regulatory topics, including more than 3 years in labeling at National and multinational companies.
- Associate Director, Combination Products
- AstraZeneca, United States
Ryan McGowan is an Associate Director in Regulatory Affairs at AstraZeneca where he has responsibility for developing regulatory strategies for the approval of combination products and medical devices. Prior to joining AstraZeneca, Ryan was a premarket reviewer and combination products team leader at FDA’s Center for Devices and Radiological Health where he evaluated and influenced regulatory policy for drug delivery constituent parts of combination products.
Herbert L O'Brien
- Sr. Local Labeling Registration Manager
- Bayer HealthCare Pharmaceuticals Inc., United States
Sr. Local Labeling and Registration Manager at Bayer HealthCare Pharmaceuticals. Co-Lead of the SPL Process team, member of the SPL Working Group Leadership Team and SPL Tech Team. Involved in SPL since 2005 and participated various pilot programs including Establishment Registrations, SPL Images, REMS etc.
Shinobu Uzu, MSc
- Associate Executive Director
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is Associate Executive Director, PMDA since April 2018. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu took Master degree of Pharmacy from graduate school of the University of Tokyo. He has over twenty years’ experience in Ministry of Health, Labour and Welfare and dealt with pharmaceutical and food safety affairs including international pharmaceutical affairs and food standard issues.
- Management Associate, Regulatory Excellence & Countries Management, Africa
- Sanofi, France
I have been working within Sanofi for 26 years. My former positions as regulatory country manager on several regions brought me experience and enlarged my vision on regulatory labeling . Since September 2016, I have been in charge of Labeling Excellence activities within Sanofi Africa Middle East Eurasia Region and I have been focusing on labeling performance monitoring and its remediation, on maintaining a constant regulatory intelligence and if needed adapting the Sanofi model to any change in labeling regulations.
- Associate Principal Scientist – Human Factors
- AstraZeneca, United Kingdom
James Meehan, Associate Principal Scientist within the AstraZeneca Device Development, holds a BEng in Medical Mechanical Engineering and an MSc in Ergonomics (Human Factors). James provides specialist Human Factors support to development and on market products. This includes leading and designing human factors programs for products and assisting in managing AstraZeneca’s internal human factors processes.
- Regulatory Labelling Site Head - Welwyn
- Roche Products Limited , United Kingdom
Nisha Modha joined Roche in 2010 and is the Regulatory Labeling Site Head and Global Process Owner of End to End Labeling based in Welwyn, UK. Nisha has BSc (Hons) in Physiology & Pharmacology from The Nottingham Trent University and went onto study for an MSc in Molecular Pharmacology at the University of Manchester. Once graduating Nisha joined GlaxoSmithKline as a research scientist working within the area of neuroscience, in 2005 she moved into the Regulatory Affairs Labelling department before her time at Roche. She is also member of the Inter-association Task Force for electronic product information.
Gina M Monteiro
- Regulatory Quality Consultant
- Eli Lilly and Company, United States
Gina Monteiro has 4 years of labeling management experience with Eli Lilly’s Global Regulatory Labeling organization. In this role, she has overseen the development of Core Data Sheets, US and Canadian labeling for Lilly’s Bio-Medicines, Oncology, Diabetes and Digital Health product portfolios. Prior to joining the global labeling organization, Gina held a number of previous positions at Eli Lilly including US Medical, Pharmacovigilance and US Regulatory, Advertising and Promotion Quality. Gina worked as a Clinical Research Associate (CRA) prior to joining Eli Lilly in 2001. Gina obtained her B.A. from The University of Michigan.
Shimon Yoshida, PhD
- Head, International Labeling Group Worldwide Safety & Regulatory
- Pfizer Ltd , United Kingdom
Shimon has a background in medicinal chemistry research, completing a PhD and postdoctoral assignments in the UK. Shimon joined Pfizer in 1999, working in a variety of roles across pharmacovigilance, medical writing and labeling. He now heads the International Labeling Group, responsible for production and maintenance of local labeling documents across Asia Pacific, Africa-Middle East, Europe (national only), and Latin America. Shimon is also leading Pfizer's global transformation initiative to drive innovation through the Worldwide Regulatory Operations organisation.
- Business Analyst
- Health Canada, Canada
Craig Anderson is a Senior Expert, Program Delivery in the Business Informatics Division at Health Canada. Craig is responsible for leading the implementation of the Structured Product Labeling (SPL) standard; and supporting the implementation of IDMP and eCTD v4. Craig has over 13 years of experience in pharmaceutical regulatory operations and regulatory information management. He has operated as a global line manager with staff in Canada, USA and Sweden; and global responsibility for regulatory submission and information management.
Michael Fahmy, MS
- Director, Global Labeling Strategy & Regulatory Affairs
- Otsuka Pharmacutical Development & Commercialization, Inc., United States
Lynn W. Mehler, JD
- HoganLovells, United States
Lynn Mehler is a partner in the Hogan Lovells' Pharmaceutical and Biotechnology practice, advising clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval processes for new drugs and biologics; on safety issues that include Risk Evaluation and Mitigation Strategies (REMS); and on unique regulatory issues raised during the development and marketing of controlled substances. Lynn spent 12 years with the FDA's Office of the Chief Counsel. She advised the agency on drug safety matters, including at approval and those leading to labeling changes, REMS, and product withdrawal, and she applies that understanding to help clients create effective solutions for FDA regulatory matters.
- Senior Director, Global Labeling and CCDS
- Astellas Pharma, United States
Julie P. Retzinger RN, MBA Julie is the Senior Director of CCDS- Labeling for Astellas Pharma Inc. She provides expertise in the authoring and management of Company Core Data Sheets, early labeling development and life cycle management of labeling. Julie has greater than 20 year experience dedicated to global labeling and CCDS. Julie holds a BS in Biology from Truman State University, her RN degree from St. Francis Hospital School of Nursing, her MBA from Lake Forest Graduate School of Management.
Camiel Hoogendoorn, MSc
- Consultant IDMP
- Iperion / Astellas Pharma, Netherlands
Camiel is one of the consultants at Iperion Life Sciences Consultancy specialized in IDMP and Labeling. He has been involved in multiple projects for both IDMP and Labeling in the Industry and at the regulators. For the past few years he has been a member of the ISO committee involved in the creation of the IDMP standards.
- Consultant, Global Labeling Department
- Eli Lilly Canada Inc., Canada
Luiza Madeira has over 15 years’ experience in Regulatory Affairs. The first 13 years was with the Canadian Regulatory department at Eli Lilly Canada, and she is currently a Labeling Consultant in the Global Labeling Department at Eli Lilly and Company. Luiza participated in Health Canada’s Plain Language Labeling (PLL) industry consultation during the development of the new regulations and was involved in the implementation of PLL at Lilly. In her current role she works on both US and Canadian labeling projects. Luiza has a BSc in Biochemistry from McMaster University and a Certificate of Regulatory Affairs from Seneca College.
- Senior Director, Head of Global Labeling
- Vertex Pharmaceuticals, United States
Hayley received her BSc in Molecular Biology, and her PhD specializing in viral exacerbations of chronic respiratory diseases from Imperial College, London. She began her career at the University of Cambridge, UK, working in clinical research in HCV. From here she transferred to GSK, working on clinical trials for therapies for HIV and respiratory viruses, began a part-time PhD study, and subsequently moved into a Regulatory career in 2004. In 2009 Hayley began working at Biogen Idec in the Advertising, Labeling and Promotions department in the UK, and from there moved to the USA to head up Global Labeling. In 2016 Hayley moved to Vertex Pharmaceuticals Incorporated, based in Boston, MA, and now heads up the Global Labeling department.
- Senior Pharmacovigilance Inspector, Enforcement and Standards
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP) and has had a role in the training of GPvP Inspectors in other EU Member States. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton and a Post-graduate Certificate in Pharmacovigilance.