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
Rie Matsui is Director, Regional Labeling Head for Asia, International Labeling Group, Worldwide Safety & Regulatory, Pfizer Japan. She is the founder of Asia Labeling Hub at Pfizer which was established in July 2012. The Asia Labeling Hub has created various local label updates for more than 20 countries in Asia ever since its launch and she works with 14 affiliates in Asia. Apart from her roles in Pfizer, she is a fundamental member of SIAC (now community) for the global labeling working group. She has been a member of the Advisory Council of DIA Japan. She won the DIA Japan regional award in 2015. She has been actively involved in a number of conferences in Japan, China, Singapore and the US, 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
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.
Jun Dong, PhD
- Director, Business Partner for Global Regulatory Affairs and Development, R&D IT
- Sanofi, United States
Barbara Lachmann, MD
- Senior Advisor, Center of Excellence Product Information
- 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.
Shinobu Uzu, MSc
- Chief Safety Officer
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is Chief Safety Officer, PMDA. He is responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law. 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.
- Vice President, Head Labeling
- Bayer, United Kingdom
- Country Manager for West and Central 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.
Michael Fahmy, MS
- Director, Global Labeling Strategy & Regulatory Affairs
- Otsuka Pharmacutical Development & Commercialization, Inc., United States
Herbert L O'Brien
- Sr. Local Labeling Registration Manager
- Bayer HealthCare Pharmaceuticals Inc., United States
- Senior Director, Global Labeling and CCDS
- Astellas Pharma, United States
- 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.
Gina M Monteiro
- Regulatory Quality Consultant
- Eli Lilly and Company, United States
- Senior Director, Head of Global Labeling
- Vertex Pharmaceuticals, United States
- 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 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.