Global Labeling Conference
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.
Mark A. Collins, PhD, MBA
- Global Labeling Lead, Global Regulatory Affairs
- CSL Behring Biotherapies for Life, United States
Mark A. Collins is Senior Director, Risk Management & Global Labeling Advisor at Endo Pharmaceuticals Inc. in Malvern, PA. Mark has responsibility for multiple REMS programs, including single and shared systems for brand and generic products. Mark’s professional experience includes fifteen years with Wyeth Pharmaceuticals. After starting as a Medicinal Chemist, he spent three years in Project Management and seven years in the Global Labeling Department, and he is now approaching his fifth anniversary as an Endo employee. Mark has participated as a member of the organizing committee for several DIA Labeling and Risk Management conferences, and is a former co-Chair of the DIA Labeling Working Group.
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 Regulatory Affairs
- 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
As the Senior Director and Head of Regulatory Labeling in Regeneron Pharmaceuticals, Inc. NY, Su manages the processes and operations for labeling activities including CCDSs, country labeling for HA submissions, packaging artworks, and target labeling, for development and marketed products. Su previously worked in Global Labeling with BMS, NJ managing global labeling projects and training BMS regulatory personnel in Europe, Asia Pacific, Latin America, and Canada on global labeling process and the CCDS. Su was also an experienced global labeling compliance auditor while working at Wyeth and a clinical hospital pharmacist. Su is the Co-Chair of the DIA Regulatory Affairs Labeling Community.
- Director, EU/RoW Labelling and Advertising/Promotion
- Jazz Pharmaceuticals, 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
Gerrit Nijveldt, MSc
- Senior Director of Labeling
- Sanofi US, United States
Gerrit Nijveldt is the sr Director Global Regulatory Affairs Labeling for the therapeutic area Diabetes and Devices for Sanofi in Bridgewater NJ. He has over 18 years of experience in Global labeling and a broad experience 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 has experience with information management tools, SPL, agency inspections and setting up end-to-end labeling process. He earned his MSc in Medical Biology from the Univ. of Utrecht in the Netherlands and started working in the pharmaceutical industry in 1991, in the Netherlands, in Regulatory Affairs and Medical Information dept.
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Barbara Lachmann, MD
- Senior Advisor, Center of Excellence Product Information
- Barbara Lachmann Labeling Consulting, Germany
Barbara Lachmann is an independent Labeling Consultant located in Hofheim, Germany. She provides consultation for pharmaceutical companies and other organizations on labeling requirements worldwide as well as on adequate labeling processes. She also performs labeling services for creation and maintenance of Company Core Data Sheets (including their implementation) and/or EU labeling documents. Previously, she worked for more than 20 years in the Global Labeling departments of several multinational pharmaceutical companies (Hoechst and its successor companies Hoechst-Marion-Roussel and Aventis, as well as Merck KGaA) and was responsible for global and EU labeling strategies and labeling decision-making.