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.

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 is an Advisor in Global Regulatory Affairs at Eli Lilly in Indianapolis, Indiana where she currently leads the Regulatory Information and Process Automation group. She received her BS in Pharmacy at Purdue University. 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 served as Process Owner for Global Labeling where she led the improvement of critical processes and the implementation of an end to end labeling tracking system. She is currently leading the implementation of a RIM platform.

Su has held various levels of positions at Intercept, Regeneron, BMS, and former Wyeth with global regulatory labeling and promotion responsibilities in different therapeutic areas for small molecules and biologic products. Su specializes in end to end labeling process with emphasis on Target Labeling planning, Labeling Strategy in Product Development, and Labeling and Promotion Process and Compliance. Su was the Co-Chair of Labeling Working Group for the DIA Regulatory Affairs Community organizing Labeling Conferences and Hot Topics sessions. She is a registered pharmacist and holds a MS degree in Hospital Pharmacy Administration.

Megann Looker (BA Hons) is Head of Global Product 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 the lead for Regulatory Labeling at Celgene for the EMEA region from 2009-2016 and prior to this was in Regulatory Affairs at Wyeth and Apotex. She has served as a KOL member of LabelNet for over 8 years, and as part of the InterAssociation Task Force for IDMP, eLabelling, and DIA SIAC Patient Information.

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has 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 (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

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 S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

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. He also had senior regulatory and clinical positions at 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.

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 focusing on the RA support for Mature products and headed the International RA department before moving to her current position 12 years ago. She is currently VP and Head of Global Labeling at Bayer.

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 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.

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.

Ryan McGowan is the Director of Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of combination products and digital health products including software as a medical device. 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.

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.

Dr. Shinobu Uzu is the Senior Executive Director, PMDA and in charge of the Safety offices, Office of International Programs, and Regulatory Science Center since April 2020. He took Ph.D. in Pharmacy from the graduate school of the University of Tokyo and has over thirty years of experience in MHLW, PMDA. He worked for new drug review as Director of the Office of New Drug I and Associate Executive Director for new drug review, PMDA and safety management for drugs and medical devices as Chief Safety Officer, PMDA and Director of Safety Management, MHLW. He also worked for international affairs as ICH steering committee member on behalf of MHLW and 1st Secretary of the Embassy of Japan in Indonesia.

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.

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.

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 Monteiro has 6 years of labeling management experience with Eli Lilly’s Global Regulatory Labeling organization and currently in the Drug Delivery and Digital Health Global Regulatory Department. She has overseen the development of Core Data Sheets, US and Canadian labeling for Lilly’s Bio-Medicines, Oncology, Diabetes, Medical Device 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.

Dr Shimon Yoshida is Executive Director at Pfizer, and heads the International Labeling Group in Global Regulatory Affairs. Dr Yoshida obtained a PhD in Chemistry from Reading University, UK, and held postdoctoral positions at Durham University before joining the Royal Society of Chemistry in Cambridge. After joining Pfizer in 1999 he worked in a variety of roles across pharmacovigilance, medical writing, safety, and labeling, and is currently leading Pfizer’s global digital innovation project to transform Regulatory Operations processes.

Craig is responsible for leading regulatory informatics projects like the implementation of the Structured Product Labeling (SPL) standard; development of health informatics policy and IT modernization.

Michael is the Global Regulatory Therapeutic Area Lead at Otsuka Pharmaceuticals Development & Commercialization covering multiple Therapeutic Areas including Digital Medicine/Digital Therapy, Cardio/Renal and medical devices. He is accountable for the regulatory strategy in the development of several products in these therapeutic areas and led the first FDA approved digital medicine. Michael has 19 years of experience within the regulatory space covering the U.S., E.U., Japan, and other key geographical areas and has strong expertise with combination products and digital medicine.

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.

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 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.

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.

Beginning her career at Cambridge University, Hayley began working in clinical research. Moving to GSK, continuing a career in clinical trials (HIV, respiratory viruses), Hayley began a part-time PhD and eventually transferred to Regulatory. Hayley joined the ALP team at Biogen Idec (UK) and then moved to the USA to lead Global Labeling. In 2016 Hayley joined Vertex Pharmaceuticals Inc., to lead and develop the Global Labeling function. Subsequently, Hayley joined Scholar Rock as VP of Regulatory Affairs as a therapeutic lead. Then she moved to her current position as VP Head of Regulatory Affairs and Medical Writing at PepGen Inc. a company developing treatments for rare neuromuscular diseases.

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. 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.