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Virtual Event

Apr 20, 2020 7:45 AM - Apr 21, 2020 2:45 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Global Labeling Conference

Speakers

Theresa  Brunone, MLS, MS

Theresa Brunone, MLS, MS

Head-Labelling Compliance and Implementation, Global Labeling, GlaxoSmithKline, United States

Terry has been in the pharmaceutical industry since 1993. She has supported Regulatory Affairs and Product Information areas throughout that time. Since 2003, she has worked with US and Global Labelling in Operations and Compliance areas. Her current role of Compliance Director assures that regulatory labelling throughout the local operating companies within GSK are managing their compliance with labelling safety updates. Historical note: She led the Structured Product Labeling Working Group Leadership Team, a group representing manufacturers, vendors, downstream users and the FDA in the varied uses and challenges of SPL, through 2019.

Paula  Hudson, RPh, RAC

Paula Hudson, RPh, RAC

Director, Global Labeling, Eli Lilly and Company, United States

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-Yueh  Lin

Su-Yueh Lin

Sr. Labeling Consultant, Regulatory Affairs, SYL Regulatory Consulting, Taiwan

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.

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling, Pfizer R&D Japan G.K., Japan

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, MSc

Gerrit Nijveldt, MSc

Global Labeling Consultant , Opus Regulatory Inc., United States

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

Hayley  Parker, PhD, MSc

Hayley Parker, PhD, MSc

Vice President Regulatory Affairs, PepGen, United States

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.

Deborah  Bebbington

Deborah Bebbington

Head Global Labeling, Bayer Plc, 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 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.

Bill  Carter, MBA, PMP

Bill Carter, MBA, PMP

Senior Manager, Deloitte , United States

Denise  Globe, MHS, PhD

Denise Globe, MHS, PhD

Executive Director, Gilead Sciences, Inc., United States

Denise Globe has 30 years of experience in health care with a focus on quantitative policy research and direct research experiences in disease management including the outcomes, process, financing and delivery of care. A particular focus has been on assessing the impact of disease and treatment from the patient perspective. She has strategically developed and successfully executed projects spanning a multitude of disease states including rare diseases which have been utilized to inform payer and regulatory decisions. Previous to her industry positions, she was an Associate Professor in the Department of Pharmaceutical Economics and Policy for six years, where her research agenda, focused on outcomes and health policy.

Michael  Roesner, MS

Michael Roesner, MS

Senior Labeling Associate, Eli Lilly and Company, United States

Mike Roesner has 10 years labeling experience with Eli Lilly’s Global Labeling organization. He has led the development of CDS and US labeling for new oncolytic and diabetes products. In addition, he was responsible for maintaining existing labeling and consulting with global affiliates on development and maintenance of local labeling. Recently, Mike has been working with cross functional teams to discuss labeling priorities and strategies for early phase molecules. Prior to joining the labeling organization, Mike held a number of positions at Eli Lilly including toxicology, health & safety, and human resources. Mike obtained his B.S. in Chemistry from Michigan State University and his M.S. in Toxicology from The University of Michigan.

Craig  Anderson

Craig Anderson

Director, International Labeling, Pfizer Inc , Canada

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.

Vishal  Bhatnagar, MD

Vishal Bhatnagar, MD

(Acting) Director for Patient Outcomes, OCE, CDER, FDA, United States

Vishal Bhatnagar, MD, is a medical oncologist/hematologist and Associate Director for Patient Outcomes in the OCE. His interests include patient reported outcomes, patient preference and incorporation of patient experience in oncology trials. His work focuses on the operational management of the OCE’s Patient-Focused Drug Development program. Additionally, Dr. Bhatnagar has a strong clinical interest in multiple myeloma and has previously served as an Office of Hematology and Oncology multiple myeloma scientific liaison. Dr. Bhatnagar received his BA in Political Science and his medical degree at the George Washington University. He completed his internal medicine residency and hematology/oncology fellowship at the University of Maryland.

Maria Sandrino Meinz, MS

Maria Sandrino Meinz, MS

Deputy Director Labeling, Global Labeling , Bayer Healthcare Pharmaceuticals, United States

Mukesh  Singhal, MBA

Mukesh Singhal, MBA

Partner, Deloitte, United States

Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry vision for a next gen regulatory intelligence capability. Mukesh is the product owner of Deloitte’s next gen regulatory intelligence industry solution.

Shinobu  Uzu, PhD

Shinobu Uzu, PhD

Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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.

Karen L. Ciprero, MS

Karen L. Ciprero, MS

Director, Global Labeling, Merck & Company Inc., United States

Karen's career in the pharmaceutical industry, mostly at Merck & Co., Inc., spans 15 years. She has been in Global Labeling for 5 years, creating and updating Core, US, & EU labeling and supporting labeling worldwide for Infectious Disease products. Most recently, Karen has been part of a team that redesigned the labeling process and documentation in Global Labeling. Before Labeling, Karen supported Clinical Research & Operations for vaccines and small molecules, and had a prior career as a pediatric Genetic Counselor. Karen has co-authored publications on genetic/chromosomal syndromes, as well as clinical studies in vaccines. She has a B.S. in Biology from Dickinson College and an M.S. in Genetic Counseling from MCV of VCU.

Nya  Feldthus, MS

Nya Feldthus, MS

Associate Director - Gobal Labeling Implementation , Eli Lilly and Company, Denmark

After completing a PhD in biomedicines at University of Copenhagen, Nya moved into clinical research at Eli Lilly & Co., and then later on she moved into regulatory affairs, specializing in the area of labelling since 2016; she currently works within the Global Labelling Department at Eli Lilly with responsibility for global labelling implementation. Nya has a broad experience in the field of labelling implementation from both a local and global perspective, and through this has developed a deep understanding of current regulatory requirements impacting labelling.

Francis Muigai Karanja, MSc, RPh

Francis Muigai Karanja, MSc, RPh

Regulatory Affairs Cluster Head, Africa, GlaxoSmithKline, Kenya

Francis is a regulatory professional with 20 years’ experience at GSK across Commercial, Regulatory, Medical and Clinical Operations and was actively involved in the pivotal Phase III RTS,S Malaria Vaccine Clinical Trials. Francis is a Registered Pharmacist; holds a Bachelor’s Degree in Pharmacy from the University of Nairobi in Kenya and a Master’s Degree in Pharmaceutical Medicine from Hibernia College in Ireland and is also a Certified Clinical Research Associate (CCRA). He has a keen interest in labelling solutions that work for resource limited settings such as the case in many countries in Africa.

Thomas  Kilker, MS

Thomas Kilker, MS

Director and Interim Head, Regulatory Affairs Labeling , Jazz Pharmaceuticals , United States

Tom Kilker currently serves the interim head of Global Labeling at Jazz Pharmaceuticals in Philadelphia where he’s been since 2016. His previous roles include labeling positions at Janssen, AstraZeneca, Shire and Merck, spanning 19 years across many therapeutic areas for US, EU, and rest of world labeling. Prior to his labeling experience, he was a Quality Assurance auditor for the American Red Cross and a Medical Technologist at the Children's Hospital of Philadelphia in the area of clinical virology..

Martin  McLoughlin, PhD

Martin McLoughlin, PhD

Head of Device Development, Global Product Development and Supply, Bristol-Myers Squibb, United States

Dr McLoughlin has 20 years experience in the development and commercialization of device and combination products across a range of therapeutic areas including inhalation and injection and has led the development of several commercially launched devices and combination products. He has had end-to-end responsibility from concept to launch including the development of advanced manufacturing processes and automation. He is currently Senior Director, Head of Device Development at Bristol-Myers Squibb. He is the first named inventor on more than 25 issued patents in the field of drug delivery.

Aimad  Torqui

Aimad Torqui

Division Head Medicines Evaluation Board, Medicines Evaluation Board, Netherlands

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

Nathalie  Lambot, DrSc, MPharm, RPh

Nathalie Lambot, DrSc, MPharm, RPh

Expert Santé Publique – Clinical Trials & Regulatory Affairs, pharma.be , Belgium

Nathalie Lambot (Expert Public Health – Clinical trials & Regulatory Affairs at pharma.be) Nathalie Lambot has been graduated as pharmacist in from the Free University of Brussels, Belgium, and has had a PhD in Biomedical Sciences from the Free University of Brussels, Belgium. After having worked several years in CRO and pharmaceutical company in international regulatory affairs, Nathalie Lambot has joined in January 2013 pharma.be, the Belgian association of innovative (bio) pharmaceutical industry, as expert in Public Health – Clinical Trials & Regulatory Affairs.

Shannon  Leber, MBA

Shannon Leber, MBA

Associate Director, GRA Quality & Compliance , Janssen Pharmaceuticals, United States

Shannon Leber currently leads Data Analytics & Governance team within Global Regulatory Affairs (GRA) Quality & Compliance. Over her 20+ year career, she has acquired diverse labeling experience, with varied roles across the product lifecycle, supporting both pharmaceutical and over the counter (OTC) product portfolios. Working in Supply Chain roles, her experiences included implementing labeling components on packaging lines, executing new labeling to support product launches and managing new indications/warnings across product lines. In her more recent GRA roles, she has focused on End to End Labeling Process ownership, with an emphasis on measuring cross-functional process performance and compliance, to drive continuous improvements.

Gina  Monteiro

Gina Monteiro

Advisor, Eli Lilly and Company, United States

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.

Chi-Sing  Nip, PharmD, MBA

Chi-Sing Nip, PharmD, MBA

Director, Global Labeling, Hoffmann-La Roche Limited, Canada

Chi-Sing Nip, Pharm.D., is a Director, Global Labeling and Global Team Leader, I2ONE in Product Development Regulatory at Hoffmann-La Roche Limited. Dr. Nip received his Doctor of Pharmacy from Northeastern University, Boston. He has over 17 years of industry experience in both Regulatory Affairs and Drug Safety. Prior to joining Roche, he completed the Rutgers University/Hoffmann-La Roche Pharmaceutical Industry Fellowship Program. Currently, Dr. Nip is a member of the PDR Labeling Leadership Team and is responsible for driving effective strategic leadership, operations oversight, and management of global labeling teams. He also deputizes for the Global Head of Labeling on the Global Label Advisory Group.

Kevin  Stark, MBA, RAC

Kevin Stark, MBA, RAC

Executive Director, Regulatory Affairs, Mallinckrodt, United States

Kevin Stark is Director, Office of Promotion and Advertising Review, Regulatory Affairs at Merck where he leads a team of regulatory reviewers for multiple products within primary care and hospital portfolios. Kevin has over 30 years in the pharmaceutical industry, with positions in a broad range of experiences. Kevin has held positions in the areas of sales, marketing, managed markets, business compliance, operations and regulatory. Kevin has a BA in biochemistry from the University of Wisconsin and a Master’s in Business Administration degree Lehigh University and is RAC certified.

Mark  Hendrickson, MS

Mark Hendrickson, MS

Senior Director, Leavitt Partners, United States

Mark is a Senior Director at Leavitt Partners based in Washington, D.C. He advises health care coalitions and provides policy counsel and analysis involving regulation and legislation. Prior to joining Leavitt Partners, Mark was the Senior Director of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM). He was also an industry negotiator for multiple user fee agreements between FDA and industry and managed several industry working groups focused on pharmaceutical supply chain security and DSCSA implementation. Mark received his B.A. from Miami University and his M.S. in Regulatory Science from the University of Maryland.

Kathleen  Salazar, MA, MBA

Kathleen Salazar, MA, MBA

Head, Global Labeling Implementation, Johnson & Johnson Innovative Medicine, United States

Kathy Salazar is the Head of Global Labeling Implementation at Johnson & Johnson Innovative Medicine. She has over 27 years of labeling experience within J&J, including artwork development, end-to-end tracking, labeling implementation management, and labeling compliance. Kathy has an undergraduate degree from the University of Pittsburgh, graduate degrees from Rutgers and Fairleigh Dickinson University, and is recognized as a Certified Packaging Professional by the Institute of Packaging Professionals.

Meredith  Smith, PhD, MPA, FISPE

Meredith Smith, PhD, MPA, FISPE

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.

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