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Omni Shoreham Hotel

Sep 12, 2016 7:00 AM - Sep 13, 2016 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Global Labeling 2016

Essential Updates on Worldwide Regulations and Guidelines


Dora W Cohen, MSc

Dora W Cohen, MSc

Director, Global Labeling, PRA HS, United States

Dora Cohen leads the Regulatory Global Labeling group at Amgen. She has held this position for the last 10 years managing end-to-end labeling documents from Core Data Sheets, Regional Prescribing Information, Instructions for Use, and Package Component Labeling. Dora brings nearly 35 years of pharmaceutical experience and has performed roles in Clinical Trial Management, Regulatory Writing, and Labeling. Dora holds Bachelors of Arts and Master of Science degrees from University of Bridgeport.

Mark  Collins, PhD, MBA

Mark Collins, PhD, MBA

Principal Consultant, Opus Regulatory, 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

A. Leander Fontaine, MD

President, 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

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

Sudip  Parikh, PhD

Sudip Parikh, PhD

Senior Vice President and Managing Director, DIA Americas, DIA, United States

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

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.

Megann  Looker

Megann Looker

Executive Director, Head of Global Labeling, Jazz Pharmaceuticals, United Kingdom

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.

Anthony  Bantug, MS

Anthony Bantug, MS

Principal Engineer, Packaging Engineering and Labeling, Amgen, United States

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.

Valerie  Fenster

Valerie Fenster

Senior Manager, Human Factors Engineering, Device Technologies, Amgen Inc., United States

Barbara  Lachmann, MD

Barbara Lachmann, MD

Sole Proprietor, 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.

Victoria  O'Keefe

Victoria O'Keefe

Benefit Risk Scientific Assessor, Medicines and Healthcare Products Regulatory Agency, United Kingdom

Joseph P. Thomas, JD, PharmD, RPh

Joseph P. Thomas, JD, PharmD, RPh

Chair of Life Sciences Group and Co-Chair, Litigation, Ulmer & Berne LLP, United States

Morgan  Walker, PharmD, MBA

Morgan Walker, PharmD, MBA

Patient Labeling Reviewer, FDA, United States

LT Morgan Walker is a Patient Labeling Reviewer for the Division of Medical Policy Programs (DMPP), Office of Medical Policy Initiatives/OMP/CDER/FDA. Currently, LT Walker evaluates patient labeling for several divisions within the Office of New Drugs for compliance with regulations and patient labeling standards. Prior to DMPP, LT Walker served as a Safety Evaluator within the Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology. LT Walker received her PharmD from Howard University, completed a 2 year Health-Systems Pharmacy Administration Residency at Johns Hopkins Hospital and received her MBA at Johns Hopkins University.

Jibril  Abdus-Samad, PharmD

Jibril Abdus-Samad, PharmD

LCDR, Labeling Reviewer, Office of Biotechnology Products, OPQ, CDER, FDA, United States

LCDR Jibril Abdus-Samad is the Labeling Reviewer for the Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality/CDER/FDA. Currently, LCDR Abdus-Samad evaluates labeling for all biological products within OBP for compliance with regulations and labeling standards. Prior to OBP, LCDR Abdus-Samad served as a Safety Evaluator within the Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology for 6+ years. He practiced in various pharmacy settings within the Veterans Affairs System and private sector. LCDR Abdus-Samad received his PharmD from the University of the Sciences in Philadelphia and a Graduate Certificate in Patient and Product Safety from the University of Southern California.

David H. Dorsey, JD, MA

David H. Dorsey, JD, MA

Senior Director, Americas Head, Global Regulatory Policy and Intelligence, Janssen Research & Development, LLC, United States

David Dorsey leads a group at Janssen R&D focused on pharmaceutical regulatory policy at the US FDA and in Latin America. Before joining Janssen, David served at the FDA in various roles, including Acting Assistant Commissioner for Policy and Planning, Acting Deputy Commissioner for Policy, Planning, and Budget, and Assistant Chief Counsel. For over 8 years, David was detailed from the FDA to the Senate Health, Education, Labor, and Pensions Committee, where he worked for Senator Edward M. Kennedy on FDA and public health matters, including the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Food and Drug Administration Act of 2007, and the Biologics Price Competition and Innovation Act of 2007.

Tamara  Johnson, MD, MS

Tamara Johnson, MD, MS

Acting Team Leader, Division of Pediatrics and Maternal Health, OND, CDER , FDA, United States

Dr. Tamara Johnson is Acting Team Leader for the Maternal Health Team in the FDA/CDER/ Office of New Drugs/Division of Pediatric and Maternal Health. The Maternal Health Team is responsible for evaluating the safe use of drug and biologics products in pregnant and lactating women. Dr. Johnson earned her Doctorate in Medicine from the Rutgers Robert Wood Johnson Medical School and completed residency training in General Preventive Medicine/Public Health.

Michelle  Remillard

Michelle Remillard

Senior Policy Analyst, Pharmaceutical Drugs Directorate, Health Canada, Canada

Michelle Remillard is a Senior Policy Analyst with Health Canada’s Health Products and Food Branch and holds an Bachelor of Science degree from the University of Guelph. With over 25 years experience between the Pharmaceutical Drugs Directorate and the Biologic and Radiopharmaceutical Drugs Directorate, she has led a variety of drug policy and regulatory initiatives. Michelle is currently leading the Transparency project under Clinical Trials Modernization.

Julie P.  Retzinger, MBA, RN

Julie P. Retzinger, MBA, RN

Senior Director - Global Labeling and CCDS, Astellas Pharma Inc., 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.

Elisabeth  Walther, JD, PharmD

Elisabeth Walther, JD, PharmD

Regulatory Counsel, FDA, United States

Elisabeth Walther is a health scientist policy analyst at the US Food and Drug Administration where she currently leads regulatory policy development related to patient prescription drug product information. She also continues to practice as a community pharmacist. She holds a Doctor of Pharmacy and Juris Doctor from Drake University.

Tara D Baer

Tara D Baer

Executive Director, Global Labeling, PRA Health Science, United States

An experienced leader in Medical Device and Pharmaceutical labeling, Tara has worked at such industry leaders as AbbVie, Boston Scientific, Wyeth and Intervet, where she developed a passion for End-to-End Labeling Management, from safety through distribution. An experienced manager, guide and motivator she has led diverse teams of professionals towards collaborative solutions. She specializes in translation management, workflow, content development, artwork management, automated tracking/process integration, and asset management. Tara is the founder of Leaders in Labeling, a group of thought leaders in labeling for regulated products, pharmaceutical, biologics and medical devices.

Bruce  Leicher, JD

Bruce Leicher, JD

Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc., United States

Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals, Inc. Mr. Leicher has advised biotechnology companies for over 25 years. Mr. Leicher is a frequent lecturer on biotechnology law and is Chair of the Board of the Biosimilars Council, a Division of the Association for Accessible Medicines (AAM). In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale & Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the US District Court in DC after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.

Ann  Robards, MS

Ann Robards, MS

Labeling Consultant, Eli Lilly and Company, United States

As the global regulatory affairs labeling consultant, Ann is responsible for creating global and affiliate medical device labeling, including labeling for Mobile Medical Applications. She partners with a cross-functional group of device and software engineers to collaboratively develop content for the user interface of Lilly’s digital device initiatives to align with US FDA regulations and patient labeling guidelines. She has worked for Lilly over 11 years with prior experience in pharmaceutical sales and clinical research. Ann holds a BS in Animal Science and a MS in Animal Nutrition. Ann recently completed a Certification in Health Literacy and Communication for Health Professionals with the University of Nebraska Medical Center.

Vijay  Sammeta, DrMed, MBA

Vijay Sammeta, DrMed, MBA

Senior Director, GRA Labeling, Sanofi, United States

Vijay leads a team of global labeling strategists focused on development and marketed products across multiple therapeutic areas at Sanofi. He has worked on labeling for several new products registered in US, EU and globally. Prior to his current role, Vijay worked in areas of medical communications, evidence based medicine and drug safety & epidemiology.

Lonnie D. Smith

Lonnie D. Smith

Policy Analyst, Office of the Chief Scientist, Office of Health Informatics, OC, FDA, United States

Lonnie Smith has been a member of the Food and Drug Administration's Data Standards Council's Structured Product Labeling Data Standards Team since 2004

Veronica  Yip

Veronica Yip

Acting Manager, Labelling Division, Health Canada (TPD), Canada

Veronica Yip has over 13 years of Canadian pharmaceutical regulatory experience. As the Manager of the Labelling Division in the Therapeutic Products Directorate (TPD), she is currently responsible for advancing TPD's current and future drug label review mandate and delivery objectives. Ms. Yip previously worked as a Labelling Reviewer for three years with the Bureau of Pharmaceutical Sciences. She has also served as Acting Manager of the Regulatory Project Management Division in TPD; and Senior Regulatory Manager for various review bureau. She holds a Honours Bachelor of Science in Human Biology from the University of Toronto and a Post-Diploma in Regulatory Affairs and Quality Operations.

Michelle L. Halliez

Michelle L. Halliez

Associate Vice President of Global Labeling, SANOFI, United States

Michelle has over 18 years of experience in the pharmaceutical industry and has broad experience spanning a variety of roles in labeling, promotion compliance, regulatory operations, and medical information across several therapeutic areas. Michelle has made direct contributions to over 20 new product launches. She has acted as a change catalyst throughout her career with extensive understanding of change management, process development and optimization, organizational transformation, establishing end-to-end corporate policy, and implementing information management tools.

Takashi  Misu, PhD

Takashi Misu, PhD

Principal Coordinator, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Takashi Misu is a Principal Coordinator in the Division of Regulatory Cooperation for the Office of International Programs at the Pharmaceuticals and Medical Devices Agency (PMDA). He previously worked at PMDA as a reviewer in the Office of New Drug II from 2019 to 2022 and as a safety evaluator in the Office of Pharmacovigilance I from 2010 to 2019. He was dispatched to the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research for FDA, United States as an ORISE Fellow from October 2016 to October 2017.

Tracy  Rockney, JD

Tracy Rockney, JD

Co-Founder and Managing Partner, Onesource Regulatory, United States

Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory, a consulting firm specializing in Regulatory Advertising & Promotion, Medical Review, Labeling Development and Healthcare Compliance. Tracy received her JD from Washburn University School of Law, and her BA from the University at Albany, SUNY, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases.

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