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.

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

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.

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.

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.