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.

Hayley received her MSc., and PhD from Imperial College, London. She began her career as a research scientist (studying HCV, HIV, respiratory viruses) at Cambridge University and then GSK, moving to Regulatory in 2004. In 2009, Hayley began working at Biogen in the ALP department in the UK, eventually transferring to the USA to head up Global Labeling. In 2016 Hayley moved to Vertex Pharmaceuticals Inc., in Boston, and as part of the Regulatory Leadership Team built the Global Labeling department, as well as being a Therapeutic Strategy Head. From there she became VP of Regulatory Strategy at Scholar Rock and then PepGen Inc. Hayley is now part of the Executive Team at PepGen Inc., as SVP of Regulatory Affairs and Medical Writing.

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