Megann Looker (BA Hons) is Head of Global Product Labelling at Jazz Pharmaceuticals, based in Oxford, UK, overseeing a global remit. Having graduated from the University of Reading in 2001 after studying Classics, English Literature and Sociology, Megann found her way into Regulatory Affairs whilst planning a career in teaching. Over the past 23 years, Megann has held key roles: previously the lead for Regulatory Labeling at Celgene for the EMEA region from 2009-2016, and prior to this, Regulatory Affairs at Wyeth and Apotex. She has served as a KOL member of LabelNet for over 12 years, and was formerly a member of ePI and IDMP Task Forces across Europe.

Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being Expert GVP Inspector. She contributed to the development of the EU GVP Modules, had a role in the training of GVP Inspectors in other EU Member States and contributed 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 QA auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree.