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responsibility and complexity during this time, particularly in the Hematology therapeutic area. Ian has extensive experience in providing strategic support to clinical development teams for a portfolio of products and has led multiple EU regulatory submissions, including new MAAs, line extensions and indication extensions as well as providing regulatory leadership and support for diverse and complex clinical trial programmes. Ian holds a degree in Biochemistry from the University of Bristol. Kora Doorduyn-van der Stoep Kora works at the Medicines Evaluation Board (MEB) in The Netherlands. Her current position at the MEB is EU representative of the MEB. She held several positions within the MEB, both regulatory and management. From May 2009 – November 2020 she was acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures – Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. In October 2020 she has been elected as Chairperson of CMDh starting in November 2020 and in October 2023 she was re-elected as Chairperson of CMDh She is also participating in several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA’s) and variations as an area for special attention. As CMDh chair she is also member of several EMA/HMA Task forces and other groups (like Scientific Coordination Board, EMA/HMA focus groups on resources) She is a member of the HaRP peerreview group which is the group dealing with harmonization of RMPs for the same active substance in the EU. She is coordinator/Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985). Steve Smith With a background in Chemistry, having graduated with a PhD in Organic Chemistry in 2003, Steve then worked as a development chemist for Rhodia Pharma Solutions before starting his regulatory career in 2004 at GSK, working in CMC. After leaving GSK, he worked for Seven Seas, Teva Pharmaceuticals and Mundipharma before returning to GSK and after a spell at Amgen, is currently working for Servier. In his regulatory career to date Steve has worked for small, medium sized and large pharma companies covering both the innovator and generics sector, working with small molecules and biologics across all therapeutic areas. This provides him him a wide and extensive knowledge of the regulatory affairs profession. Jenny Horwood Following the completion of a D.Phil. in neuropsychopharmacology at Sussex, and post doc at the CNRS in Paris in electrophysiology and behavioural models, Jenny worked as a senior scientist for Paradigm Therapeutics for 2 years then went on to join Pfizer in 2006 as a neuroscientist. She then quickly (in 2007) moved into the field of regulatory affairs becoming a regulatory clinical trial strategist. From 2007 to 2022 Jenny continued to grow in her role within Regulatory Affairs at Pfizer both in Europe and the US to become a Senior Director and Global Regulatory Portfolio Lead in the therapeutic area of Rare Disease in 2022. In 2024 (after 18 years) Jenny left Pfizer and founded JMH Regulatory Ltd; a regulatory affairs consultancy business, providing services in the development space to a variety of clients to help them navigate the complex and ever-changing regulatory environment and optimise their development strategies. Additionally, she enjoys teaching, both for clients and at TOPRA, using her experience of interactions with FDA, EMA and national authorities, which has included the compilation / submission / review of varying