CRED SMPC 2024

Thomas Liebers Regulatory leader with over 15 years of expertise in the healthcare sector and pharmaceutical industry. My diverse background encompasses clinical nursing practice, experience at the European Medicines Agency, and successful leadership of an international team delivering regulatory services to the pharmaceutical and biotech industries. Central to my approach is a commitment to cultivating thriving client partnerships that offer flexible and cost-effective solutions. Adapting to evolving client requirements, I demonstrate strong management and oversight skills, ensuring the consistent delivery of top-tier regulatory services. These efforts have directly contributed to several successful initial authorizations of groundbreaking and innovative treatments. Overall, my track record reflects a steadfast dedication to excellence, innovation, and driving positive outcomes in the dynamic field of healthcare regulations. Julia Coombes I completed my BSc in Physiology and PhD at the University of Edinburgh. Following this, I took up two post-doctoral research positions at the National Institute for Medical Research (NIMR) and St Mary’s Hospital, Paddington. In July 1995 I joined the MHRA (MCA at the time) as a scientific assessor with the Product Information Quality Unit. I am now the Unit Manager, managing a team of three assessors. The team is responsible for the assessment of labels and leaflets for licensed medicines, in line with current legislative requirements. My work also involves investigation of complaints regarding medicines packaging, parliamentary work such as private office and treat official cases and projects to improve the quality of patient information. Robert Hetherington Rob has over ten years of regulatory labelling experience. For over six years, Rob has managed CCDSs for a number of innovator products across a range of therapeutic areas, coordinating and leading cross functional teams to ensure safety and efficacy concepts were introduced effectively into worldwide labelling. Rob has contributed to the creation of local Product Information for worldwide territories such as Brazil, China, Russia (EAEU) and Japan, ensuring compliance with CCDSs, accurately recording deviations and requesting approval from Labelling Oversight Committees when required. Rob has been involved in the development of labelling processes and actively contributed to the successful integration of processes. Rob also has experience within a generic pharmaceutical setting where he supported the creation and maintenance of product information for EEA (EU) Marketing Authorisations during applications and throughout the product lifecycle.