CRED SMPC 2024

Ronan Donelan Dr Ronan Donelan, HPRA Policy and Stakeholder Lead, has over 25 year’s experience in drug development and regulatory affairs. His career positions have included: EU Head of Regulatory Affairs for a Global CRO, Global Head of Regulatory Affairs for a global mid-size Pharma company, Head of Regulatory Affairs and PV in a start-up Pharma. He has experience in a broad range of therapeutic indication approvals. He has supported several TOPRA workshops during the past 20 years. He holds amMSc in Pharmaceutical Medicine, from Trinity College Dublin and a PhD from Cardiff School of Pharmacy. Khristy Horsley Khristy is an experienced Regulatory Labeling Professional with over 15 years of experience in Regulatory Affairs, Global Labeling Strategy and EU Labeling Operations. Khristy is currently a Associate Director Regulatory Labeling at ICON overseeing a small team of labeling professionals and supporting Labeling Strategy across several pharmaceutical companies. Khristy leads cross-functional teams in the development and lifecycle maintenance of company core datasheet (CCDS), based on signals or new data in alignment with client processes and regulatory guidance. She coordinates and leads cross-functional teams in the review and management of local labeling, content deviations and impact assessments. Khristy has extensive experience updating EU Product information (both Centralized and Mutual Recognition/Decentralized procedures) and supporting Local Affiliates worldwide in the implementation of CCDS updates. Additionally, Khristy has experience in labeling audits, development of end-to-end labeling process, SOPs and continuous improvement activities. Lucy Paterson Lucy is a Regulatory Labeling Professional with 4 years of experience. Lucy is responsible for development and lifecycle maintenance of Company Core Datasheet (CCDS), based on signals or new data in alignment with client processes and regulatory guidance. Lucy also provides support for worldwide labelling submissions to implement CCDS variations and support responses to health authority requests in markets such as the EU, US, Canada, Australia, Switzerland, Japan and China. She coordinates and leads cross-functional teams in the review and management of local labeling deviations. Additionally, Lucy has experience in reviewing and updating EU Product information, supporting the development of client end-to-end labelling processes, including authoring updates to labelling work instructions. She also provides support for client's audits, including researching auditor questions, filling document requests, and presenting on labeling systems.