CRED Understanding Clinical Development 2024

He is the author of over 140 articles on modelling and simulation, molecular and clinical pharmacology, and risk assessment. Carly Barraclough Carly Barraclough completed a BSc in Pharmacology at the University of Southampton. She began her career in Regulatory Affairs in 2013 with Chiltern before joining Quintiles where she managed Regulatory and Ethics Committee submissions for the Phase 1 unit. In 2016 Carly joined Gilead, where she worked in the UK and Ireland Affiliate. In this role she was responsible for the preparation of routine regulatory submissions for Clinical Trials and national marketing authorisations. Additionally, she reviewed promotional material in line with the ABPI code of practice. Whilst at Gilead, Carly completed a MSc in Clinical Pharmacology at Kings College London. In 2020, Carly joined Amgen where she has worked as a European Regulatory Lead within the Oncology department. This role requires the formulation and execution of European regulatory strategies which encompasses clinical drug development planning, submission of scientific advice requests, orphan drug designations and paediatric investigational plans and a variety of post authorisation procedures. Janet Jepras Jan Jepras is a pharmacovigilance consultant with over 30 years’ experience of drug safety across all phases of drug development. Jan is a scientist by training; she holds a biology degree and a postgraduate diploma in pharmacovigilance. Jan has worked for several large pharmaceutical companies across her career including MSD, Smith Kline Beecham and GSK. She has worked across all areas of pharmacovigilance from case processing through to signal evaluation and risk management type activities. She has worked across multiple therapy areas and has worked on products both in clinical trials and post marketing. Jan went freelance in 2010 and now operates as a freelance PV consultant and has worked with many clients both big and small over this time. Jan specialises in pharmacovigilance writing, authoring regulatory licensing submissions and risk management plans but also writes other regulatory responses and periodic reports. Jan also acts as the UK qualified person for pharmacovigilance and national contact person for pharmacovigilance for clients and is also involved in training on pharmacovigilance processes and initiatives. Jana Žižkovská Jana Žižkovská is a Doctor of Pharmacy from the Czech Republic. After graduation, Jana worked as a pharmacist in a public pharmacy. After passing the attestation exam, Jana started working at the State Institute for Drug Control, first as an assessor of drug substitutability, now for last 7 years as a clinical assesor in regulatory department. The main focus of her job is to assess clinical documentation for national and decentralized procedures – the new marketing authorisation or their subsequent variations. Jana specializes in the field of antiinfectives, antibiotics above all. Jana is a member of state advisory group for antiinfectives, which brings together representatives of professional societies and experts in the state administration. Last, but not least, Jana works as a safety assessor in centralized procedures.