United Kingdom

Ros has both a scientific and legal background and has worked in healthcare compliance (HCC) for over 20 years. She leads our HCC and medical approval teams. Ros has worked in several US and Japanese companies and also spent a number of years on the Panel at the Prescription Medicines Code of Practice Authority (PMCPA). Ros has been a consultant for over 10 years and specialises in “crisis management”, supporting clients to navigate activities such as complaints, appeals and PMCPA audits. Ros is the only HCC consultant in the UK to support a company through the complaints process from the Code of Practice Panel level, Appeal Board and up to the ABPI Board, with a successful outcome.

Dora is a Pharmacovigilance Associate Director at PharmaLex with 12 years of industry experience, working for both pharmaceutical companies and service providers. She holds an MSc in Pharmacovigilance and is a committee member for the Pharmaceutical Information and Pharmacovigilance Association (PIPA), where she serves as journal editor and PV compliance lead. Dora is helping lead our UK/Ireland PV team in the implementation of the day-to-day operational PV tasks for clients through our high-level consulting services.

Rob is an Associate Director in our Regulatory Affairs team with over 13 years' industry experience, including a wide array of experience and knowledge in both regulatory project work and technical areas specific to the Pharmaceutical Industry, with a primary focus on global CMC projects.

Andy is a New Zealand trained and UK registered pharmacist and has fulfilled numerous senior management roles in medical affairs, medical information, medical compliance and project / programme management during his 25+ years in the pharmaceutical sector. Andy has split this time working for big global pharma companies and more recently, pharma service providers where he has established and developed global medical information teams and services. Andy is a UK Medical Signatory and manages the UK medical approval team.

David is Head of Pharmacovigilance, Epidemiology and Risk Management with over 35 years of experience in the pharma industry and 25 years working within the pharmacovigilance (PV) sector. David has managed a variety of different PV projects and demonstrates the flexibility required to ensure that our clients can be assured of an efficient and compliant PV system to service their pharmaceutical products. He oversees a team of highly competent PV professionals who can maintain and operate all aspects of an end-to-end PV system and ensure the most appropriate level of support, dependent on each client’s specific needs.

Rob is the Product Manager for the TMF Services Practice Area, with 16 years of experience in the Life Sciences industry he focuses on ways both technology and services can support our customers in reaching and maintaining overall TMF Health. Rob often speaks at industry events and is also a current member of the TMF Reference Model Steering Committee, dedicated to ensuring TMF management is given the attention it deserves and supporting its growth into the future

Graham is a Director, Regulatory Affairs at PharmaLex UK. Graham has over 19 years experience in pharmaceutical regulatory consultancy. Graham leads PharmaLex’s UK and Ireland Regulatory Centre of Excellence service delivery area. He advises a wide range of companies about their regulatory activities in the UK and Ireland.

Martina is a Service Line Lead within Trial Master File (TMF) Services and has almost 20 years’ experience in TMF management, focusing on inspection readiness and good TMF management practices. She advises both Sponsors and CROs on establishing effective inspection readiness strategies for their TMFs, as well as co-ordinating projects of all sizes within TMF Services to support inspection readiness activities, such as TMF Heatmap Analysis and Quality Reviews.