Our Training Consultants have many years of experience within clinical research, both in their own operational careers and in training others. A key differentiator is that they are also mostly current practicing clinical research professionals so they can bring up to date real life experience into the training room to really bring the material alive. They are a resource able to provide insight to most situations you may be facing in your clinical research role and ensure you get the best from your training experience. All attendees are expected to provide feedback both on the course and the delivery by the Trainer to ensure a continued high level of customer satisfaction.

Abdel is a Reader in Medical Statistics at the School of Life Course & Population Health Sciences. He is an applied mathematician by background, MSc at Paris-Sorbonne University 1999 and PhD at Paris-Orsay University 2002. He has been involved in a variety of clinical research including clinical trials and medical devises with world leading research groups in UK and France, and in both academia and industry. His research interests include clinical trials design and methodology and predictive medicine. Since July 2009, at the School of Population Health & Environmental Sciences he teaches medical statistics and epidemiology for both undergraduate medical students and postgraduate Masters of Public Health. Abdel is postgraduate module lead of both further epidemiology and statistics for Master of Public Health (MPH) and Public Health Interventions and Evaluation (MSc). He is a Fellow of the Royal Statistical Society and active member with quality improvement section. Abdel is a statistical editor and health economic advisor with Thorax

Angela Stokes is a Regulatory Affairs and Quality Management professional with over 30 years of regulatory affairs and quality experience gained in both contract research organisations and pharmaceutical/medical device companies.   She is experienced in medicinal product and medical device development, quality management system setup, maintenance and training, auditing for GxP, clinical trials, registration, post marketing variations, line extensions and life cycle management.

Angela specialises in advising clients regarding regulatory strategy from before non-clinical development through the journey to approval and beyond. She has experience of ICH, FDA and Committee for Medicinal Products for Human Use (CHMP) guidelines for a wide range of pharmaceutical products, and the International Organization for Standardization (ISO) standards for medical devices and quality systems. Angela also provides regulatory affairs training and mentoring as required.

Angela has a scientific background with qualifications in chemistry, mathematics, pharmacology and toxicology, is a fellow of the Royal Society of Chemistry and a fellow of the Organisation for Professionals in Regulatory Affairs (TOPRA) and was the winner of the 2015 TOPRA Award for Contribution, 2020 TOPRA Award for Inspiration and is a former board member of TOPRA, having been President in 2018.

Fiona Wallace, has worked in global CRO and pharma for over 20 years, spanning many countries and Phase I – IV studies such as oncology, ophthalmology, erectile dysfunction and rheumatoid arthritis. She specialises in developing high value retention learning solutions by utilising her breadth of experience in project and CRA management, global clinical regulatory training, inspection readiness management and provision of client solutions to improve staff retention and engagement. Many clinical researchers face the challenge of how to ensure their clinical trials comply with GCP & regulations: Fiona is determined to help them do so with patient safety and data reliability at the forefront.

With over 25 years’ experience in clinical development Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen). In these roles, she has been an accomplished manager and motivator of staff based in China, India, Japan, Europe and US.

Within Wyeth Julianne developed, implemented and ran the key cross functional governance body to drive successful delivery for inspection ready clinical trials. Responsible for the strategic development and implementation of unique, quality and cost-effective methods of outsourcing Clinical Data Management led to the establishment of the ground-breaking Wyeth Accenture strategic alliance in 2003. Julianne had business and operational oversight of the Wyeth/Accenture alliance through the acquisition of Wyeth by Pfizer in 2010. For Wyeth, Biogen Idec and Ipsen Julianne had critical roles in the development and implementation of effective service provider governance.

Joy Dummer is a Clinical Research professional with extensive industry experience gained over 36
years working with several leading CROs in senior management roles as Senior Director of Project
Management. Starting her career as a Project Manager and Global Project Director, she has a proven
track record of delivering key global programmes in all study phases across EU, North America and
Asia Pacific, working with a broad range of Clients from major Pharma to niche start up companies as
well as smaller Biotechs. Responsibilities included providing Senior management governance and
oversight of key Client Portfolios as a member of the Executive Oversight committee. Therapeutic
experience includes Oncology, CNS, Women’s Health, Immunology, Infectious Diseases, Cardio
vascular disease and general medicine, in both adult and paediatric indications.
Joy is also a Registered General Nurse and State Registered midwife. She was an active member of
the ICR Project Management Special Interest Group ( SIG) for over ten years. Joy is an Honorary
Fellow of the Institute of Clinical Research.

Sarah Gill is the head of global monitoring, responsible for oversight of the monitoring department, including developing monitoring strategy, recruitment, line management, team training, project resourcing, and client management at Theradex Oncology.

Prior to Theradex,  Sarah worked in the industry for a number of years in both pharma companies and large, midsize and small CROs focusing ultimately on monitoring and CRA management. She is also a trainer providing monitoring and advanced monitoring courses, for Theradex Oncology and also for the Institute of Clinical Research.

Stuart is a pharmacologist who brings over 20 years of hands-on experience in clinical research and Good Clinical Practice (GCP). His background spans various roles within the pharmaceutical sector, where he has had the opportunity to engage in many aspects of clinical research and regulation.

Notable Experiences

  • NIHR and NHS Scotland: Stuart has had the privilege of contributing to GCP training programs for the UK’s National Institute for Health Research (NIHR) and serving as a GCP trainer for NHS Scotland. These experiences have furthered his understanding of the importance of compliance and quality in clinical research.
  • Quality Management: Stuart has experience managing quality management systems for a variety of clinical studies, from Phase I to Phase IV, as well as non-interventional studies. His work in this area focuses on supporting team members and maintaining study integrity.
  • Regulatory Engagements: Stuart has been involved in coordinating responses to Quality Assurance (QA) audits and Competent Authority Inspections. Additionally, he has participated in the preparation and follow-up for MHRA GCP Inspections, always with the aim of learning and continuous improvement.

Real-World Evidence and Regulatory Guidance

  • Regulatory Advice: Stuart has offered guidance on diverse study types, including non-interventional studies, low interventional clinical trials, and pragmatic clinical trials. His approach aims to facilitate easier navigation through regulatory landscapes for research teams.
  • Gap Analyses: Stuart has contributed to the identification and analysis of GCP and NIS process gaps, with the intention of enhancing research quality and compliance.
  • Educational Support: Stuart has developed and shared GCP training materials to organizations, reflecting his belief in the importance of ongoing education and best practices in the field.

Dr Sally-Ann McDowell has worked in Clinical Research for almost 30 years. She has worked for large and mid size CROs in positions ranging from Data Co-ordinator, Biometrics Project Manager, Clinical Project Manager, Director of Project Management, Therapeutic Area Lead and is currently a Senior Clinical Development Strategy Director. She has global experience in many different therapeutic areas, including CNS, Neurology and Oncology. Sally-Ann has been a member of ICR for many years and was involved in the Project Management Special Interest Group and helped organise the ICR PM Forum in 2022. She is currently a Board member of ICR as well as being a STEM Ambassador.

Dr Tina Barton is an experienced drug development specialist with a broad knowledge within health care. She has held Senior Management operational roles in large global through mid-size to small emerging drug development organisations, providing leadership in trial delivery, managing teams and training for the future.  As a past Chair of The ICR and Board Member (2000 – 2007) Tina’s commitment to The ICR led to her re-joining the Board in 2021. With her continued passion for sharing knowledge, raising standards and developing professionals, she develops and leads The ICR training initiatives.

Russell Joyce is an Information Governance Consultant with over 25 years’ experience in life sciences, legal sectors, NHS, banking, professional services, and in the serious fraud office.

Russell is the HSRAA Director, and co-author of numerous HSRAA publications including; eTMF Evaluation and Selection, TMF Relevant Communications Guidance, Guidance on the Scanning and Destructions of Original TMF Documents, Impact of EU536/2014 on Clinical Records Management, Evaluation and Selection of Commercial Archive Contractors, and the Guide to the Use of Digital Signatures.

An active DIA Member, Russell is Co-Chair of the DIA Document and Records Management Group, DIA TMF Ref Model Steering Committee Member, and Project Lead for Non- Interventional Studies, TMF RM.

In his free time Russell is a passionate tuba player.