Director Global Quality Assurance and Training, TFS-Lund
Alistair has been working with clinical trials since1989 in a number of different roles. Alistair is currentlyworking as Director of Quality Assurance andTraining at TFS Trial Form Support where he has setup and developed the Quality Assurance and Trainingdepartment at TFS. He has held numerous trainingsessions in many different areas including audits,GCP, the European Directive, monitoring etc.
QA Manager and Advisor, TFS-UK
Sheelagh has worked in the pharmaceutical industry for nearly 30 years - in many roles including data management and as a CRA. Her main experience is in training, and she has trained both industry staff and investigators. She has taught widely throughout the EU and Eastern Europe, and also in the USA, Autralia, Brazil, Singapore and Japan.
Fernando García de Blas Crespo
Project Leader, TFS-Madrid
Fernando has been working in Clinical Trials and Non-Interventional studies since 2004, starting in Data Management and after that as CRA and PL in Clinical Operations. His main experience is in Oncology and he has a degree in Chemistry and a Master in Technology and Management of the Chemical and Pharmaceutical Industry.
International Project Leader, TFS-Barcelona
Lecturer, Sanders Communication
Rhiannon Sanders has a broad background in life sciences starting with 10 years in cancer research (PhD), followed by 10 years in the diagnostics industry. She has held positions from project leader to line manager to director of business development. After a further five years working with education issues and entrepreneurship for biotechnology,
Rhiannon started her own company in 2007 to teach advanced presentation technique for leaders, specialists and for challenging situations.
Sr Drug Safety Officer -Team Leader Drug Safety, TFS-Lund
Margareta has a MSc in Pharmacy. She has workedin various positions at AstraZeneca for many yearsand she is well-experienced in pharmacovigilance/adverseevent reporting. She is today responsible forpharmacovigilance, in post-marketing as well as inclinical studies.
Medical Writer, TFS-Stockholm
Catherine Heddle, BSc, PhD, Medical Writer, TFS Trial Form SupportCatherine is a native english speaker and has a PhD in Bioschemistry. Catherine has been working as a Medical Writer for two years. Before that she worked as a research scientist at AstraZeneca’s biotechnology laboratory and at the Department of Oral and Dental Science at the University of Bristol.
Legal expert and economist, Öhman Partners Ekonomi och Juridik
Per is one of Sweden’s “most famous persons” in contracts and agreements in clinical trials. He has been working with internal and external training for staff in the pharmaceutical industry and country councils since the beginning of 1990. He has long experience of commercial and business laws working with different types of agreements in the pharmaceutical
Quality Assurance Manager and Advisor, TFS-UK
Marc gained his PhD, in the hormonal control of seasonal breeding in 1985. The same year he started to work in the pharmaceutical industry. His experience includes 3 years in preclinical development performing drug assays and pharmacokinetic analyses. Since 1990 he has worked in clinical development as a study monitor and then as an international study manager in both France and the UK as a member of multinational teams in several therapeutic areas. He also has experience in continuous process improvement, writing and reviewing SOPs, international clinical operations and currently works as an auditor performing GxP audits. Marc is fluent in French and has a diploma in medical statistics awarded by the University of Paris.
Theo van Delft
Quality Assurance Manager and Advisor, TFS-Netherlands
Theo has been working with clinical trials since 1998, first as a Quality Officer and later in a number of different roles (such as Manager QA, Manager Clinical Research ad interim, Trainer, Project Manager and Consultant).Before that (since 1984) he was working as consultant and trainer, manager, project manager and scientific researcher in different organisations and sectors.
Unit Manager Clinical Operations Northern Europe, TFS-Lund
Helene Rahdevi, RN, Unit Manager Clinical Operations TFS Trial Form Support Helene has been working with clinical trials as a Study Nurse, CRA, Project Leader since 1995. She has worked in Sweden, Denmark and Finland. Since September 2008 Helene is employed by TFS Trial Form Support Sweden as a Unit Manager for Clinical Operations in Sweden.
Medical Writer, TFS-Lund
Ulrika has a PhD in cardiovascular physiology. Before starting out as a Medical Writer two years ago, she was a researcher at the Department of Physiology, University of Gothenburg. She has published 11 scientific articles. Ulrika is a member of the European Medical Writers Association, and currently enrolled in their Professional Development Programme. She is also a lecturer at the medical faculty in Gothenburg.
Senior Medical Writer/Team Leader, TFS-Lund
Hanna Liedman, PhD, Medical Writer, TFS Trial Form Support Hanna has been working as a Medical Writer at TFS for 6 years. Hanna has a PhD in immunology from the University of Lund and has previously worked as a researcher within the fields of immunology and inflammatory diseases, both at the university and in the pharmaceutical industry. She has also been teaching several courses at the university.
Dr, Drug Safety Consult
Dr. Lisbeth Tofte founded the independent consultancy company Drug Safety Consult, providing services within clinical development and pharmacovigilance to biotech and pharmaceutical companies, academia and other institutions working in the health care business.
She originally graduated from the Royal Dental University of Copenhagen to join the pharmaceutical industry shortly after. With more than 25 years experience, she has been responsible for international development programmes in several therapeutic areas, on novel chemical entities, as well as on biosynthetic drugs and human plasma products, working for GSK and NovoNordisk.
As Group Director of International Quality Assurance at Nycomed she held the global responsibility for quality management of development and pharmacovigilance, acting as a driving force behind quality systems and concepts established to facilitate GxP compliance. She is ISO Certified Lead Auditor with broad auditing experience.
She is an experienced speaker and teacher, is author of articles and correspondent on Magazines CQAdvisor, and CRAdvisor. Her book “Computer Validation - A users Guide” is issued by Canary Ltd.
Senior Regulatory Project Manager, NovoNordisk
Vibeke has worked in regulatory affairs since 1980, joining Novo Nordisk A/S in 1988.
She has a master of science in pharmacy and diplomas in biological sciences and business administration.
As a Senior Regulatory Project Manager with Novo Nordisk, Vibeke works with global regulatory affairs, developing new products as well as lifecycle management. Her responsibilities involve the company’s diabetes and growth hormone treatments’ and include project - and life cycle planning to ensure the company’s authorisations on a global basis.