Our blogs and courses made possible by our expert authors. Combined they have decades of experience directing and conducting research across large research institutions. In this blog they distil their experience and understanding, and make it publicly available to readers of the Whitehall blog.
Roger Chapman is a highly regarded expert in the interpretation and application of OECD Good Laboratory Practice (GLP) across a wide range of regulatory studies, both in laboratory and field settings. He possesses significant expertise in Good Clinical Practice (GCLP) within laboratory environments and Good Manufacturing Practice (GMP) in Quality Control labs.
With a long-standing career as a Senior Quality Assurance Manager in the Contract Research industry, Roger has amassed extensive experience in compliance and problem-solving. He has played a pivotal role in over 70 regulatory inspections conducted by the MHRA, FDA, and EPA, and has been instrumental in developing and maintaining GxP quality systems and audit programs for more than three decades.Roger is a frequent speaker at various conferences, both nationally and internationally, and is a seasoned trainer and facilitator for professional development courses focused on Quality, Compliance, and Quality Assurance.
Key Skills:
Steve Jolley is recognized as an expert in global safety compliance and signal detection, often speaking at prominent industry gatherings such as those hosted by DIA and MHRA.
With 25 years of experience in drug safety and pharmacovigilance, he has collaborated with over 50 clients across the United States, Europe, and Japan. He earned degrees in mathematics and computer science from Cambridge University in England. Steve frequently participates as a featured speaker alongside the FDA at DIA conferences and webinars, focusing on topics like auditing, signaling, and data mining.
Steve's career in the pharmaceutical industry began in 1985 when he founded DLB Systems, a company that provided computer systems for clinical trials and adverse event reporting to major life science companies globally. After DLB was acquired by eResearch Technologies in 1997, Steve transitioned to working as an independent consultant.
Dr Laura Brown (PhD, BSc, MBA, and Diploma in Clinical Sciences) is an independent Training and QA Consultant, and Director of the MSc in Clinical Research at the University of Cardiff, and Course Director of the MSc Regulatory Affairs TOPRA.
Dr Brown has extensive experience in the pharmaceutical industry, QA and GCP. She has worked for several companies including Glaxo Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department.
She has been a member of the Research Quality Association since 2000 and also presents training courses for the association such as on ICH GCP E6 R2.
Dr Brown has presented numerous very successful public and in-house courses on GCP for 20 years. She presents public courses for organisations including Management Forum, CTC (Clinical Trial Service Company in Switzerland), Informa, and has presented the overview and advanced GCP parts of the MSc in Clinical Research, Cardiff University for many years. She is also an associate Lecturer at Cardiff University.
She has presented many very successful in-house GCP courses for professionals who work for pharmaceutical companies, study sites and suppliers to pharmaceutical companies to ensure they meet the requirements for running trials to GCP and provide evidence of appropriate training in GCP for regulatory inspection, including the MHRA.
Dr Brown is an international expert on GCP, Clinical Regulations and Clinical Research issues. She was Chairman of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research, the EU Clinical Trial Regulation and GCP. She was a member of the Editorial board of the Good Clinical Practice Journal for more than 10 years. She is the author of several books including SCRIP’s latest GCP guide, and a Practical Guide to the Clinical Trial Directive, written the chapter on GCP in the International Pharmaceutical Product Registration and recent articles on the EU Clinical Trial Regulation and Brexit. Look out for her articles on ICH GCP E6 R2.
Lucy Parker is a research expert, with over a decade of experience directing resaerch across the NHS, Univeritities, and private research institutions. Her specialist knowledge in Good Clinical Practice are how we have been about to disseminate the latest and best practices in the field to our learners, helping them to conduct clinical trials in compliance with the ICH guidelines in 2024.
