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.