Clinical trials are pivotal to the development of new therapeutic products, generating the safety and efficacy data required to gain regulatory approval. They also generate the evidence required to gain reimbursement and market access. Clinical trials are essential but they are also risky - to ensure patient safety they must comply with strict regulations and approval processes. The Clinical Trial Regulation in Europe has created a simpler system to navigate multi-Member state trials in terms of approval and reporting.
Over 2 days you will examine the history of clinical trial requirements, the new Clinical Trial Regulation and best practices for ensuring a timely clinical trial authorisation. Through case studies and discussion you will explore important frameworks in clinical trial regulations, including: ICH GCP, Ethics Committee Application, Clinical Trials in Children and Adverse Events reporting.
Dr Laura Brown is an independent training consultant. She also acts as Director of the MSc in Regulatory Affairs, TOPRA and Course Director of the MSc in Clinical Research, Cardiff University. Dr Brown is an international expert on regulatory requirements in clinical research. She was Chairman of the Institute of Clinical Research GCP Forum for six years, and writes regularly on clinical research regulatory requirements, having authored SCRIP’s latest GCP guide, and a practical guide to the Clinical Trial Directive. She is a member of the editorial board of the Good Clinical Practice Journal.
The course is relevant for anyone involved with clinical trials or liaising/supporting Clinical research professionals in pharmaceutical, biotechnology CRO and SMO – companies, or study sites including investigator initiated studies. It is also relevant to professionals who liaise with clinical trial personnel (regulatory affairs, clinical trial supply, quality assurance, document management, legal) and all other professionals who want to know more about regulations covering clinical trials.
"I felt the course was very complete. The interaction with the trainer was great and it was good to have an overview on regulatory affairs for clinical trials."
Regulatory Affairs Specialist, A.C.R.A.F. S.p.A.
"The CTA overview and resources provided were very good. The majority of the content was relevant to the intersection of CT's and Regulations, which is what my work focus is."
Clinical Trial Commercial Product Regulatory, Eli Lilly and Company
"The case studies and interactive nature of the course was the aspects I enjoyed the most. I also liked the introduction session."
Regulatory Consultant Clinical Trial Materials, Eli Lilly and Company
"The trainer had a good amount of knowledge and I found the slides used were great. Overall, the course met my needs."
Regulatory Affairs Manager, IDIS/Clinigen group
“I found the course very informative and interactive. It was a great overview of regulatory affairs.”
Senior Advisor, JAZMP
“I took this course to gain a holistic overview of requirements for conducting clinical trials in the EU. I enjoyed the description of the new process for submission/evaluation of CTAs in the new regulation. “
Regulatory Affairs CMC Professional, Novo Nordisk