This practical course will take delegates through the essential regulatory requirements for clinical research in Europe and will also include key US requirements which impact on trials in Europe.
The course will also focus on the new Clinical Trial Regulation providing you with practical advice for implementing it. The course will also highlight the major differences between the Regulation and the current Directive. There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
You may choose to take this course either as a 2-day or 3-day course. The optional 3rd day will cover the impact of the GDPR and data protection requirements in Europe on the pharmaceutical industry in the context of clinical trials and pharmacovigilance. Find out more about the course content for the optional 3rd day here.
Laura Brown – Days 1-2
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.
Sumaiya Patel – Day 3
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.
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