Maintain compliance with the Clinical Trials Regulation and ensure the highest ethical standards in your clinical trials
Course Overview
This practical course will take delegates through the essential regulatory requirements for clinical research in Europe and will compare with key US requirements. The course will also focus on the new Clinical Trial Regulation providing you with practical advice for implementing it. The course will highlight the major differences between the Regulation and the Directive. There will also be additional time for delegates to discuss the implications of Brexit on this subject matter.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Over this live online course students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Regulatory requirements for clinical trials
Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
Compliance
Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance and Clinical Trial Data Management including EDC and e-source
Latest insights
Explore recent developments in clinical trial regulations including FDA requirements
Audit preparation
Achieve successful regulatory inspections
EU Clinical Trial Regulation
Gain an understanding of the new EU Clinical Trial Regulation to prepare for the change
Who is this course for?
This course is relevant for anyone involved in clinical trials in Europe, or liaising/supporting research professionals in pharmaceutical, biotechnology CRO/SMO companies.
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
Delegates of our live online academies said...
94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others