Maintain compliance with the Clinical Trials Regulation and ensure the highest ethical standards in your clinical trials
Course Overview
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.
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.
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
Regulatory requirements for clinical trials
Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials
Compliance
Compliance
Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance and Clinical Trial Data Management including EDC and e-source
Latest insights
Latest insights
Explore recent developments in clinical trial regulations including FDA requirements
Audit preparation
Audit preparation
Achieve successful regulatory inspections
EU Clinical Trial Regulation
EU Clinical Trial Regulation
Gain an understanding of the new EU Clinical Trial Regulation to prepare for the change
Who is this course for?
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.
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.
