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Informa
Starting 23-25 November

LIVE Online Academy - 3 Sessions

Maintain compliance with the Clinical Trials Regulation and ensure the highest ethical standards in your clinical trials

Book with earlybird pricing now!

Receive 20% off if you book before 16 November

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, delivered in bitesize sessions of 1.5-3 hours online.

Over 3 sessions students will learn through:

  • Live interactive bitesize sessions
  • 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.

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