Short Course
Monitoring Safety in Clinical Trials and Drug Development (Online)
Venue
Online
Date
24 February 2027 - 25 February 2027
Course overview
This course focuses on global clinical trial regulations and implementation with a focus on EU, ICH and US. The global regulatory framework continues to evolve with the 2025 full implementation of the Clinical Trials Regulation and the updated UK clinical trial requirements which will be implemented in 2026. This course also considers the regulations for clinical trial safety reporting in a global PV system under divergent regulations. This course is aimed at providing delegates with an overview of the current regulations pertaining to safety within Clinical Trials, practical applications from a safety perspective, as well as highlight some of the challenges companies faced in the implementation of safety standards and best practice in order to comply with applicable legislation.
Please note, the course dates and programme may be subject to change.
Who should attend
This course is aimed at:
- Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
- Staff from regulatory authorities
How our course works
- Taught over two days online
- A combination of lectures and interactive workshops
- Interact with other delegates and speakers via scheduled discussion sessions
- Full access to PDFs and recordings of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Delegates will be sent a Teams link in advance to enable you to join the live course at the stated time
- Certificate of attendance provided upon completion of the course
Our fees
Registration fees include electronic access to all course materials.
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
Academic
£775 + VAT
(Academic Units, Public Sector Organisations, Registered Charities)
Standard
£1190 + VAT
Aims of the course
- To provide delegates with the theoretical and practical understanding of the issues involved in pharmacovigilance planning and monitoring throughout drug development programmes
- To analyse the principles of risk management and illustrate their application to pharmacovigilance, including the role and application of Data Safety Monitoring Boards and implementation of the Investigator Brochure Reference Safety Information as well as the Development Safety Update Report (DSUR)
- To review critically pharmacovigilance regulatory requirements plus corresponding roles and responsibilities of the pharmaceutical industry in safety data management for optimal protection of patients in clinical trials
Learning outcomes
On successful completion of this course delegates should be able to:
- Demonstrate an informed critical awareness of EU and US regulatory safety requirements as they pertain to clinical studies
- Understand the role and situations where a study may deploy the use of Data Safety Monitoring Boards
- Identify and locate the key sources of information and documentation relevant to developmental risk management activities
- Understand the challenges in implementing the Investigator Brochure Reference Safety Information
- Critically explain the strengths and weaknesses of pharmacovigilance planning systems
Programmed features
- EU and US Clinical Trial Regulations
- Pharmacovigilance planning and monitoring in drug development, including communication to trial subjects
- Implementing the Investigator Brochure Reference Safety Information
- Development of labelling – the developmental safety information through the core data sheet and SPC
- Risk management in drug development – planning and risk minimisation
- Monitoring safety in clinical trials
- Data Safety Monitoring Boards
- Planning for the Developmental Safety Update Report
- Key focus areas during a GCP inspection
Download programme
Please download the relevant programme for your chosen course date.
24 February 2027 - 25 February 2027
Book now
- 24 February 2027 - 25 February 2027
Limited places available - register early to secure your spot
Our courses are CPD accredited by the Faculty of Pharmaceutical Medicine and are recognised by PharmaTrain.