Monitoring Safety in Clinical Trials and Drug Development (Hybrid Event)

Course Overview

The way in which clinical trials are conducted in the European Union (EU) is undergoing a major change, due to the introduction of the Clinical Trial Regulation (CTR) from 31 January 2022. By 31 January 2025, all new clinical trials must be regulated under the new EU CTR. This new regulation will enhance the requirements within the previous Clinical Trial Directive with harmonised clinical trial assessments and supervision processes throughout the EU. There will be consistent rules for conducting clinical trials within the EU, increased transparency of information on clinical trial and increased efficiency with enhanced collaboration, information sharing and decision making.

While this new guidance will apply within the EU, many clinical trial programs are run globally and so we do also need to consider other global Clinical Trial requirements namely the FDA requirements and where these may differ to the EU. In addition, post authorisation GVP provides specific guidance on the management of Post Authorisation Safety Studies, which also need to be evaluated when implementing a new post authorisation study.

Our Monitoring Safety in Clinical Trials and Drug Development course provides 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 and guidance both pre- and post-authorisation.

Please note, the course dates and programme may be subject to change.
The in-person session of this course will only proceed when a minimum number of participants is met. Should this number not be reached, the registered participants will be notified at least three weeks prior to the course.

Our courses are recognised by PharmaTrain.

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 courses work

• Taught over two days
• A combination of lectures and interactive workshops
• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)
• Full access to PDFs of the presentations afterwards
• Use this course as part of your Continuing Professional Development (CPD)
• Refreshments and lunch provided (in-person delegates)
• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

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

Key topics

Programmed features:

• The Clinical Trial Regulation – new requirements and potential challenges
• 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
• Reporting to Eudravigilance Clinical Trial Module – practicalities and challenges
• Key focus areas during a GCP inspection

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Academic

  £775 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - In-Person

• Standard

  £952 + VAT

  Virtual

• Standard

  £1190 + VAT

  In-Person

Registration fees include electronic access to all course materials. Lunch and refreshments are provided for those attending in-person.

Book now

• 24 January 2024 - 25 January 2024

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  UK Based International

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