The CTR, which became applicable on 31st January 2022, is directly effective in all EU Member States and introduced the biggest change to the legal framework surrounding clinical trials since the Clinical Trials Directive was implemented. The CTR has already had a global impact as all interventional trials that take place even partially in an EU Member State need to comply with its regulatory requirements, at every stage of the trial life cycle.
This course will provide an essential understanding of the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. It will provide an essential understanding to help with compliance with the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and how these have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022.
This will include explaining how the regulation has harmonised procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial CTIS (Clinical Trial Information System).
Benefits of attending:
- Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
- Understand the new Clinical Trials Information system (CTIS) and experience so far
- Share experiences of implementing the Clinical Trials Regulation
- Discuss the Clinical Trial Regulation implementation documents
- Understand the EU clinical trial authorisation process and experience
Key topics to be covered include:
- Clinical Trials Information System
- Clinical trial authorisation process
- Safety reporting
- Requirements for managing investigational medicinal products
- Clinical trials conducted on children
- Regulatory inspection
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
Background to the EU Clinical Trial Regulation
- The development of European clinical trial legislation
- The framework of clinical trial regulations in Europe
- Experience and challenges so far since Go Live
Overview of the key requirements and changes
Including:
- Roles and responsibilities
- Non-EU sponsors
- Transparency
- Co-sponsorship
Harmonisation templates
- Investigator Curriculum Vitae
- Declaration of interest template
- Site suitability
- Informed consent and patient recruitment procedure
- Compensation for trial participants
Clinical Trial Regulatory Authorisation
- The significant changes in clinical trial approval in the EU
- The new clinical trial authorisation process
- Substantial modifications
- Notices
- Requests for information
- End of study reports
Day 2
The new CTIS (Clinical Trial Information System)
- What is CTIS?
- How to use CTIS
- CTIS training
- Transitioning to the regulation
Clinical Trial Ethical Approval and Informed Consent
- Ethical approval considerations under the Regulation
- Informed consent changes under the regulation
EU Clinical Trial Regulation Documents
- Serious breaches
- Risk-proportionate approaches in clinical trials
- Summaries of clinical trial results for laypersons
- Q&A document
Manufacturing
- GMP requirements
- Key requirements for IMPs and auxiliary medicinal products
- Labelling and packaging
Safety reporting
- Adverse event reporting - requirements and definitions
- Safety reporting requirements
- Safety reporting including RSI (reference safety information)
Clinical Trials in Children
- Considerations for running clinical trials on children
- Assent and consent
- Key differences and requirements for running clinical trials on children compared to adults
Inspection preparation under the new regulation
- GCP and GMP inspection guidelines
- How to prepare for inspection in the EU under the new EU Clinical Trial Requirements
- TMF guideline documentation considerations for inspection
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
This event is ideal for anyone requiring an understanding and update on the EU Clinical Trials Regulation (536/2014). The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.
It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.
