EU (European Union) Clinical Trial Regulation 536/2014 Overview and Implementation Experience Training Course - November 11-12th 2024 and On-Demand
Dublin, July 22, 2024 (GLOBE NEWSWIRE) -- The "EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course" conference has been added to ResearchAndMarkets.com's offering.
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).
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.
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:
Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff
Dr 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.
For more information about this conference visit https://www.researchandmarkets.com/r/1s9a49
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