Do you understand the impact of the new requirements of the EU Clinical Trials Regulation?
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the EU Clinical Trial Regulation, ICH GCP R3 update, a brief review of key FDA requirements and update of other recent changes.
This interactive programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical and biotechnology companies and study sites.
Key topics to be covered include:
- The EU Clinical trials Regulation (536/2014) and update
- The New Clinical Trial Information System (CIS)
- Clinical trial authorisation
- Complexities for running paediatric trials
- Requirements for managing investigational medicinal products
- Legal aspects of clinical trials
- Requirements for pharmacovigilance
- ICH GCP R3 update
- Regulatory inspections
Benefits of attending
- Decipher the framework of clinical trial regulations and guidelines in Europe
- Gain an update on the new EU Clinical Trial Regulation 536/2014
- Review key FDA requirements
- Understand clinical trial authorisations
- Assess the most important legal aspects of clinical trials
- Ensure you comply with pharmacovigilance and adverse event reporting
Certifications
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
Overview of the framework of clinical trial regulations in Europe
- Background to the history of clinical trial legislation
- Pharmaceutical clinical trial legislation - EudraLex 10
- ICH and its importance
- Key FDA requirements that differ from EU requirements
EU clinical trials regulation
- Update since the implementation of the EU Clinical Trials Regulation and implementation texts
- Clinical Trial Transparency
- The key changes of the Clinical Trials Regulation
- The new Clinical Trials Information System (CTIS) experience
Clinical trials regulatory authorisation
- EU clinical trial application (CTA) for submission in the EU
- Notices and requests for information requirements
- Substantial changes/modification and non-substantial changes
- Ongoing and end of study reports including the lay person summary
- US regulatory requirements for clinical trials - US IND
Day 2
CTIS (Clinical Trial Information System)
- Overview of CTIS
- Roles and responsibilities
- CTIS training
Ethics Committee (EC) approval
- EC applications as part of the Clinical Trials National Approval
- Informed consent requirements
- Ethical considerations for running trials including countries outside of traditional countries
Running clinical trials in children: the paediatric plan and ethical considerations
- The EU regulation on paediatric medicines and the paediatric committees
- Ethical considerations for clinical trials in children guideline
Brief overview of legal aspects of clinical trials
- Data protection - GDPR
- Enforcement and sanctions
- Liability and insurance
- Contracts
Investigational medicinal product under the clinical trials regulation
- GMP requirements and the role of the Qualified Person
- Labelling requirements
- Discuss: what inspectors expect for compliance
Pharmacovigilance and adverse event reporting
- Safety reporting definitions and requirements
- What are the reporting requirements for SUSARs, adverse events and adverse reactions?
- RSI (reference safety information)
Awareness of other recent EU, FDA and international developments in clinical trial requirements including:
- ICH GCP R3
- EMA Inspections: Questions and Answers on Good Clinical Practice (GCP)
- Accelerating Clinical Trials in the EU
- Clinical trial transparency requirements in the EU
- Guidance on real world data
- EU medical device regulations
- Requirements for trial master files including electronic TMFs
- FDA and EU risk-based monitoring guidance
- FDA guidance on electronic informed consent
- FDA to increase racial and ethnic diversity in Clinical Trials
Regulatory inspection
- How to prepare for inspection
- What questions do inspectors ask? Tips on how to answer these.
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 course is ideal for anyone requiring either an overview or refresher of the current clinical trial regulatory and guideline requirements including the new EU Clinical Trial Regulation. It will be particularly relevant for those working in regulatory, clinical research, clinical operations, project management and 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/support clinical trial personnel (such as clinical trial supply, pharmacovigilance, quality assurance, document management, legal), regulatory authorities, and any other professionals who want to know more about regulations and guidelines covering clinical trials.
