Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training.
This must-attend course provides a review of recent changes to relevant guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3
This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors.
Benefits of attending
- Be updated on ICH GCP R3
- Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations
- Review the requirements of clinical trail essential documentation
- Identify common audit and inspection findings to help prepare for inspection
- Understand the EU Clinical Trial Regulation requirements
- Clarify requirements for data integrity and governance
- Explore technology advances in clinical trials
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Brief review of regulatory authority inspections findings
EMA, MHRA and FDA findings
Latest ICH GCP E6 R3 guideline
- Develop an understanding of the ICH GCP E6 R3, focusing on the critical updates and revisions
- The key new requirements introduced by the latest E6 R3 Annex 1 guideline
- Risk-proportionate approaches
- What will impact on running clinical trials
- ICH E8 implications for ICH GCP E6 R3
Data integrity governance
- What inspectors look for
- MHRA integrity guidance compliance
- ICH GCP E6 R3 Governance requirements
EU Clinical Trial Regulation (536/2014) update
- Key requirements and documentation
- Clinical Trials Information System (CTIS)
- EU clinical trial authorisation
- Serious Breaches
Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3
- TMF structure, content, security, control, maintaining the TMF and storage, e-TMFs, archiving and retention
- ICH GCP E6 R3 - recommended format for compliance
Awareness update from EU and FDA
- EU
- EMA Guidance on validation & qualification of computerised systems
- European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
- Artificial intelligence reflection guidance in lifecycle
- Stronger enforcement of the GDPR in cross-border cases
- Real-world data
- FDA
- Guidance for industry: considerations for the use of real-world data
- FDA guidance on enhancing the diversity of clinical trials
- A risk-based approach to monitoring of clinical investigations
- Informed consent guidance for IRBs, clinical investigators and sponsors
Digitalisation and technology advances and GCP
- Technology innovations in clinical research
- Electronic informed consent
- Apps, medical devices and mobile technologies in clinical trials
- Artificial intelligence
- Decentralised clinical trials
Conclusion and final Q&A
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
The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. It will also be of interest to those departments who liaise/support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials.
