DUBLIN--(BUSINESS WIRE)--The "GCP and Clinical Research Update - Hot Inspection Topics" conference has been added to ResearchAndMarkets.com's offering.
This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented
Clinical research is a constantly evolving field and the regulatory requirements are regularly being updated. In order to stay up to date and maintain your GCP knowledge, it is important to receive regular training.
This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented. Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, data integrity and the impact of GDPR on clinical trials. The programme will discuss inspection findings and common failings in these new areas and how these should be addressed.
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:
- Discuss recent developments in GCP and clinical trial legislation and guidance
- Identify common audit and inspection findings and discuss how to prevent these occurring
- Understand the impact on clinical trials of recent GCP principles and regulatory standards such as the EU Clinical Trial Regulation (536/2014) and GDPR (2016/679)
- Clarify requirements for clinical QMS and QTLs (quality tolerance limits)
Who Should Attend:
The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance 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.
Brief review of regulatory authority inspections findings
- Hot inspection topics, including EMA, MHRA and FDA findings
New EU Clinical Trial Regulation (536/2014) - overview and update including new supporting documents
- Review of the key changes including the new clinical trial application process
- Update on the additional guidance and directives
- Compliance considerations for serious breaches
ICH GCP E6 R2 - practical examples of implementation to comply with inspectors' expectations
- Update on the revision of ICH GCP R2
- Practical implications of the key changes
- Requirements for clinical QMS and QTLs (quality tolerance limits)
- Hot topics discussion, including procedures for certified copies'
Oversight - how to demonstrate and document for CRO oversight and investigator oversight
- How to demonstrate oversight of the investigator and expanded responsibilities under ICH GCP R2
- How to meet inspectors' expectations for sponsor oversight of CROs and other vendors
Risk management - new requirements for GCP compliance
- Quality risk management requirements
- Risk-based monitoring
- Examples of risk-based tools to demonstrate compliance
- The latest requirements and new regulatory guidance from MHRA, FDA, EU
- Computer System Validation
- Avoiding data integrity breaches
- The TMF Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (2017)
GDPR (General Data Protection Regulation) requirements for clinical trials
- Penalties for non-compliance and reporting serious data breaches
- Overview of key requirements including informed consent, contracts with suppliers, responsibilities of data controllers and data processors
- Preparation of data protection impact assessments for clinical trials
Q & A and other hot topics
- Brief overview of other recent GCP developments including electronic informed consent
Summary, action plans and final Q & A
Dr. Laura Brown
Pharmaceutical Management and Training Consultant
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
For more information about this conference visit https://www.researchandmarkets.com/r/8fa4i7