With the growth of the Pharmaceutical and Biotechnology industry, audits get more and more frequent. The complexity of the investigational products and of the clinical trial protocols amplified the risks for noncompliance. Noncompliance in clinical trials and misreporting of clinical trial results that took place in the last years made the regulatory bodies to multiply the number of audits. On the other part, the sponsors also multiplied the audits from their part in the idea to try to downsize the risk of noncompliance during the trial.
The session will give you practical solutions to get the best results from an audit and the opportunity to grow the image of your team and/or your site.
Areas Covered in the Session:
- ICH guidelines and Good Clinical Practice (GCP)
- Role and responsibilities of clinical trial staff
- Key aspects of the Trial Master File
- Understanding compliance
- Most frequent audit findings
- Audit preparation
- Responding to audit findings
- Developing a CAPA
Who Will Benefit:
- Clinical Trial Sponsors Study Team
- CROs Study Team / Study Managers
- Clinical Team Leads
- CRAs
- Principal Investigators
- Site Managers and Study Coordinators
- New Clinical Research Coordinators
- New Principal Investigators
- Regulatory Compliance Associates and Managers
Calin Enea Popa, MD, CCRA is the Founder and President of Advanced Clinical Research Service Inc. a Canadian full-service CRO that provides CRO services and training to FDA and Health Canada regulated industries. He provides ICH-GCP training and training for FDA and Health Canada regulations. He provides consulting services for the purpose of compliance review, drug accountability, site management, safety review, training site personnel, and to assure the integrity of clinical data. Performed site audits and site audit preparation. Conducted visits to train new CRAs (sign-off visits) and performs online training for CRAs and site staff regarding regulatory compliance and Electronic Data Capture. He works close with companies and sites to prepare them for audits. He holds the CCRA certification from and is an active member of the Association of Clinical Research Professionals.
Thursday, November 3, 2011
10:00 AM PDT | 01:00 PM EDT GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:
- Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations
- Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs
- One stop destination for all your queries and to share and discuss issues, ideas and best practices and
- A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.
