Competencies acquired at the end of the training :
| Understand what constitutes a serious breach of GCP. |
| Know how to identify, manage and report serious breaches under European Union (EU) and United Kingdom (UK) legal requirements. |
| Understand processes and roles and responsibilities of different parties for handling of serious breaches. |
| Identify examples of breaches that may require reporting. |
80.00€
The requirements for reporting of serious GCP non-compliance existed in many countries for a number of years. The UK formalization of this requirement in 2006 and now the EU CTR require the sponsor of the clinical trial to ensure appropriate management of serious breaches in compliance.
We created this course to help you understand the current requirements for serious breach reporting depending on the legislation that you follow.
4 sections, all of them containing interactive exercises and quizzes to reinforce acquisition of the key take-home messages :
1. What is a Serious Breach and the regulatory landscape of GCP non-compliance.
2. Key Reporting process steps for the EU and UK, including breach evaluation, who should notify, how to report the breach and timelines for reporting.
3. Key Responsibilities of the Sponsor, CRO and the investigator in the management of Serious Breaches.
4. Examples of serious breaches in different areas.
Maria Sliwowska,
ObelysQ SA Switzerland
Maria is a physician by education, holds a degree in epidemiology, and is currently certified as Information Privacy Professional/Europe (CIPP/E). For the past 20 years, she has worked in various Quality Assurance roles across GCP, GCLP, GVP, CSV and data privacy and advanced analytics space.
Maria had the opportunity to support various Health Authority inspections, perform audits globally and manage auditing training. More recently Maria has been involed in helping translate the interactions of the clinical trial and data privacy regulations into pragmatic and compliant privacy programs.
Maria has worked the past for Biotech companies, big pharmas, clinical research organizations, and non-governmental organizations. The quality journey took Maria from Poland, through Germany and the UK to Switzerland.
| Objectives | The objectives of this course are to provide you with the knowledge of how to manage a serious breach of GCP and report it according to the European Union (EU) and United Kingdom (UK) legal requirements |
|---|---|
| Duration of the of the course | 30 minutes |
| Language | English |
| Certification | A certificate of completion will be delivered at the end of the training. |
| Targeted audience | Clinical research professionals involved in the conduct of clinical trials in EU: Pharma sponsors, CROs, academic sponsors, hospital clinical research units. From operational to management levels whether the organization is located in the EU or not. |
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