EU Clinical Trials Directive (Workshop with Certification)

Description

The conduct of a clinical trial is governed closely by stipulated regulations and regional bodies world-wide such as the EMEA in Europe, FDA in the United States and Pharmaceutical and Medical Devices Agency (PMDA, SOGO-KIKO) in Japan.  Regional regulatory bodies such as those in Europe and Japan ascertain compliance from a local-GCP perspective and the fundamental ethics of GCP are enforced through local GCP compliant laws. Pharmaceutical companies or CROs that are involved in the conduct of clinical trials across these regions should be aware of such global and regional cGCP compliance regulations. The conduct of clinical research and trials in Europe has been formalized since the introduction of the European Union’s Clinical Trials Directive (EUCT Directive). These directives provide guidelines related to issues such as the selection and protection of subjects, trial ethics, trial commencement procedures, information exchange procedures, AE/SAE reporting, labeling, etc. The EUCT Directive was formally passed as a EU legislation in 2003 with the objective that all EU member states (currently 27) follow and interpret the EU legislation in an unified manner. The uniform interpretation in practice can be discussed with case studies across these regions.

The seed for the formation of EUCT Directive was ICH's implementation of CGP. Instead of following a plethora of rules for EU member states, the EUCT Directive was passed to harmonize CT initiatives in all EU member states. In this context, a comprehensive workshop has been created that directly benefits pharmaceuticals and CROs with a European presence.

Backed by sustained research and efforts to keep up with current trends, this workshop presents a wealth of information and is offered by our distinguished Ph.D-level clinical research faculty. A comprehensive module-based assessment of students is also conducted. The instructional material contains relevant presentations, example scenarios and a comprehensive module-based assessment of students. Issues covered include the pre-clinical trial formalities to be completed in EU, the various EU directives to be followed in the conduct of the clinical trial and the role of EudraCT (European Union Drug Regulating Authority for Clinical Trials) database.  This workshop also presents an overview of other EU related systems and procedures such as EudraCT, EudraLex and EudraVigilance.

Pre-requisites

Good understanding of the drug development process and clinical trial fundamentals. This is also the starting point for those who would like to be introduced to the area of GCP, global clinical research and management of CT in Europe.

Target Audience

Junior/entry level pharmaceutical and CRO employees with presence in Europe/USA, EMEA-associated pharmaceutical personnel such as Clinical Research Associates (CRAs), Drug Safety, Regulatory and Clinical personnel, Clinical Study Coordinators, Principal Investigators, Statistical Data Managers, Regulatory Submission System Managers

Learning Outcome

The participants are expected to gain knowledge of the following:

• How to initiate and conduct a clinical trial in EU based on 2001/20/EC guidelines?
• Processes and procedures associated with each directive
• Key differences between the US CT guidelines and the EU directives
• Awareness of EU related systems and procedures around EudraCT, EudraLex, EudraVigilance, etc.

Topics of Study

• The evolution of European Medicines Agency (EMA) for the evaluation of medicinal products in Europe and its precursor
• An overview of the differences between the US and EU directives in the approval process, e.g., approval of multiple studies for a specific drug versus approval for a specific drug
• How to initiate a clinical trial in EU based on 2001/20/EC directives? This topic covers procedures involved in formal creation of the CT Application, follow-up, divisional agencies, etc.
• The local and national EU agencies involved in the approval process of the clinical trial application and plans
• Overview and practical implications of each directive in 2001/20/EC passed by the European Parliament and the Council. This section covers the regulations and administrative directives for the EU member states from a GCP perspective for the conduct of clinical trials on medicinal products for human use.
• Current EMEA statistics related to on-going trials
• Amendment procedures in EU for a clinical trial; demonstration of some example cases
• An overview of the EMEA-EudraCT database
• An overview of cross-functional EU and global agency relationships
• An overview of related EU directives such as:
• EudraLex Regulations for clinical trials, their relationship with EU Clinical Trials Directive and specific EudraLex sections that deal with investigational medicinal products for human use in clinical trials
  EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) for reporting SUSARS, ICSRs, etc.