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GCP Update: EU Clinical Trial Regulation 536/2014 and ICH GCP R2

Regulatory inspectors expect those involved in clinical trials to be aware of the both the EU Clinical Trial regulation and the new ICH GCP R2 guideline for controlling clinical trials. This highly practical 2 days course will give you the essential knowledge of these important recent requirements for running clinical trials. This training will equip you with useful tools and techniques to successfully apply the new requirements to your trials. Our course will highlight the most important of these key requirements and changes from both these key documents and help you to ensure the acceptance of clinical trial data by the regulatory authorities and GCP compliance for inspections.

Turning 'Theory' into 'Practice'?

You will find out how these changes will impact trials now and in the future for both Biopharmaceutical companies and study sites. Our course leader has many years’ experience of QA in the Pharmaceutical Industry. She has worked for several companies including Glaxo Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Clinical Research Manager, Audit Director and as Head of a Training Department. She is an international expert on GCP and QA requirements and assisted organisations to implement the new requirements. She is author of SCRIP’s latest GCP guide, and several articles on the new EU Clinical Trial Regulation, ICH GCP R2 and implications for Brexit for the pharmaceutical industry.

Who should attend?

Meet the new international GCP standard of ICH GCP E6 Revision 2 and the EU Clinical Trials Regulation 536/2014 which will replace the European Clinical Trials Directive (2001/20/EC)

Key areas to be covered in the programme and documentation

Understand the Framework of EU Clinical TrialRegulations in Europe
• Pharmaceutical clinical trial legislation
• EU Clinical Trial Regulation 536/2014
• Overview the changes of the new ICH GCP (R2) guidelineand how these will impact on clinical trials

EU Clinical Trial Regulation and How this will Replacethe EU Clinical Trials Directive
• Update on the New Clinical Trial Regulation
• Compare the features of the new regulation with current EU directives
• Overview of the major new requirements of the Clinical Trial Regulation
• Archiving of essential documents
Case study: Demonstrating why the changes are needed

Clinical Trials Authorisation: Regulatory Approvaland Ethical Approval
• The single approval portal
• Content of applications
• Clinical trial transparency
• Progress reporting
Practical exercise: Completing a CTA (clinical trial application)

Subject protection
• Informed consent
• Ethics Committee (EC)Submissions and Approval
• Reporting of serious breaches and urgent safety measures
Case study: How informed consent requirements were not compliedwith and what the consequences are

Investigational Medicinal Product
• GMP Requirements
• Role of the Qualified Person
• Labelling
Practical Exercise: Considering what an inspector would look forto comply with the regulations and guidelines

Pharmacovigilance and Adverse Event Reporting
• Adverse Event reporting
• Requirements and definitions
• Safety reporting requirements
Practical Exercise: Understanding the different safety definitions

Investigator study site oversight requirements to comply with ICHGCP R2
• Investigator responsibilities
• Ensuring appropriate qualifications
• Implementing a quality management system
• Critical processes and data identification
• Risk process implementation
Discussion: Sharing best practice of QMS

Oversight of CROs
• Implications for the selection
• Management and performance of CROs
• Sponsor oversight
• Sponsor quality management
Practical Exercise: Understanding how to document oversight

Risk- based monitoring
• Risk based monitoring approaches
• Monitoring plans and electronic systems
• Validation processes
• SOPs
• Electronic trial data handling
Case study: Example of RBM in leading pharmaceutical company

Non Compliance of GCP and CAPA
• Corrective and preventative action (CAPA)
• Non compliance
• Trial Master File
• What additional documents should the TMF contain?

Benefits to you

Course outcomes
• Exploring the latest GCP requirements
• Minimise risks by applying the new requirements for running clinical trials
• Achieving better results of implementing the ICH GCP R2 changes
• Learning how to apply the requirements for your trials
• Ensuring the acceptance of clinical trial data by the regulatory authorities
• Improving GCP compliance for inspections

Companies already benefiting include:

Duration of Course

2 Day Course

Course details

24 & 25 May 2018, London, UK, PT3731

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"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac