Dublin, Dec. 07, 2018 (GLOBE NEWSWIRE) -- The "Clinical Trial Regulatory Requirements" conference has been added to ResearchAndMarkets.com's offering.

Are you up to date with the regulatory requirements for clinical research?

Do you understand the impact and new requirements of the EU Clinical Trials Regulation and delegated acts and guidelines?

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

Attending this course will help ensure you are familiar with the regulatory requirements for running clinical trials and with these recent developments. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical, biotechnology companies and study sites.

Key topics to be covered include:

• The current requirements of the EU Clinical Trial Directive
• The EU Clinical Trial Regulation (536/2014)
• The impact of Brexit
• Clinical trial authorisations
• Complexities for running paediatric trials
• Requirements for managing investigational medicinal products
• Legal aspects of clinical trials
• Requirements of pharmacovigilance
• New ICH GCP R2 guideline requirements
• Regulatory inspection

Why you should attend:

• Decipher the framework of clinical trial regulations and guidelines in Europe
• Gain an update on the new EU Clinical Trial Regulation and the recently finalised ICH GCP R2 Guideline
• Discuss the impact of Brexit
• Understand clinical trial authorisations: regulatory and ethical approval n Realise the most important legal aspects of clinical trials
• Ensure you comply with pharmacovigilance and adverse event reporting
• Make certain you are prepared for regulatory inspections

Agenda

Programme Day One

Understand the current framework of clinical trial regulations in Europe

• Pharmaceutical clinical trial legislation - EudraLex 10 contents explained
• ICH and it's importance
• Key FDA requirements which differ from EU requirements, e.g financial disclosure, 1572
• Potential impact of Brexit discussion

Overview and review of key areas of the EU Clinical Trial Directive

• The key requirements of the GCP Directive
• Case study - What have been the main problems of working with the Clinical Trial Directive and why is the new Clinical Regulation coming in?

Brief overview of the GCP Directive

• GCP - Which GCP standard? ICH GCP and the CT Directive

The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive

• Update on the new Clinical Trial Regulation, implementing acts and EU portal and database and new documentation
• Key changes which will come in
• Group discussions on what will the main activities / issues be?

Clinical trial regulatory authorisation and amendments

• How to apply for the EudraCT number
• Current requirements for an EU

Clinical Trial Application (CTA) and how this will change with the new Clinical Trial Regulation

• Substantial amendments and non-substantial amendments
• Regulatory requirements for clinical trials - US IND

Ethics Committee (EC) submissions and approval

• The role of the sponsor and investigators in completing the EC applications
• Informed consent requirement
• Acceptability of global data to GCP

Programme Day Two

Running clinical trials in children: the paediatric plan and ethical considerations

• The EU regulation on paediatric medicines and the paediatric committees
• Ethical considerations for clinical trials performed in children guideline compared with adults

Brief overview of legal aspects of clinical trials

• Data protection
• Enforcement and sanctions
• Liability
• Contracts

Investigational medicinal product

• GMP requirements and the role of the Qualified Person
• The key requirements of the GMP Directive and Annex 13
• Requirements for labelling
• Consider what inspectors expect for compliance

Pharmacovigilance and adverse event reporting

• Safety reporting definitions and requirements
• What are the reporting requirements for SUSARs, adverse events and adverse reactions?

Brief overview of other recent EU and FDA developments in clinical trial requirements including:

• Clinical Trial Transparency Requirements in the EU - new EMA policy on publication of clinical data
• EMA reflection papers including, risk-based quality management of clini- cal trials, data from third countries, Trial Master Files including electronic TMFs
• EU data protection
• FDA risk-based approaches to clinical trial monitoring
• FDA guidance electronic Informed Consent and emergency consent
• New ICH GCP (R2) Guideline - what are the key new requirements?

Brief considerations for preparing for regulatory inspection

• How to prepare for inspection
• What questions inspectors may ask

Summary and close

For more information about this conference visit https://www.researchandmarkets.com/research/5ncrq8/2day_course?w=12

CONTACT: ResearchAndMarkets.com
         Laura Wood, Senior Press Manager
         press@researchandmarkets.com
         For E.S.T Office Hours Call 1-917-300-0470
         For U.S./CAN Toll Free Call 1-800-526-8630
         For GMT Office Hours Call +353-1-416-8900
Related Topics: Clinical Trials, Medical Law 

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.