Clinical Trial Regulatory Requirements Training Course: Understand the Impact of the New EU Requirements in the United States

Dublin, Aug. 17, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trial Regulatory Requirements Training Course" conference has been added to's offering.

Are you up to date with the regulatory requirements for clinical research in the EU and key requirements in the US?

Do you understand the impact of the new requirements of the EU Clinical Trials Regulation?

This course is ideal for anyone requiring either an overview or refresher of the current clinical trial regulatory and guideline requirements including the new EU Clinical Trial Regulation.

It will be particularly relevant for those working in regulatory, clinical research, clinical operations, project management and quality assurance (GCPauditors); vendor/CRO professionals; study sites; and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise/support clinical trial personnel (such as clinical trial supply, pharmacovigilance, quality assurance, document management, legal), regulatory authorities, and any other professionals who want to know more about regulations and guidelines covering clinical trials.

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 CTIS (Clinical Trial Information system) one year after going live. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

This interactive programme 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 and biotechnology companies and study sites.

Key topics to be covered include:

  • The EU Clinical trials Regulation (536/2014) and update
  • The New Clinical Trial Information System (CIS)
  • Clinical trial authorisation
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements for pharmacovigilance
  • ICHGCP R3 update
  • Regulatory inspections

Benefits of attending

  • Decipher the framework of clinical trial regulations and guidelines in Europe
  • Gain an update on the new EU Clinical Trial Regulation 536/2014
  • Review key FDA requirements
  • Understand clinical trial authorisations
  • Assess the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting


Day 1

Overview of the Framework of Clinical Trial Regulations in Europe

  • Background to the history of clinical trial legislation
  • Pharmaceutical clinical trial legislation - EudraLex 10
  • ICH and its importance
  • Key FDA requirements that differ from EU requirements

The New EU Clinical Trials Regulation One Year After Go Live

  • Update one year after the Go Live implementation of the new Clinical Trials Regulation and implementation texts
  • Clinical Trial Transparency
  • The key changes of the Clinical Trials Regulation
  • The new Clinical Trials Information System (CTIS) experience

Clinical Trials Regulatory Authorisation

  • EU clinical trial application (CTA) for submission in the EU
  • Notices and requests for information requirements
  • Substantial changes/modification and non-substantial changes
  • Ongoing and end-of-study reports including the lay person summary
  • US regulatory requirements for clinical trials - US IND

Ethics Committee (EC) Approval at National Level

  • EC applications as part of the Clinical Trials National Approval
  • Informed consent requirements
  • Ethical considerations for running trials including countries outside of traditional countries

Day 2

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 in children guideline

Brief Overview of Legal Aspects of Clinical Trials

  • Data protection - GDPR
  • Enforcement and sanctions
  • Liability and insurance
  • Contracts

Investigational Medicinal Product under the Clinical Trials Regulation

  • GMP requirements and the role of the Qualified Person
  • Labelling requirements
  • Discuss: 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?
  • RSI (reference safety information)

The CTIS (Clinical Trial Information System)

  • What is CTIS?
  • How to use CTIS
  • Transitioning trials

Awareness of Other Recent EU, FDA and International Developments in Clinical Trial Requirements including:

  • ICH GCP R3
  • EMA Inspections: Questions and Answers on Good Clinical Practice (GCP)
  • Reflection Paper on the Use of Interactive Response Technologies with Particular Emphasis on the Handling of Expiry Dates
  • Accelerating Clinical Trials in the EU
  • Covid regulatory Guidance
  • Clinical trial transparency requirements in the EU
  • Guidance on real world data
  • EU medical device regulations
  • Requirements for trial master files including electronic TMFs
  • FDA and EU risk-based monitoring guidance
  • FDA guidance on electronic informed consent
  • FDA to increase racial and ethnic diversity in Clinical Trials

ICH update

Regulatory Inspection

  • How to prepare for inspection
  • What questions do inspectors ask? Tips on how to answer these.


Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff

Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017.

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