Clinical Trial Regulatory Requirements

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.

25-26 Jan 2018

& 9-10 Jul 2018

GBP 1,499
EUR 2,099
USD 2,339

Book now

Course overview

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, the new ICH GCP (R2) guideline and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

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

Who should attend?

This course is ideal for anyone requiring an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on the new EU Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, quality assurance (GCP auditors), 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 all other professionals who want to know more about regulations and guidelines covering clinical trials.

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


Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including document management and Data Integrity. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues.

Book now

25-26 Jan 2018
25-26 Jan 2018 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
Enrol now
9-10 Jul 2018
9-10 Jul 2018 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,339.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,027.00
Until 18 May
Enrol now

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