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.

8-9 Jul 2019

& 30-31 Jan 2020

GBP 1,499
EUR 2,099
USD 2,338

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 its 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?
  • 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 children guideline

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 for GMP including labelling
  • Discuss: what do 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?

Awareness 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
  • Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
  • EU medical device regulations
  • EU requirements for Trial Master Files including electronic TMFs
  • FDA and EU risk-based monitoring
  • FDA guidance on electronic informed consent
  • ICH GCP R2 guideline – what are the key requirements?

Brief considerations for preparing for regulatory inspection

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


Laura Brown (8-9 Jul 2019)

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.

Book now

8-9 Jul 2019
8-9 Jul 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
30-31 Jan 2020
30-31 Jan 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

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[The speaker has] ...a solid background related to EU and US regulation and she shares her opinion in a respectul and thoughful way.

Leonardo Roque Pereira, Global Patient Safety Senior Scientist, Ipsen Biopharm Ltd.

The content of the course is quite comprehensive and the information provided is highly helpful and useful.

Mariia Sorokina, Clinical Covigilance Specialist, Aspen Pharma Trading Limited

Very interesting course, good speaker, she was very knowledgable but went over some topics quite quickly

Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services

Content was correct as an overview, duration was 'not too long' and the speaker (Laura Brown) was concise, direct and straight to the point. Very good!

Russell Pursell, Manufacturing Manager, Quay Pharma

Fantastic, clear, enthusiasm and delivered with a little humour which made it feel interesting and relaxed as opposed to too professional and boring! Would definitely recommend!

Vikesh Lad, Pharmaceutical Assessor, MHRA

Very helpful and useful for my job

Anna Zaragoza, Technician, Grifols S.A.

Many thanks for all the additional material.

Gabi Schidler, Senior Manager, Pharmacovigilance, Horizon Pharma GmbH