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.

30-31 Jan 2020

& 6-7 Jul 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 Trial 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.

The 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 current requirements of the EU Clinical Trials 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
  • ICH GCP R2 guideline requirements
  • Regulatory inspections

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 536/2014
  • Discuss the impact of Brexit
  • Understand clinical trial authorisations: regulatory and ethical approval
  • Assess the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting
  • Understand key FDA requirements

Who should attend?

This course is ideal for anyone requiring either an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on 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 (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 any 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

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

  • The key requirements of the GCP Directive
  • Case study – main issues of the Clinical Trials Directive and why this will be replaced with the Clinical Trial Regulation

The new EU Clinical Trial Regulation

  • Update on the new Clinical Trial Regulation, implementing acts, EU portal and database and new documentation
  • Key changes which will be introduced
  • Group discussion – implementation, compliance and issues of clinical trial implementation texts including serious breaches, TMF, layman summary and AMPs

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

  • Roles and responsibilities: sponsor and investigators
  • Completing EC applications
  • Informed consent requirement

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 in 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 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

  • 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

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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

Book now

30-31 Jan 2020
30-31 Jan 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
6-7 Jul 2020
6-7 Jul 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

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Previous customers include...

  • AbbVie Inc.
  • AnticipSanté SAS
  • Asan Medical Center
  • Aspen Pharma Trading Limited
  • Bavarian Nordic
  • Biogen
  • Boehringer Ingelheim International GmbH
  • Cancer Research UK
  • Celgene
  • CROPrime Ltd
  • EUSA Pharma
  • F. Hoffmann-La Roche Ltd.
  • GE Healthcare
  • Grifols S.A.
  • Grifols, S.A
  • GW Pharmaceuticals
  • Hookipa Biotech GmbH
  • Ipsen Biopharm Ltd
  • Ipsen Biopharm Ltd.
  • MHRA
  • Mundipharma Research Ltd
  • Mundipharma Research Ltd.
  • Novo Nordisk
  • PhaRa PLUS Life Science Services (BVBA)
  • Quay Pharma
  • Regeneron Pharmaceuticals, Inc.
  • Santhera Pharmaceuticals (Switzerland) Ltd
  • Saudi Food and Drug Authority
  • Sun Pharmaceutical Industries
  • Zaklady Farmaceutyczne Polpharma S.A.

Laura was very knowledgable and made the course interactive. We had several group discussions which made the topics clear. The course was excellent and met the criteria I was looking for.

Paul Kelsall, Director of Clinical Manufacturing, Upperton Pharma Solutions

The course is very useful for people new to the field and also the more experienced. The speaker was Laura very knowledgeable and open to even the most basic questions on the topic presented.

Ini Okereke, Regulatory Affairs Manager, GW Pharmaceuticals

Useful and recommended however for those who are advanced in that topic

Magdalena Golos, Senior Biopharmaceutics and Clinical Team Manager, Zaklady Farmaceutyczne Polpharma S.A.

[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

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

Very helpful and useful for my job

Anna Zaragoza, Technician, Grifols S.A.

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

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

Many thanks for all the additional material.

Gabi Schidler, Senior Manager, Pharmacovigilance, Horizon Pharma GmbH