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Clinical Trial Regulatory Requirements Training Course

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 key difference it compares with the Clinical Directive requirements.

14-15 Jul 2022

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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?

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) going live on the 31st January 2022. 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 EU Clinical Trial Regulation (536/2014)
  • The New Clinical Trial Information System
  • How the Clinical Trial Regulation compares with the EU Clinical Trial Directive
  • Clinical trial authorisation
  • Complexities for running paediatric trials
  • Requirements for managing investigational medicinal products
  • Legal aspects of clinical trials
  • Requirements for pharmacovigilance
  • ICH GCP 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: regulatory and ethical approval
  • Assess the most important legal aspects of clinical trials
  • Ensure you comply with pharmacovigilance and adverse event reporting

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.


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
  • Overview of the current EU clinical trials requirements
  • Case study – main issues of the current requirements and why this is being replaced with the Clinical Trial Regulation

The EU Clinical Trial Regulation

  • The Clinical Trial Regulation and implementation texts
  • Overview of the current EU Clinical Trial Directive requirements
  • The key changes compared with the Clinical Trial Directive
  • The new Clinical Trial Information System

Clinical trial regulatory authorisation

  • EU clinical trial application (CTA) for submission in the EU
  • How to apply for the sponsor study number
  • Substantial changes/modification and non-substantial changes
  • Ongoing and end of study reports
  • US regulatory requirements for clinical trials – US IND

Ethics Committee (EC) submissions and approval

  • Completing EC applications
  • Informed consent requirements
  • Ethical considerations for running trials including countries outside of traditional countries

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

  • 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)

Awareness of other recent EU, FDA and international developments in clinical trial requirements

  • Covid regulatory Guidance
  • Clinical trial transparency requirements in the EU – recent 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
  • Requirements for trial master files including electronic TMFs
  • FDA and EU risk-based monitoring guidance
  • FDA guidance on electronic informed consent
  • ICH update

Regulatory Inspection

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


Laura Brown (More...)

Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research at Cardiff University’s School of Pharmacy. Laura has many years’ experience in the pharmaceutical industry, working for companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and as head of a training department and is an international expert on regulatory requirements in clinical research. She was Chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements. She ha written several articles on the requirements of the EU Clinical Trial Regulation, the impact of Brexit on clinical trials and the ICH GCP R2 guideline.

Book now

Book now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
14-15 Jul 2022
Live webinar
UK (London)
14-15 Jul 2022
Live webinar
UK (London)
GBP 1,299.00
EUR 1,859.00
USD 2,098.00
+ VAT @ 20.00%
Enrol now

to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • AbbVie Inc.
  • AnticipSanté SAS
  • Basilea Pharmaceutica International Ltd
  • Biogen
  • Boehringer Ingelheim International GmbH
  • Celgene
  • Chiesi Farmaceutici S.p.a.
  • Clinigen Group PLC
  • Daiichi Sankyo Europe GmbH
  • Faron Pharmaceutical Ltd.
  • Ferrer Internacional
  • GE Healthcare
  • GW Pharmaceuticals
  • H. Lundbeck A/S
  • Hookipa Biotech GmbH
  • Horizon Pharma Ireland Ltd
  • Interdos Pharma BV
  • Ipsen Biopharm Ltd
  • Ipsen Biopharm Ltd.
  • Menarini Ricerche
  • MHRA
  • Novo Nordisk A/S
  • Opiant Pharmaceuticals
  • PharmaLex UK Services Ltd
  • Pharmedd Services Ltd
  • Seqirus
  • SPD Development Company
  • Sun Pharmaceutical Industries
  • Upperton Pharma Solutions
  • Zaklady Farmaceutyczne Polpharma S.A.

Laura was very helpful and went out of her way to make sure we understood everything. This course was regarding EU and FDA only but when asked about UK she made sure she got up some extra information regarding this and was very helpful.

Bethany Roome, Clinical Operations Manager, Torbay Pharmaceuticals, Jan 22

Very on target; Management Forum does an excellent job.

Chiara Delia, Global Regulatory Affairs Specialist, Chiesi Farmaceutici S.p.a., Jan 22

Very well organized in terms of content, very well presented, replies for every single question is addressed by the wonderful speaker and I truly enjoyed it and learned so much. Thank you it was excellent!

Nurit Birenboim, Regulatory Affairs Associate, Ayala Pharmaceutical, Jul 21

Very interactive and stimulating.

Margherita Lerro, Study Manager, Menarini Ricerche, Jul 21

Laura was engaged the whole time and really made the presented topics interesting. She also clearly has a wealth of knowledge within the area, so could answer any questions. I liked that even though the course was online it was possible to have breakout into groups with participants talking and discussing together.

Anna Olevik, Regulatory Affairs Manager, Camurus AB, Jan 21

Laura was passionate, knowledgable and entertaining. I particularly liked the group work sessions, which gave us time to digest and use the information just obtained.

Josy Giordano, Regulatory Affairs Manager, Nestec SA, Jan 20

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, Jan 19

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

Magdalena Golos, Senior Biopharmaceutics and Clinical Team Manager, Zaklady Farmaceutyczne Polpharma S.A., Jan 19

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

Ini Okereke, Regulatory Affairs Manager, GW Pharmaceuticals, Jan 19

[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., Jul 18

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, Jul 18

Fantastic, clear, enthusiastic 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, Jan 18

Very helpful and useful for my job.

Anna Zaragoza, Technician, Grifols S.A., Jan 18

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, Jan 18

Very interesting course, good speaker who was very knowledgable.

Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services, Jan 18