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Management Forum

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.

★★★★★ "Very on target; Management Forum does an excellent job."

14-15 Jul 2022

Need help?  Enrol now

  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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.

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The Clinical Trial Regulatory Requirements course will cover:

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.

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Laura Brown

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.

More details

Book Clinical Trial Regulatory Requirements Live online training

NEW higher discounts for multiple bookings - 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 online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11681

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 09 Jun

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Clinical Trial Regulatory Requirements training course


Very on target; Management Forum does an excellent job.

Jan 27 2022

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

Jan 27 2022

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

Jul 5 2021

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 5 2021

Very interactive and stimulating.

Margherita Lerro
Study Manager, Menarini Ricerche

Jan 28 2021

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 30 2020

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 24 2019

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 24 2019

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 24 2019

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

Jul 9 2018

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

Jan 25 2018

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 25 2018

Very helpful and useful for my job.

Anna Zaragoza
Technician, Grifols S.A.

Jan 25 2018

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 25 2018

Very interesting course, good speaker who was very knowledgable.

Chantal Mutsaers
Regulatory Affairs Scientist, Phara Plus Life Science Services

Jul 9 2018

[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 10 2017

Many thanks for all the additional material.

Gabi Schidler
Senior Manager, Pharmacovigilance, Horizon Pharma GmbH

United Kingdom

  • Torbay Pharmaceuticals
  • AbbVie Inc.
  • Biogen
  • Cancer Research UK
  • Chugai Pharma Europe Ltd.
  • Clinigen Group PLC
  • CROPrime Ltd
  • EUSA Pharma
  • GE Healthcare
  • GW Pharmaceuticals
  • Ipsen Biopharm Ltd
  • Ipsen Biopharm Ltd.
  • Janssen Cilag Ltd
  • MHRA
  • Mundipharma Research Ltd
  • Mundipharma Research Ltd.
  • Opiant Pharmaceuticals
  • PharmaLex UK Services Ltd
  • Pharmedd Services Ltd
  • Quay Pharma
  • Reckitt Benkiser
  • Replimune
  • SPD Development Company
  • ThromboGenics NV
  • Upperton Pharma Solutions
  • Zogenix International Ltd

Germany

  • Bavarian Nordic
  • Bayer AG
  • Boehringer Ingelheim International GmbH
  • Daiichi Sankyo Europe GmbH
  • Horizon Pharma GmbH
  • Life Molecular Imaging GmbH
  • Myelo Therapeutics GmbH

Switzerland

  • Basilea Pharmaceutica International Ltd
  • Celgene
  • F. Hoffmann-La Roche Ltd.
  • MSD Innovation & Development GmbH
  • Nestec SA
  • Santhera Pharmaceuticals (Switzerland) Ltd

France

  • Anticipsante
  • Institut de Recherches Internationales Servier
  • Institut de Recherches Internationales Servier (I.R.I.S.)
  • Janssen Cilag

Denmark

  • H. Lundbeck A/S
  • Novo Nordisk
  • Novo Nordisk A/S

Italy

  • Chiesi Farmaceutici S.p.a.
  • Menarini Ricerche
  • Seqirus

Spain

  • Ferrer Internacional
  • Grifols S.A
  • Grifols S.A.

Belgium

  • Phara Plus Life Science Services
  • PhaRa PLUS Life Science Services (BVBA)

Ireland

  • Aspen Pharma Trading Limited
  • Horizon Pharma Ireland Ltd

Netherlands

  • Interdos Pharma BV
  • Sun Pharmaceutical Industries

Sweden

  • BioGaia AB
  • Camurus AB

United States of America

  • MEI Pharma
  • Regeneron Pharmaceuticals, Inc.

Austria

  • Hookipa Biotech AG

Finland

  • Faron Pharmaceutical Ltd.

Israel

  • Ayala Pharmaceutical

Korea, Republic Of

  • Asan Medical Center

Poland

  • Zaklady Farmaceutyczne Polpharma S.A.

Saudi Arabia

  • Saudi Food and Drug Authority

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Run Clinical Trial Regulatory Requirements Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training expert Aleksandra Beer to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy