Presented by
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
- 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.
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.
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.
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
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
* 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
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:
