Course overview

Are you up to date with the regulatory requirements for clinical research in the EU and key requirements in the US?

Do you understand the impact of the new requirements of the EU Clinical Trials Regulation?

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the EU Clinical Trial Regulation, ICH GCP R3 update, a brief review of key FDA requirements and update of other recent changes.

This 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 trials Regulation (536/2014) and update
The New Clinical Trial Information System (CIS)
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

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

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
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 including 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.

Enrol or reserve

This course will cover:

Day 1
Day 2

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

EU Clinical Trials Regulation

Update since the implementation of the EU Clinical Trials Regulation and implementation texts
Clinical Trial Transparency
The key changes of the Clinical Trials Regulation
The new Clinical Trials Information System (CTIS) experience

Clinical Trials Regulatory Authorisation

EU clinical trial application (CTA) for submission in the EU
Notices and requests for information requirements
Substantial changes/modification and non-substantial changes
Ongoing and end of study reports including the lay person summary
US regulatory requirements for clinical trials – US IND

CTIS (Clinical Trial Information System)

Overview of CTIS
Roles and responsibilities
CTIS training

Ethics Committee (EC) Approval

EC applications as part of the Clinical Trials National Approval
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 under the Clinical Trials Regulation

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 including:

ICH GCP R3
EMA Inspections: Questions and Answers on Good Clinical Practice (GCP)
Accelerating Clinical Trials in the EU
Clinical trial transparency requirements in the EU
Guidance on real world data
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
FDA to increase racial and ethnic diversity in Clinical Trials

Regulatory Inspection

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

Enrol or reserve

Laura Brown
LB Training and Development Ltd

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

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*

Please contact us for pricing if you are interested in booking 5 or more delegates

16-17 September 2024

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 13871

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 12 Aug

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

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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; and apply only when booking multiple delegates on the same date.