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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
Details
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.
Programme
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.
Presenter
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.
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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
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14-15 Jul 2022 Live webinar 09:30-17:00 UK (London) |
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14-15 Jul 2022 Live webinar 09:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 9 Jun* |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.