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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 existing Directive requirements.
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 existing Directive requirements. 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 current requirements of the EU Clinical Trials Directive
- The EU Clinical Trial Regulation (536/2014)
- The impact of Brexit
- Clinical trial authorisations
- Complexities for running paediatric trials
- Requirements for managing investigational medicinal products
- Legal aspects of clinical trials
- Requirements of pharmacovigilance
- ICH 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
Understand the current framework of clinical trial regulations in Europe
- Pharmaceutical clinical trial legislation – EudraLex 10 contents explained
- ICH and its importance
- Key FDA requirements which differ from EU requirements
- The impact of Brexit
Overview of the current EU clinical trials requirements
- The key requirements of the EU Clinical Trials Directive
- Case study – main issues of the Clinical Trials Directive and why this will be replaced with the Clinical Trial Regulation
The new EU Clinical Trial Regulation
- Update on the new Clinical Trial Regulation, timescale for applications, implementing acts, EU portal and database and new documentation
- What key changes will be introduced?
- Implementation and compliance
Clinical trial regulatory authorisation and amendments
- How to apply for the EudraCT number
- Current requirements for an EU clinical trial application (CTA) and how this will change with the new Clinical Trial Regulation
- Substantial amendments and non-substantial amendments
- US regulatory requirements for clinical trials – US IND
Ethics Committee (EC) submissions and approval
- Roles and responsibilities: sponsor and investigators
- Completing EC applications
- Informed consent requirement
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
- 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?
Awareness of other recent EU and FDA developments in clinical trial requirements
- 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
- New EU requirements for trial master files including electronic TMFs
- New FDA and EU risk-based monitoring guidance
- FDA guidance on electronic informed consent
- ICH update
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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27-28 Jan 2022 Live webinar |
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27-28 Jan 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 23 Dec* |
Enrol now
to attend Live webinar |
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14-15 Jul 2022 Live webinar |
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14-15 Jul 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 9 Jun 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code