Including the requirements of the new EU Clinical Trial Regulation and new ICH GCP (R2) guideline
Are you up to date with the regulatory requirements for clinical research?
Do you understand the impact and new requirements of the EU Clinical Trials Regulation and delegated acts and guidelines?
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.
Attending this course will help ensure you are familiar with the regulatory requirements for running clinical trials and with these recent developments. The course 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, biotechnology companies and study sites.
Key topics to be covered include:
- The current requirements of the EU Clinical Trial 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
- New ICH GCP R2 guideline requirements
- Regulatory inspection
Why you should attend
- Decipher the framework of clinical trial regulations and guidelines in Europe
- Gain an update on the new EU Clinical Trial Regulation and the recently finalised ICH GCP R2 Guideline
- Discuss the impact of Brexit
- Understand clinical trial authorisations: regulatory and ethical approval n Realise the most important legal aspects of clinical trials
- Ensure you comply with pharmacovigilance and adverse event reporting
- Make certain you are prepared for regulatory inspections
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Programme Day One
Understand the current framework of clinical trial regulations in Europe
- Pharmaceutical clinical trial legislation – EudraLex 10 contents explained
- ICH and it’s importance
- Key FDA requirements which differ from EU requirements, e.g financial disclosure, 1572
- Potential impact of Brexit discussion
Overview and review of key areas of the EU Clinical Trial Directive
- The key requirements of the GCP Directive
- Case study – What have been the main problems of working with the Clinical Trial Directive and why is the new Clinical Regulation coming in?
Brief overview of the GCP Directive
- GCP – Which GCP standard? ICH GCP and the CT Directive
The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
- Update on the new Clinical Trial Regulation, implementing acts and EU portal and database and new documentation
- Key changes which will come in
- Group discussions on what will the main activities / issues be?
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
- Regulatory requirements for clinical trials – US IND
Ethics Committee (EC) submissions and approval
- The role of the sponsor and investigators in completing the EC applications
- Informed consent requirement
- Acceptability of global data to GCP
Programme Day Two
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 performed in children guideline compared with adults
Brief overview of legal aspects of clinical trials
- Data protection
- Enforcement and sanctions
Investigational medicinal product
- GMP requirements and the role of the Qualified Person
- The key requirements of the GMP Directive and Annex 13
- Requirements for labelling
- Consider 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?
Brief overview of other recent EU and FDA developments in clinical trial requirements including:
- Clinical Trial Transparency Requirements in the EU – new EMA policy on publication of clinical data
- EMA reflection papers including, risk-based quality management of clini- cal trials, data from third countries, Trial Master Files including electronic TMFs
- EU data protection
- FDA risk-based approaches to clinical trial monitoring
- FDA guidance electronic Informed Consent and emergency consent
- New ICH GCP (R2) Guideline – what are the key new requirements?
Brief considerations for preparing for regulatory inspection
- How to prepare for inspection
- What questions inspectors may ask
Summary and close
Dr Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
This course is ideal for anyone requiring an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on the new EU Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, 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 all other professionals who want to know more about regulations and guidelines covering clinical trials.
Venue to be announced shortly.