Clinical Trial Regulatory Requirements Training Course: Understand the Impact of the New EU Requirements in the United States

DUBLIN, Sept. 4, 2023 /PRNewswire/ — The “Clinical Trial Regulatory Requirements Training Course” conference has been added to ResearchAndMarkets.com’s offering.

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 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 (GCPauditors); 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.

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) one year after going live. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.

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
ICHGCP 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
Assess the most important legal aspects of clinical trials
Ensure you comply with pharmacovigilance and adverse event reporting

Agenda

Day 1

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

The New EU Clinical Trials Regulation One Year After Go Live

Update one year after the Go Live implementation of the new 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

Ethics Committee (EC) Approval at National Level

EC applications as part of the Clinical Trials National Approval
Informed consent requirements
Ethical considerations for running trials including countries outside of traditional countries

Day 2

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)

The CTIS (Clinical Trial Information System)

What is CTIS?
How to use CTIS
Transitioning trials

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)
Reflection Paper on the Use of Interactive Response Technologies with Particular Emphasis on the Handling of Expiry Dates
Accelerating Clinical Trials in the EU
Covid regulatory Guidance
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

ICH update

Regulatory Inspection

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

Speakers:

Laura Brown

Pharmaceutical QA and Training Consultant

University of Cardiff

Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.

For more information about this conference visit https://www.researchandmarkets.com/r/g8x99e

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