Dublin, May 30, 2024 (GLOBE NEWSWIRE) -- 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 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
Certification
- CPD: 12 hours for your records
- Certificate of completion
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
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
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)
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.
For more information about this conference visit https://www.researchandmarkets.com/r/5eavhx
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
