Latest RWE News and Insights - Including Significant Reform of Italian RECs

Italy - Significant Reform of Research Ethics Committee Network

As of 7 June 2023, the number of ethics committees competent to review drug observational studies in Italy is reduced from 90 to 40.?This significant reform of the Italian ethics committee network aims to reduce the bureaucracy associated with clinical trials (primarily) and drug observational studies.

This change was implemented through, Decree 26 January 2023 - Identification of Forty Territorial Ethics Committees [Link].

This reform is likely to significantly impact the availability of review slots and approval times during the transitional period, before a new status quo is established.

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France - CNIL Publishes it's AI Action Plan [Link]

Global - Draft Revision 3 of ICH E6 (GCP) Published [Link]

Global - ICJME Recommendations Updated [Link]

Italy - New Publication from the National Coordination Center of Territorial Ethics CommiMees (CCNCE) on the Ethical and Regulatory Issues in the Processing of Personal Health Data in Observational Research [Link] [Full Article]

Japan - Personal Information Protection Commission Publishes Global Strategy for Data Flow and Data Sharing [Link]

Spain - New AEPD Guidelines to Validate Encryption as a Security Measure for Personal Data [Link]

UK - MHRA and Genomics England to Launch Pioneering Resource to Better Understand How Genetic Makeup Influences the Safety of Medicines [Link]

• Ethical Foundation of RWE Research [Link]
• The Declaration of Helsinki [Link]
• Ethics Principles and Safeguards for Medical AI in the Context of RWE [Link]
• Is ICH GCP Applicable to Non-Interventional Studies [Link]
• EMA Good Pharmacovigilance Practices (GVPs) [Link]
• ISPE GPP [Link]
• The Patient Voice [Link]
• Diversity [Link]
• Patient Registries [Link]
• Registry vs Registry-Based Study [Link]
• DARWIN-EU [Link]
• The Impact of the EMAS Data Quality Framework on RWE [Link]
• The European Health Data Space (EHDS) [Link]
• Federated Clinical Data [Link]
• EHDS and GDPR - How Does GDPR Support the Secondary Use of Existing Health Data for the Purposes of Scientific Research? [Link]
• Is Retrospective Data the Same as 'Secondary Use of Existing Data'? [Link]
• Acknowledgement of the Limitations of Clinical Trials and RWE Studies [Link]
• Challenges Pharma Companies Face When Using RWE to Support Marketing Authorisations [Link]
• Challenges in RWE Generation (Regulatory Grade RWE?) [Link]
• Verifying the Source of Data (Not to be condused with 'source data verification', Yup! Confusing!) [Link]
• The Role of RWE in Health Technology Assessments (HTAs) [Link]
• NICE Real World Evidence Framework [Link]
• Regulatory Science [Link]
• Regulatory Intelligence [Link]
• Regulatory Compliance [Link]
• The Importance of Regulatory Definitions [Link]
• Are the Terms 'Clinical Study' and 'Clinical Trial' Synonymous in the Context of Non-Interventional Studies? [Link]
• Interventional Clinical Trial vs Non-Interventional Study [Link]
• Postmarket Requirements (PMRs) vs Post-Authorisation Safety Studies (PASS) [Link]
• Are Non-Interventional Studies Regulated? [Link]
• The Tuskegee Syphilis Study [Link]
• The Common Rule [Link]
• HIPAA [Link]
• Seeding Studies [Link]
• Why Should Non-Interventional Studies Not be Promotion? [Link]
• Principles for Ensuring Research Results are Reliable, Valid, and Objective [Link]

NIS Considerations - Sweden: This training session describes the regulatory requirements and operational considerations when running non-interventional studies (NIS) in Sweden [Link].

NIS Considerations - Switzerland: This training session describes the regulatory requirements and operational considerations when running non-interventional studies (NIS) in Switzerland [Link].

Real World Research (RWR) refers to the collection of patient-related data in a real-world environment (real-world data) and obtaining clinical evidence (real-world evidence) of the value and potential benefits or risks of the medical products through analysis [Link].

ABOUT STUART MCCULLY...

Stuart is a real world research (RWR) industry expert and thought leader.?With his background as a pharmacologist working on traditional pre-approval clinical trials, he became frustrated with the operational inefficiencies and support gaps for non-interventional (observational) studies. As a result, Stuart created CHCUK which became a global leader in supplying regulatory and operational intelligence for non-interventional studies. Currently, Stuart is a co-founder of RWR-Regs, a regulatory compliance solutions platform for real world research.

Stuart regularly provides RWR regulatory science advice, guidance and training to top 10 Pharma, Biotech, Medical Device companies and CROs.