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Two advice pilots to improve clinical trials in Europe

Accelerating Drug Development with Europe’s New Clinical Trial Pilots

Blogs, Clinical Regulatory, Regulatory /

The journey from discovering a promising compound to its approval as a safe, effective drug is challenging and costly, involving rigorous clinical trials to ensure public health and patient safety. The European Union responds to the need for speed and efficiency by transforming how clinical trials are conducted. The Accelerating Clinical Trials in the EU […]

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a scenario for biosimilar cell and gene therapies

What does the scenario of biosimilar cell and gene therapies look like?

Blogs, Regulatory /

Cell and gene therapy (CGT) products are gradually paving the path to provide novel treatment options for patients that have complex conditions related to cancers, genetic disorders, and other chronic conditions. However, CGT products are also associated with barriers related to cost that could significantly affect or delay patient access to these life-changing therapies. Indeed,

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Safety Reporting Requirements in ctd to ctr transition

Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition

Blogs, Clinical Regulatory, Regulatory /

Since 2004, clinical trials (CTs) in the European Union (EU) have been governed by the Clinical Trials Directive (CTD) 2001/20/EC. This directive aims to harmonize the administrative requirements governing CTs across EU Member States. Each Member State (MS) has its own set of procedures, requirements, and timelines for CT operations. However, there was a need

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FDA Update REMS Public Dashboard

FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access

Blogs, Pharmacovigilance, Regulatory /

The U.S. Food and Drug Administration has launched the REMS (Risk Evaluation and Mitigation Strategy) Public Dashboard to enhance access to data related to REMS programs using an interactive, secure, and web-based tool. Such a dashboard will help streamline user-friendly access for health care providers, research organizations, academia, industry professionals, and the general public to

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Pharmaco-Epidemiological Studies with ICHs M14

Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14

Blogs, Clinical Regulatory, Regulatory /

Imagine a pharmaceutical company about to launch a new drug. Clinical trials have shown promising results, but the real test lies in how this drug will perform in the hands of thousands—or even millions—of patients in the real world. Will it be as effective? Will unexpected safety issues arise? The answers to these questions often

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Post-Approval Manufacturing Changes in Biosimilar

Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA

Blogs, Regulatory /

After a biosimilar or interchangeable product gets regulatory approval by the USFDA, manufacturers often need to adjust their manufacturing processes. These changes after approval are essential for keeping product consistency, enhancing processes, or tackling operational issues. However, because biologics are complex, even small modifications can significantly affect the product’s safety, efficacy, and quality. As a

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Declaration of Helsinki 2024

Updates to the Declaration of Helsinki

Blogs, Medical Writing, Pharmacovigilance, Regulatory /

The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants

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EU Classification of AI medical devices and IVDs

Navigating EU Classification Standards for AI in Medical Devices and Diagnostics

Blogs, Medical Device /

The European Union (EU) has introduced stringent classification standards for Artificial Intelligence (AI) applications in medical devices and in vitro diagnostics (IVDs) to ensure patient safety, product efficacy, and compliance with regulatory frameworks. With AI technologies, these standards are crucial in defining the pathway for their integration into healthcare systems. This blog dives into the

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Total Product Life Cycle Advisory Program in Medical Devices

Enhancing Medical Device Innovation with the Total Product Life Cycle Advisory Program

Blogs, Medical Device /

The medical device industry is driven by constant technological advancements and the need to meet growing patient demands. Ensuring that these innovations are safe, effective, and reach the market promptly is a critical aspect of public health. To address this need, the FDA has implemented the Total Product Life Cycle (TPLC) Advisory Program (TAP), a

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