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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

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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

All Category, Blogs, Pharmacovigilance /

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

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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

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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

All Category, Blogs, Medical Writing, Pharmacovigilance /

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

All Category, 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

All Category, 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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Gene Therapy Trials in EU

Exploring the Evolving Regulatory Landscape for Gene Therapy Trials in the EU

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Gene therapy is recognized as a revolutionary approach in treating and potentially curing genetic disorders by correcting or replacing faulty genes. As the field progresses, navigating through the regulatory landscape for gene therapy trials in the European Union (EU) can be intricate due to a combination of clinical trial regulations and environmental legislation. Despite the

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Japan’s Approach to eCTD V4.0

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In the pursuit of global harmonization in pharmaceutical regulation, Japan which is renowned for its meticulous standards and innovative spirit, has taken a significant step by implementing the Electronic Common Technical Document (eCTD) v4.0. This move aligns Japan with international standards set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human

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