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Author name: development

Integrating Real-World Data into Regulatory Practices of Electronic Health Records and Medical Claims

Blogs, Pharmacovigilance, Regulatory /

As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential […]

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EU Updated SOHO Regulations in 2024

The Future of ATMPs under EU’s Updated SoHO Regulations

Blogs, Clinical Regulatory, Regulatory /

The Advanced Therapy Medicinal Products (ATMPs) regulation was and covers gene therapy, somatic cell therapy, and tissue-engineered products. The ATMP’s requirements for the development, manufacturing, approval, and post-marketing surveillance for these products are regulated under regulation (EC) No. 1394/2007 and Directive 2001/83/EC in the European Union (EU). Stringent regulatory agencies, like the European Medicines Agency

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Navigating the New Requirements for Diversity in Clinical Trials

Blogs, Clinical Regulatory, Regulatory /

In recent years, the emphasis on diversity in clinical trials has become more prominent, reflecting the need for studies on more diverse populations to gather more accurate clinical findings. The lack of diversity in participants can create an obstacle to understanding the safety and efficacy of new medicines, making it more difficult to understand the

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Guidance Nonclinical Development of Oligonucleotide

FDA’s First Draft Guidance on Nonclinical Development of Oligonucleotides

Insights, Regulatory /

The rapid evolution of biotechnology has positioned oligonucleotide-based therapeutics as one of the most promising therapeutic innovations in medicine today. From antisense oligonucleotides (ASOs) to small interfering RNAs (siRNAs) mRNA, and guide RNAs (gRNAs), these molecules are reshaping how we approach previously untreatable conditions. Recognizing the potential and complexity of this expanding area, and the

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Key updates in ICH Q2 and Q14 guidelines for biologics

What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions

Blogs, Regulatory /

The rapid advancement of biologics and the complexity of their development requires a meticulous approach to analytical procedures. With the revisions to the ICH Q2(R2) (Validation of Analytical Procedures) and the introduction of ICH Q14 (Analytical Procedure Development), biologics developers now have updated guidelines designed to address the unique challenges presented by these complex therapeutic

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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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Quantiphi, DDReg Partnership For AI Regulatory Reporting

Quantiphi, DDReg Partner to Transform Regulatory Reporting in Life Sciences Through AI

News and Events /

Gurgaon, INDIA –  Quantiphi, a global AI-first digital engineering company and DDReg, a global leader in regulatory expertise today announced a partnership that will address regulatory challenges that pharmaceutical companies, biotechnology firms, medical device and cosmetics manufacturers face by bringing innovations to market more quickly through AI. Neeti Pant – DDReg Managing Director, said “DDReg

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