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Faster Access to Clinical Trial Information in Europe

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Improving access to clinical trial information is critical in order to advance medical research while also ensuring patient safety. Enhanced transparency can not only accelerate innovation but also empower various stakeholders to make appropriate and informed decisions in order to progress medical research forward. The European Medicines Agency (EMA) has introduced several improvements in the […]

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The Use of EDDO to Ensure Drug Delivery Function

All Category, Blogs, Medical Device /

When it comes to ensuring the safety and effectiveness of medical devices intended to deliver drugs, understanding Essential Drug Delivery Outputs (EDDO) is important. The advent of drug-device combination products has necessitated the development of robust guidelines to ensure safety, efficacy, and performance. One such crucial aspect of these combination products is the Essential Drug

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Clinical Evaluation of Orphan Medical Devices

All Category, Blogs, Medical Device /

In the European Union, the Medical Device Coordination Group (MDCG) continues to address unique challenges in the medical field, by bringing life-changing orphan medical devices to patients who suffer from rare conditions. These devices that are intended for a small number of individuals are subject to various hurdles in their development and market introduction. The

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Recommendations for the use of Animal & Human Derived Materials in Cell and Gene Therapy Products

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The number of cell and gene therapies coming into the market each year is increasing steadily. An article published by McKinsey and Company in 2022 expected as many as 21 cell therapy and 31 gene therapy launches in 2024 itself. The growing focus on cell and gene therapies (CGT) presents a unique set of challenges to

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Accelerating Product Registration with SFDA’s Priority Review

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It is important for regulatory agencies to implement priority review processes in order to expedite drug approval processes. This ensures fast access to safe innovative treatments and life-saving medicines. By streamlining drug review processes that address unmet medical needs, or offer better treatment options compared to existing therapies, these processes can accelerate patient access. This

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REMS Logic Model: Framework to link program design with assessment

All Category, Blogs, Pharmacovigilance /

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents

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Machine Learning and Simulations for Clinical Trials

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clinical trial simulation Artificial Intelligence (AI) entails the use of computer techniques that make it possible for machines to undertake activities such as perception, reasoning, learning, and decision-making. New AI forms are being developed owing to progress in technology which has fueled developments in sectors such as facial recognition, finance strategy, autonomous cars etc. The

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Comprehensive Framework for Effective Clinical Trial Dialogue

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The need for effective clinical trial dialogue is imperative to ensure clarity, consistency, and alignment with stakeholders. A comprehensive framework for effective clinical trial not only facilitates this but also helps in enhancing trial outcomes and decision-making. An estimand may be used when conducting health-related studies or interventions to help clarify how to interpret treatment

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Accelerating Clinical Trials in the European Union

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Accelerating Clinical Trials in the European Union (ACT EU) is an ambitious initiative to revolutionize clinical trials across Europe. This initiative brings together regulatory reforms, technological advancements, and collaborative processes to create a more efficient and impactful environment for clinical research. The ACT EU objective is to enable smarter clinical trials, through regulatory, technological and

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Enhancing Global Drug Development through ICH M11

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The development of new drugs is a complex process involving clinical trials conducted across multiple countries. This can lead to challenges due to differing regulatory requirements and variations in how clinical trial protocols are formatted. The International Council for Harmonization (ICH) M11 Protocol Template, based on the ICH M11 guideline, aims to address this by

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