The Drug Information Association (DIA) Global Annual Meeting 2024 was a premier gathering for professionals in the life sciences and healthcare industries. Hosted in San Diego, from June 16th to 20th, the conference served as a platform for the exchange of knowledge, insights, and innovations related to drug development, regulatory science, clinical trials, and healthcare […]
DDReg Exhibits at the DIA Global Annual Meeting 2024 Read More »
The BIO International Convention in San Diego was an exciting and vibrant event, bringing in-depth insight to the latest developments within the biotech and pharmaceutical sectors.- and DDReg was thrilled to have been exhibiting there! The prestigious convention brought together leaders, innovators, and professionals from the biotech and pharmaceutical sectors and provided the perfect platform
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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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Drug safety in clinical trials is ensured through the application of statistical approaches. Adequate planning for safety analyses helps in identifying potential adverse events, evaluating their impact and ensuring that the benefits of a drug are greater than the risks associated with it. It starts from early stages i.e., with the designing of clinical trials
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Medical research is progressing rapidly to keep up with the increase in complex disease. This has highlighted the need for innovation in clinical trials that can be driven by enhanced communication and collaboration. Stakeholders such as clinicians, researchers, patients, etc. can accelerate the development of novel therapies in order to improve patient outcomes by enabling
Center for Clinical Trial Innovation Read More »
The pharmaceutical industry is evolving with technological advancements with a subsequent increase in regulatory scrutiny that emphasizes maintaining the accuracy, completeness, and reliability of data- it has become more critical than ever. Data integrity ensures that information is trustworthy, verifiable, and compliant with regulatory standards. It is essential for safeguarding patient well-being, supporting regulatory approvals,
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Pre ANDA meetings facilitate pre-submission communications with the US FDA to discuss questions related to complex products and/or complicated drug development questions. These were introduced in GDUFA II. In the GDUFA III some pre submission meetings have been redesigned to support prospective applicants in obtaining feedback from the Agency regarding their complex generics or complicated
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Regulatory agencies like the United States’ FDA are increasingly encouraging electronic submission of Investigational New Drug (IND) safety reports. Electronic submission has numerous advantages over traditional paper-based submissions such as efficiency, accuracy, accessibility, timeliness and standardization. IND clinical trial sponsors are required to submit the IND safety report of serious and unexpected suspected adverse reactions
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Imagine a world where medical care is not just about treatment but about prediction and prevention. This is what artificial intelligence (AI) in healthcare promises, while also supporting innovation. Regulatory agencies across the globe recognize that AI technology work through a complex series of various processes, highlighting the need for end-to-end management across the lifecycle
A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products Read More »
Advanced therapy medicinal products (ATMPs) including gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer a major hope for various diseases for which there are limited or no therapeutic options and therefore, have been a subject of considerable interest. Given the increase in
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