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DDReg Exhibits at the BIO International Convention 2024

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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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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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Leveraging Statistical Approaches in Drug Safety Analysis

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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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Data Integrity for In Vivo BABE Studies

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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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Redesigned Pre-Submission Meetings for ANDAs with the US FDA

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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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Electronic Submissions for Investigational New Drug Safety Reports

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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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A Collaborative Approach Towards Integrating Artificial Intelligence in Medical Products

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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

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Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products

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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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Pharmacovigilance in New Zealand

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Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides

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