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Enhancing Medical Device Cybersecurity

Blogs, Medical Device /

The integration of wireless, Internet, and network-connected capabilities in medical devices, coupled with the frequent exchange of health information, necessitates robust cybersecurity controls. A cybersecurity threat can compromise the safety and/or effectiveness of a device by compromising the functionality of any asset in the system if there is an absence of adequate cybersecurity control. Regulatory […]

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Development of Pharmacovigilance Training Modules for US-based Educational Institute

Case Studies, Pharmacovigilance /

Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding

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Utilizing Real-World Evidence for Medical Devices

Blogs, Medical Device, Regulatory /

Recent years have witnessed a surge in clinical practice data generation outside of trials, driven by advanced signal detection technologies and expanded database capabilities. The integration of real-world data (RWD) with artificial intelligence (AI) tools is reshaping regulatory and medical decision-making. Various user-generated practice data types are stored in centralized databases, offering valuable longitudinal observations

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Online Eligibility Checker Tool for International Recognition Procedure

Blogs, Regulatory /

The International Recognition Procedure (IRP), initiated by the Medicines and Healthcare products Regulatory Agency (MHRA) post-Brexit, establishes an international recognition route for medicines with pre-existing approvals from Canada, Australia, the EU, Japan, Switzerland, and the US. Operating alongside existing national procedures, the IRP is a crucial pathway for introducing innovative medications to UK patients while

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DDReg participates in the DIA-US FDA-ANDA workshop

News and Events /

Regulatory policies that govern generic drug applications, like the Abbreviated New Drug Application (ANDA), play a crucial role in ensuring access to safe, efficacious, and high-quality generic products. Best practices in the ANDA process requires a comprehensive understanding of regulatory pathways, robust equivalence documentation, and rigorous quality control measures. Indeed, lifecycle management of approved applications

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UK MHRA: Navigating Nuances in Clinical Trial Applications

Blogs, Clinical Regulatory, Regulatory /

The UK Medicines and Healthcare products Regulatory Agency (MHRA) receives approximability 1000 clinical trial authorization (CTA) applications a year. These are for investigational medicinal products of which >95% are approved. However, >50% still need additional information to be submitted in order to get approved. The majority of the requests for additional information, including “grounds for

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Fostering bilateral trade and harmonized efforts in medicine regulation

Blogs, Regulatory /

The importance of aligning pharmaceutical regulations in the development process has become increasingly evident particularly in the current era that has characterized by global interconnectedness. Indeed, the need for harmonizing frameworks that govern medicine regulation and subsequently supporting bilateral trade has increasingly become imperative. As various pharmaceutical markets go beyond borders, disparities in their respective

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ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices

Blogs, Medical Device, Regulatory /

The medical device sector in Argentina and Brazil is experiencing robust growth and development to keep up with the demand in more comprehensive options to diagnose, prevent, and treat complicated conditions. Indeed, rising healthcare demands and an increase in the awareness of advanced medical technologies propel a surge in the adoption of innovative devices. Coupled

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