DDReg pharma

Quailty Driven by Passion

Submit Query

Author name: development

impact of vitro diagnostic medical device regulation in EU

Understanding the Impact of IVDR on Precision Medicine Development in the EU

All Category, Blogs /

The European Union introduced the In Vitro Diagnostic Regulation (IVDR), an elaborate regulatory framework intended to increase safety, performance and reliability of in vitro diagnostic (IVD) medical devices. Replacing its predecessor (IVDD), EU IVDR requires stricter requirements for compliance while placing greater emphasis on clinical evidence, risk classification and post market surveillance. Precision medicine, an innovative […]

Understanding the Impact of IVDR on Precision Medicine Development in the EU Read More »

Current Trends patient engagement in healthcare

Patient Engagement in Healthcare: Current Trends and Future Opportunities

All Category, Blogs, Medical Writing, Pharmacovigilance /

For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs

Patient Engagement in Healthcare: Current Trends and Future Opportunities Read More »

Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)

All Category, Blogs, Uncategorized /

Advanced Therapy Medicinal Products (ATMPs) are transforming the medical landscape, offering revolutionary treatments for diseases that previously lacked effective solutions. These products include cutting-edge innovations such as gene therapies, somatic cell therapies, and tissue-engineered products. Despite their potential, ATMPs face numerous challenges—scientific, regulatory, logistical, and financial—that hinder their development and global market access. Addressing these

Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs) Read More »

personalized drug in development

Navigating the Challenges of Personalized Medicine in Development

All Category, Blogs, Pharmacovigilance /

The landscape of modern medicine is undergoing a revolutionary transformation, with personalized medicine at the forefront. As we move away from the “one-size-fits-all” approach and embrace treatments tailored to individual genetic profiles, lifestyle, and environmental factors, the potential to improve patient outcomes has never been greater. However, this evolution also comes with unique challenges, particularly

Navigating the Challenges of Personalized Medicine in Development Read More »

Role of Real-World Evidence in Post-Marketing Safety

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally

All Category, Blogs, Pharmacovigilance /

Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of Real-World Data (RWD). RWD encompasses information collected from various sources, including electronic health records (EHRs), insurance claims, patient registries, and data from mobile health applications. This evidence is crucial in understanding

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally Read More »

artificial intelligence in drug development and drug discovery

Regulatory Challenges and Opportunities with AI in Drug Development

All Category, Blogs /

AI has emerged as a transformative force in drug development, promising to revolutionize how new therapies are discovered, tested, and brought to market. AI technologies are revolutionizing the pharmaceutical landscape. From hastening identification of potential drug candidates, to optimizing clinical trial designs and post-market surveillance – AI technologies are revolutionizing pharmaceutical innovation. AI technologies allow

Regulatory Challenges and Opportunities with AI in Drug Development Read More »

Collaboration to Prevent Drug Shortages in Healthcare

How Global Collaboration Can Prevent Drug Shortages in Healthcare

All Category, Blogs /

Drug shortages are an escalating global challenge, threatening the effectiveness of healthcare systems worldwide. These shortages occur when the supply of medications—ranging from critical life-saving drugs to essential treatments—falls short of the demand. While drug shortages have long existed, recent events such as pandemics, geopolitical conflicts, and natural disasters have highlighted the fragility of global

How Global Collaboration Can Prevent Drug Shortages in Healthcare Read More »

Concept of Patient-Centric Pharmacovigilance

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

All Category, Blogs, Pharmacovigilance /

In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing adverse drug effects or any related problems from drugs that has traditionally focused on data from healthcare providers, clinical trials and regulatory agencies. Development of

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach Read More »

Africa’s Healthcare Landscape in 2025

Evolution of Africa’s Regulatory and Healthcare Landscape

All Category, Blogs /

Africa’s healthcare and regulatory landscape have transformed to reflect the commitment of the continent to improve public health and ensure the safety and efficacy of medical products. Understanding this evolution is important for pharmaceutical manufacturing firms and professionals seeking regulatory services to navigate the African market efficiently. Historical Context The history of health in Africa is

Evolution of Africa’s Regulatory and Healthcare Landscape Read More »

Managing pharma regulatory risks with big data

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data

All Category, Insights, Regulatory /

The pharmaceutical industry’s journey into the digital age has been accelerated by the integration of big data (BD) and artificial intelligence (AI). With vast datasets from research, clinical trials, and manufacturing processes, big data provides pharmaceutical firms an unparalleled opportunity to refine processes, enhance patient outcomes, and ensure compliance with increasingly stringent regulatory requirements. However,

A Strategic Approach for Managing Pharma Regulatory Risks with Big Data Read More »