DDReg pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
DDReg Pharma

Author name: development

ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices

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 […]

ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices Read More »

Advancing Healthcare through Electronic Product Information

Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI

Advancing Healthcare through Electronic Product Information Read More »

DDReg Participates in India Pharma Awards 2023 for Excellence in Ancillary Pharma Services

DDReg participated in the 10th edition of the prestigious India Pharma Awards 2023 for Excellence in Ancillary Pharma Services, an event designed to acknowledge outstanding achievements and inventive strides within the pharmaceutical sector. DDReg participation showcased its dedication to contributing to the pharmaceutical industry. The event celebrated industry accomplishments and contributions, bringing together champions and

DDReg Participates in India Pharma Awards 2023 for Excellence in Ancillary Pharma Services Read More »

How is EMA Addressing Medicine Shortages in Europe?

The emergence of drug shortages as a significant global health concern is evident. Organisations including the European Medicines Agency (EMA) express concerns about long-term medicine availability, emphasizing the need for continuous access to high-quality, affordable essential medicines.  Shortages lasting days or months jeopardize patient outcomes, straining healthcare systems. EMA has introduced a solidarity mechanism, developed

How is EMA Addressing Medicine Shortages in Europe? Read More »

Kenya’s Systematic Approach to Pharmacovigilance

Pharmacovigilance (PV) and drug safety surveillance activities rely on a robust PV system. This is important to effectively identify, evaluate, and address any adverse events (AEs) that are associated with medicinal products. Indeed, a proficient PV system facilitates data gathering that is critical for making informed decisions across various health systems. Regulatory agencies are reliant

Kenya’s Systematic Approach to Pharmacovigilance Read More »

MHRA’s AI-Airlock for Safe Development of Medical Technologies

The use of artificial intelligence (AI) in the Pharmaceutical and Health Care industries has paved the way for more innovative opportunities to help enhance patient outcomes. This is with respect to the diagnosis, treatment, and overall personalized patient care. However, as these technologies evolve, so do the challenges especially when it comes to testing these

MHRA’s AI-Airlock for Safe Development of Medical Technologies Read More »

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices

As more artificial intelligence (AI) and machine learning (ML) technologies become increasingly available, the uniqueness of medical devices also evolve. Though AI/ML-driven devices provide support for diagnosing and treating more complex conditions, their unique features highlight the need for a more harmonized approach towards device regulation for patient safety. Regulators across the globe are gradually

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices Read More »

ISoP: The Need for Patient Engagement in Pharmacovigilance

Pharmacovigilance is paramount for the well-being of patients exposed to pharmaceutical products. To ensure the effectiveness of pharmacovigilance systems professionals from various scientific disciplines contribute in diverse manner. Several organizations collaborate to ensure best global pharmacovigilance practices for patient safety. Among these key organizations is the International Society of Pharmacovigilance (ISoP) that is dedicated to patient

ISoP: The Need for Patient Engagement in Pharmacovigilance Read More »

AMDF: Ensuring the Safety of Donated Medical Devices

In times of emergencies like war, disease outbreak, natural disasters etc that lead to a rise in casualties, humanitarian support such as donations may be required. These donations can range from basic items like clothing to more technical complex items such as medical devices. While donations can be crucial during emergencies, they also bring challenges

AMDF: Ensuring the Safety of Donated Medical Devices Read More »