DDReg Pharma

DELIVER BETTER DATA TO ENSURE FASTER APPROVAL
DDReg Pharma
+1 (302) 601-2755

Pharmacovigilance

Commitment to Biological Product and Patient Safety in India

Blogs, Pharmacovigilance, Regulatory / By

Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives.  Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to …

Commitment to Biological Product and Patient Safety in India Read More »

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability

Blogs, Pharmacovigilance, Regulatory / By

In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is …

Asserting Patient Rights: The Importance of Labels for Medical Device Traceability Read More »

Strengthening Safety Compliance in Somalia

Blogs, Pharmacovigilance / By

The National Medicine Regulatory Authority (NMRA) of the Ministry of Health regulates and controls regulatory & safety related operations for pharmaceuticals in Somalia. It is responsible for facilitating the availability and accessibility of safe and effective medicines to the Somalian population. More recently, the Somalian NMRA issued their very first Somali Pharmacovigilance Guideline with the …

Strengthening Safety Compliance in Somalia Read More »

SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products

Blogs, Pharmacovigilance / By

Efficiently detecting safety signals for veterinary products is crucial for safeguarding animal health and ensuring the well-being of both animals and humans. Rapid identification of potential risks allows for timely intervention, preventing widespread harm. Recognizing the significance of this, global authorities are actively working to fortify safety signal reporting. Establishing regulatory guidelines ensures a standardized …

SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products Read More »

Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid

Blogs, Pharmacovigilance / By

Pharmacovigilance in India has come a long way over the last few years especially for proactively detecting safety signals for pharmaceutical products. It is an indispensable component of the pharmaceutical industry in India, ensuring the safety and efficacy of drugs in the market. This comprehensive field includes various sub-categories, each contributing to the overall goal …

Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid Read More »

Development of Pharmacovigilance Training Modules for US-based Educational Institute

Case Studies, Pharmacovigilance / By

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 …

Development of Pharmacovigilance Training Modules for US-based Educational Institute Read More »

Kenya’s Systematic Approach to Pharmacovigilance

Blogs, Pharmacovigilance / By

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 »

ISoP: The Need for Patient Engagement in Pharmacovigilance

Blogs, Pharmacovigilance / By

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 »

Ensuring Safe Use of Medical Devices in Healthcare Facilities

Blogs, Medical Device, Pharmacovigilance / By

The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result …

Ensuring Safe Use of Medical Devices in Healthcare Facilities Read More »