DDReg Pharma- Consulting in regulatory affairs and drug safety

Innovations such as real-world evidence (RWE) and emerging data capture technologies are shaping clinical development, leading to next-generation therapies for complex or rare diseases. The pandemic has accelerated drug development processes and increased collaboration between regulatory agencies and the industry.   Regulators are adapting to these changes, calling for new approaches and harmonization among agencies. Regulatory affairs professionals play a crucial role in navigating these complexities, strategically impacting organizations and improving patient care. By embracing innovation and collaboration, they can enhance development strategies and deliver greater value to patients. The article explores how these innovations can streamline regulatory processes, accelerate the delivery of innovative treatments, and shape a more promising future for healthcare. Real-World Evidence (RWE) and Real-World Data (RWD) Real-World Evidence and Real-World Data have emerged as pow...

New and innovative technologies, such as social media and mHealth (mobile health) technologies, have brought significant advancements to the field of pharmacovigilance. These technologies can be incorporated into pharmacovigilance services to enhance signal management and streamline Individual Case Safety Reports (ICSRs) processing and submission. However, certain challenges and considerations must be addressed to effectively harness the value of these technologies in supporting medicines regulation. Social media platforms offer unique advantages in pharmacovigilance and public health monitoring. They provide a vast volume of internet-based, patient-generated, unsolicited, continuously updated data. This abundance of data allows researchers to access a wide range of information for pharmacovigilance purposes. By analyzing social media content, including user's personal experiences with medications, potential adverse events related to specific drugs can be identified and monitored ...

It is important to break down and grasp the megatrends that are affecting industries worldwide. While these can be relatively dynamic, versatile, and complex, understanding such trends can support pharmaceutical regulatory affairs professionals in navigating the impact these trends will have on their roles, responsibilities, and work that they do on a daily basis which would drive the pharma and healthcare industries. Some of the key trends include: ·          Leveraging technological disruptors such as artificial intelligence (AI), and real world evidence (RWE) in regulatory processes. ·         Automating regulatory tasks such as regulatory intelligence, regulatory information management etc to ensure regulatory compliance. ·         Real-time regulations. ·          Exploit opportunities for global harmonization of e-submissions and support harmonization/convergence between regulatory ...