Drug safety is all about the right patient receiving the right drug at the right time for an improved outcome for each patient. To achieve this, a Qualified Person Responsible for Pharmacovigilance (QPPV) is held responsible for the pharmacovigilance management of the quality of a pharmaceutical company. This could be a person who encourages action, …
The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, pharmaceutical industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry faces …
The impact of the Russia-Ukraine war on clinical trials Read More »
The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a specific health topic of concern to people all over the world. The onset of the pandemic has created history and has affected billions of people …
RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical organizations …
DDReg’s RegTech space: your regulatory solution for achieving rapid market access Read More »
The healthcare ecosystem is driven by several factors. Government vision, successful partnerships, modern legislation, and adoption of innovation are some of the most crucial ones from a regulation point of view. Regulatory affairs (RA) bridge the gap between regulatory authorities and market access for drugs allowing patient empowerment by increasing drug availability. With ever-changing laws, …
DDReg Pharma: Silver Sponsors of the 7th GCC Pharma Summit 2022, Dubai, UAE Read More »
Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory framework for biosimilars …
Biologics development & regulatory approval – EMA perspective Read More »
A biological drug (or biologic) is one that is produced from a living organism or contains components of a living organism. They have become indispensable tools in modern medicine, for treatment of life-threatening conditions. With an aging population and a growing demand for treating chronic conditions, biologic use is on the rise. However, they are …
Biosimilarity and Interchangeability in the MENA region Read More »
Smart regulatory processes and regulatory intelligence have evolved over past decade. Human race has finally transferred its knowledge and experience to machines for smart processing. Automation of processes, use of AI & ML have gained a lot of traction and are now the new competitive battleground. Technology is keeping pace with the rapidly changing regulatory …
Over the last five years, biosimilars have progressively gained traction. Global sales are expected to more than double to $15 billion by the early 2020s, with emerging markets accounting for $5 billion to $8 billion. Multinational organizations seeking their entrance into emerging markets of the world focus on the biologic-treatment rates of countries and are …
In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months. …
