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Author name: development

ICH: An Approach to Harmonizing Real World Data & Real World Evidence

Blogs, Regulatory /

The use of real-world data (RWD) and real-world evidence (RWE) in Life Sciences and Pharma is significantly gaining recognition for the value it brings in making enhanced regulatory decisions. The evaluation of pharmaceuticals throughout their development and lifecycle is a complex process that requires robust evidence to ensure their safety and effectiveness. Traditionally, randomized clinical […]

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US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs

Blogs, Pharmacovigilance, Regulatory /

Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)

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US FDA: Safety Reporting Requirements for Combination Products

Blogs, Pharmacovigilance, Regulatory /

In this new era, where different therapeutic realms converge, the emergence of combination products has revolutionized the healthcare landscape by providing more innovative treatment options to treat the unmet medical needs of patients. However, with great power comes great responsibility. Continuously monitoring these products and ensuring they are safe to use is paramount in order

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Challenges in Complex Generic Drug Development

Blogs, Pharmacovigilance, Regulatory /

Complex drugs add more value to patients compared to simple generics as they are capable of addressing unmet needs of patients for particular conditions. However, biopharmaceutical companies encounter distinctive hurdles when it comes to the advancement of complex generic drugs. These medications, known for their intricate characteristics or the requirement of additional clinical trials, necessitate

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US FDA: Keeping Up with the Momentum of Decentralized Clinical Trials

Blogs, Pharmacovigilance, Regulatory /

Decentralized clinical trials (DCTs) are evolving and gaining momentum within medical research as they increasingly incorporate state-of-the-art digital health technologies (DHTs). Indeed by way of DHTs, useful data for clinical trials can be collected, exchanged, transferred, and stored electronically and in a more efficient manner. In order to stay aligned with the momentum, regulatory agencies

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Innovative Medicines

Evaluating PRIME: A Pathway for Innovative Medicines

Blogs, Regulatory /

In various therapeutic areas where life expectancy is low, delayed market access to effective medicines has highlighted the need for expedited responses by regulators to support timely access to such priority medicines. The Priority Medicines Scheme, or PRIME, was implemented by the European Medicines Agency (EMA) to support and accelerate medicine development that targets unmet

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Accelerating access to Women’s Health products

Case Studies, Regulatory /

Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they

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High Impact Manager Program

DDReg & Oktane HR – “High Impact Manager Program”

News and Events /

DDReg places a strong emphasis on continuously nurturing and expanding its leadership team to drive long-term organizational success. In line with this vision, DDReg was fortunate to have been supported by Oktane HR- a leadership and growth focussed consultancy that is dedicated to refining leadership capabilities and learning. Principal consultant, Mr. Sunil Bhardwaj, and Lead

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Web-based Lifecycle Management Tool

Case Studies, Regulatory /

Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the

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