DDReg pharma

Quailty Driven by Passion

Author name: development

Oncology Therapeutics

Benefits of randomized control trials in accelerated approvals for oncology therapeutics

In 1992 the US FDA established the accelerated approval pathway for drug development as treatment options for serious or life-threatening conditions like cancer based on the effect the drug has on surrogate measures or an intermediate clinical end-point that could predict the real endpoint. However, these investigational drugs are subjected to post-approval confirmatory studies which […]

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Maintaining Compliance

Maintaining compliance with Identification of Medicinal Products (IDMP) standards

The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate

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DIA Europe

DDReg Exhibits at DIA Europe 2023 in Basel, Switzerland

The European Union has seen some major changes and advances in Regulatory & Healthcare Policies and strategies- a key one being the “Regulatory Science to 2025” strategy to enhance EMA’s engagement with regulatory science. The need for proactive participation in such initiatives is important to support the strengthening of regulatory systems and facilitate innovation in

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Combination Products

Pre-market pathways for combination products

The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the

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Public Health Emergencies

Mitigating medical device shortages in public health emergencies

The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw

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Orphan Drugs in Hereditary Angioedema

Access to Orphan Drugs in Hereditary Angioedema

IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation. These swelling attacks may occur unexpectedly and can significantly affect a patient’s quality of life (QoL).

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Digitalization in Regulatory Affairs

Digitalization in Regulatory Affairs

Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences

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Clinical Evaluation Report

Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER)

Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European

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